Everolimus-Coated Percutaneous Transluminal Coronary Angioplasty Catheter First in Human Clinical Investigation: A Clinical Evaluation in the Treatment of Subjects With In-Stent Restenosis of Previously-treated Coronary Artery Lesions
Phase: NA
Conditions: In-stent Restenosis
Sponsor: Abbott Medical Devices

CONFIDENTIAL
Page 1 of 74
Chansu Vascular Technologies Everolimus-Coated Percutaneous 
Transluminal Coronary Angioplasty Catheter First in Human Clinical 
Investigation
A Clinical Evaluation in the Treatment of Subjects with In-Stent Restenosis of 
Previously-treated Coronary Artery Lesions
The CVT-ISR Trial
PROTOCOL
Protocol Number:
TP1125
Revision:
A
Lead Principal Investigator:
In Country Lead Investigators:

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TP1125 Revision A
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Data Management/Data Analysis:
Angiographic Core Laboratory:
Sponsor:
Chansu Vascular Technologies, LLC
DCO Number, Effective Date:
DCO#0090, 22-Sept-2021

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TABLE OF CONTENTS 
PROTOCOL SIGNATURE PAGE ........................................................................................................ 6 
REVISION HISTORY ............................................................................................................................. 7 
PROTOCOL SUMMARY ....................................................................................................................... 8 
1. 
STUDY OVERVIEW AND RATIONALE ............................................................................... 12 
1.1 
Study Overview ...................................................................................................................... 12 
1.2 
Background and Literature Review ....................................................................................... 12 
1.3 
Study Rationale ..................................................................................................................... 13 
2. 
DESCRIPTION OF THE STUDY DEVICE............................................................................ 14 
2.1 
Basic Catheter Specifications................................................................................................ 14 
2.2 
Indication .............................................................................................................................. 15 
3. 
STUDY DESIGN ........................................................................................................................ 15 
3.1 
Endpoints ............................................................................................................................... 16 
3.2 
Primary Safety Endpoint ....................................................................................................... 16 
3.3 
Primary Effectiveness Endpoint ............................................................................................ 16 
3.4 
Other Clinical Endpoints ...................................................................................................... 16 
3.5 
Angio-IVUS-OCT Endpoints ................................................................................................. 17 
3.6 
Study Population ................................................................................................................... 17 
3.7 
Ethical Considerations .......................................................................................................... 18 
3.8 
Subject Inclusion Criteria ..................................................................................................... 18 
3.9 
Subject Exclusion Criteria .................................................................................................... 18 
3.10 
Subject Enrollment Point ...................................................................................................... 19 
3.11 
Subject Discontinuation ........................................................................................................ 19 
3.12 
Early Termination of the Clinical Trial ................................................................................. 20 
4. 
CONDUCT OF THE STUDY .................................................................................................... 20 
4.1 
Baseline Assessments............................................................................................................. 21 
4.2 
Concomitant Medical Therapy .............................................................................................. 21 
4.3 
ISR PTCA Procedure .............................................................................................................. 23 
4.4 
Post-Procedure Subject Management ................................................................................... 26 
4.5 
Pre-Discharge Assessments................................................................................................... 26 
4.6 
Subject Follow-up Post Hospital Discharge ......................................................................... 26 
5. 
ADVERSE EVENTS .................................................................................................................. 29 
5.1 
Adverse Events ...................................................................................................................... 29 
5.2 
Anticipated Adverse Events ................................................................................................... 29 
5.3 
Adverse Event Severity .......................................................................................................... 32 
5.4 
Relationship to Study Device ................................................................................................. 32 
5.5 
Serious Adverse Events.......................................................................................................... 34 
5.6 
Procedures for Reporting Serious Adverse Event ................................................................. 34 
6. 
STATISTICAL DESIGN AND ANALYSIS ............................................................................ 35 
6.1 
Statistical Overview of the Trial ........................................................................................... 35 
6.2 
Analysis Populations ............................................................................................................. 36 
6.3 
Sample Size Justification ....................................................................................................... 36 
6.4 
Statistical Analyses ................................................................................................................ 37 
7. 
RISK ASSESSMENT ................................................................................................................. 37 
7.1 
Potential Risks from Percutaneous Coronary Diagnostic and Treatment Procedures ........ 37 
7.2 
Potential Risks from Everolimus Coating ............................................................................. 38 
7.3 
Risk Management Procedure ................................................................................................ 39 

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7.4 
Potential Benefits .................................................................................................................. 39 
8. 
DATA HANDLING, RECORD KEEPING AND REPORTING ............................................ 39 
8.1 
Case Report Form (CRF) Completion .................................................................................. 39 
8.2 
Source Documentation .......................................................................................................... 40 
8.3 
Reports .................................................................................................................................. 40 
9. 
REGULATORY REQUIREMENTS ........................................................................................ 40 
9.1 
Investigator’s Responsibility ................................................................................................. 40 
9.2 
Compliance with Protocol and Protocol Amendments ......................................................... 40 
9.3 
Investigator Requirements ..................................................................................................... 40 
9.4 
Institutional Requirements .................................................................................................... 41 
9.5 
Informed Subject Consent ..................................................................................................... 41 
9.6 
Device Accountability ............................................................................................................ 41 
9.7 
Use of Information and Publication ...................................................................................... 41 
9.8 
Reporting Requirements ........................................................................................................ 42 
10. 
SPONSOR RESPONSIBILITIES COMPLIANCE/QUALITY ASSURANCE ................... 43 
10.1 
Role of Sponsor ..................................................................................................................... 43 
10.2 
General Duties ...................................................................................................................... 43 
10.3 
Selection of Clinical Investigators and Sites ......................................................................... 43 
10.4 
Training of Investigator and Site Personnel and Monitoring ............................................... 43 
10.5 
Investigator's Brochure ......................................................................................................... 43 
10.6 
Documentation ...................................................................................................................... 43 
10.7 
Committees ............................................................................................................................ 43 
11. 
TRIAL TERMINATION ........................................................................................................... 44 
12. 
APPENDICES ............................................................................................................................ 44 
APPENDIX A: BIBLIOGRAPHICAL REFERENCES..................................................................... 46 
APPENDIX B:  TRIAL ABBREVIATIONS AND DEFINITIONS .................................................. 51 
APPENDIX C: INFORMED CONSENT: LBL1120 .......................................................................... 58 
APPENDIX D:  DECLARATION OF HELSINKI ............................................................................. 59 
APPENDIX E: INSTRUCTIONS FOR USE: LBL1121 .................................................................... 64 
APPENDIX F: SCHEDULE OF EVENTS .......................................................................................... 65 
APPENDIX G: RESEARCH AGEEMENT TEMPLATE: FRM1122 ............................................. 67 
APPENDIX H: INVESTIGATOR’S RESONSIBILITIES ................................................................ 68 
APPENDIX I: ANGIOGRAPHIC CORE LAB GUIDELINES AND WORKSHEET ................... 70 
APPENDIX J: RISK ANALYSIS ......................................................................................................... 71 
APPENDIX K: GENERAL SAFETY AND PERFORMANCE REQUIREMENTS STATEMENT
 ...................................................................................................................................................... 73 
APPENDIX L: CASE REPORT FORMS: FRM1123 ........................................................................ 74 
 
 
 
 
 
 

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TABLE OF FIGURES 
Figure 1.  CVT-ISR Study Participation Flow Chart ...................................................................................... 16 
 
TABLE OF TABLES 
Table 1. CVT Everolimus-coated PTCA Catheter Size Matrix and Total Drug Content............................... 15 
Table 2. CVT-ISR Study Required Antiplatelet Medication Regimen .......................................................... 22 
Table 3. CVT-ISR Study Pre-Procedure, Procedural, Discharge and Follow Up Activities .......................... 28 
Table 4. CVT-ISR Study Site Responsibilities for Submitting Data and Reports.......................................... 42 
 
 

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PROTOCOL SIGNATURE PAGE 
 
 
 
 
The CVT-ISR Trial 
Chansu Vascular Technologies Everolimus-Coated Percutaneous Transluminal Coronary 
Angioplasty Catheter First in Human Clinical Investigation: 
A Clinical Evaluation in the Treatment of Subjects with In-Stent Restenosis of Previously-treated 
Coronary Artery Lesions 
 
I have reviewed this protocol, including the investigator’s brochure, and agree to adhere to the 
requirements and responsibilities listed herein. I am trained to the contents of this protocol, 
percutaneous angioplasty procedures, and the specific use of the device listed in this protocol. I will 
ensure that the study is conducted in compliance with the protocol, Good Clinical Practices, 
Declaration of Helsinki and all applicable regulatory requirements. 
 
 
 
 
Site Investigator Signature 
 
 
 
 
Date 
 
 
Site Investigator Printed Name 
 
 
 
Sponsor Signature 
 
 
 
 
 
Date 
 
 
Sponsor Printed Name 
 
 
 

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REVISION HISTORY 
Revision 
Level 
DCO 
Number 
Effective Date 
Description of Change 
01 
0036 
18-May-2021 
N/A, Initial release 
02 
0048 
09-Jun-2021 
Update Section 5 for SAE definitions and notification 
per MDR 2017/745. 
03 
0074 
24-Aug-2021 
Updated principal investigators on page 1; clarified 
conduct physical exam versus physical questionnaire: 
when each occurs (Table 3, Appendix F) and what is 
included in each (Section 4.1 and Section 4.6). 
Updated Appendix L with risk analysis information 
from RMF1018. Revised angiographic core lab to 
“TBD”. 
A 
0090 
22-Sep-2021 
Released document to alpha revision level; updated 
angiographic core lab information from TBD to Yale 
University. Clarified sheath size as 6Fr or larger. 
Rounded the drug content in Table 1 to whole 
numbers. Added angiographic core lab technician 
worksheet and collection instructions to Apnedix I.  
Removed Appendices J and K (IVUS and OCT Core 
Lab Guidelines); renumbered remaining appendices. 
 
 
 
 
 

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PROTOCOL SUMMARY 
Investigational 
Device 
CVT Everolimus-coated Percutaneous Transluminal Coronary Angioplasty 
(PTCA) Catheter  
Study Objective 
To assess the safety and inhibition of restenosis of the CVT Everolimus-
coated PTCA Catheter in the treatment of subjects presenting in-stent 
restenotic lesions in native coronary arteries. 
Study Design 
Prospective, multi-center, open, single arm study enrolling subjects with 
visually estimated nominal vessel diameter ≥2.0 mm and ≤3.5mm and lesion 
length ≤24 mm receiving up to two (2) CVT Everolimus CVT EVE-PTCA 
Catheters. 
Angiographic follow up, in combination with with either Intravascular 
Ultrasound (IVUS) or Optical Coherence Tomography (OCT), follow-up, will 
be carried out in a subset of 25 patients at 180 days following the index 
procedure. 
Patient enrollment 
A total of 50 subjects will be enrolled 
Number of Sites 
Up to fifteen (15) clinical sites in Europe  
Primary Safety 
Endpoint 
Freedom from target lesion failure (TLF) rate at 6 months post-index 
procedure, defined as a composite rate of cardiovascular death, target vessel 
myocardial infarction and clinically-driven target lesion revascularization 
(TLR). 
Primary 
Effectiveness 
Endpoint 
In-stent late lumen loss (LLL) at 180 days post-procedure. 
Other Clinical 
Endpoints 
x Target lesion failure (TLF) at 30 days, 1, 2 and 3 years post-procedure, 
defined as a composite rate of cardiovascular death, target vessel 
myocardial infarction and clinically-driven target lesion revascularization 
(TLR). 
x Target vessel failure (TVF) at 30 days, 180 days, and 1, 2 and 3 years 
post-procedure, defined as a composite rate of cardiovascular death, target 
vessel myocardial infarction, and target vessel revascularization (TVR). 
x Clinically-driven target lesion revascularization (TLR) at 1, 2 and 3 years 
post-procedure. 
x Clinically-driven target vessel revascularization (TVR) at 180 days and 1, 
2 and 3 years post-procedure. 
x Rate of vascular access site complication, defined as the combined rate of 
hematoma, AV fistula or a pseudoaneurysm that required intervention, 
such as surgical repair or transfusion, prolonged hospital stay or required a 
new hospital admission. 
x Lesion success (per device), defined as achievement of a final in-lesion 
residual diameter stenosis of <30% (by QCA), using any device after wire 

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passage through the lesion. Pre- and post-dilatation of the lesion with a 
non-study device is considered part of assigned device treatment. 
x Technical success (per device), defined as achievement of a final in-lesion 
residual diameter stenosis of <30% (by QCA), using the CVT Everolimus-
coated PTCA Catheter without a device malfunction after wire passage 
through the lesion. Pre- and post-dilatation are considered part of assigned 
device treatment. 
x Clinical success (per subject) defined as technical success without the 
occurrence of major adverse cardiac events during the procedure. 
x Procedural success (per subject) defined as lesion success without the 
occurrence of major adverse cardiac events during the procedure. 
Angiographic, IVUS 
and OCT Endpoints 
Angiographic endpoints (subset of 25 subjects): 
x In-segment LLL at 180 days 
x In-stent and in-segment % diameter stenosis (%DS) at 180 days 
x In-stent and in-segment angiographic binary restenosis (ABR) rate at 
180 days 
IVUS endpoint (subset of 15 subjects): 
x In-stent % volume obstruction (%VO) at 180 days 
OCT endpoints (subset of 10 subjects): 
x % of stent strut coverage at 180 days 
Subject 
Population 
Subjects with documented in-stent restenosis in native coronary arteries. 
Treatment Strategy 
x Treatment of a single in-stent restenosis coronary artery lesion with up 
to two (2) CVT Everolimus-coated PTCA Catheters. 
x Target lesion must be treated after confirmation that all inclusion criteria 
are met and in absence of any exclusion criteria.  
x Pre-dilation of the target lesion is mandatory. 
x Treatment of the target lesion measuring ≤24 mm in length by visual 
estimation in a vessel of visually estimated diameter ≥2.0mm and 
≤3.5mm. 
x Recommendation is to select a CVT EVE- PTCA Catheter with balloon 
length that allows for coverage of the targeted lesion plus approximately 
2 mm additional coverage, by visual estimate, on each side of the lesion 
while not allowing the balloon length extend beyond the edges of the 
stent. 
x All subjects will be maintained on their routine therapeutic 
anticoagulation treatment or, in the absence of pre-existing treatment, 
will receive a therapeutic daily dose of 75 mg of clopidogrel bisulfate 
(Plavix®) for a minimum of 6 months and aspirin ≥75 mg to be taken 
throughout the length of the clinical investigation following index 
procedure. 

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x All subjects will undergo clinical examination at 6- and 12-months post-
procedure and then will be contacted by phone at 24 and 36 months 
post-procedure to answer a health status questionnaire.  
x A subset of subjects will complete post-procedure angiography (n=25), 
with IVUS (n=15) or OCT (n=10) target vessel assessment, in order to 
compare with the angiographic, IVUS or OCT data obtained at the 6 
month follow-up timepoint. 
Inclusion Criteria 
Study subjects must fulfill the following criteria: 
1. Subject must be at least 18 years of age. 
2. Subject or his/her legally authorized representative provides written 
informed consent prior to any clinical investigation related procedure, 
as approved by the appropriate Ethics Committee of the respective 
clinical site. 
3. Subject must agree to undergo all clinical investigation plan-required 
follow-up visits, angiograms, IVUS/OCT and examinations.  
Angiographic Inclusion Criteria 
1. Target lesion must be located within a stent (bare metal or drug eluting) 
placed in a native epicardial coronary vessel with visually estimated 
nominal vessel diameter of ≥2.0mm and ≤3.5mm. 
2. Target lesion must measure ≤24 mm in length by visual estimation.  
3. The target lesion must be with a visually estimated stenosis of ≥50% 
and < 100% with a TIMI flow of ≥1. 
4. Non-clinical investigation, percutaneous intervention for lesions in a 
non-target vessel is allowed if done ≥90 days prior to or planned to be 
done 6 months after the index procedure. 
5. Non-clinical investigation, percutaneous intervention for lesions in the 
target vessel is allowed if planned to be done 6 months after the index 
procedure. 
Exclusion Criteria 
Subject with any of the following should be excluded: 
1. Subject with known diagnosis of acute myocardial infarction (AMI) 
within 30 days preceding the index procedure and CK-MB or troponin 
have not returned within normal limits at the time of procedure.  
2. The subject is currently experiencing clinical symptoms consistent with 
AMI. 
3. Subject has current unstable arrhythmia. 
4. Subject has a known left ventricular ejection fraction (LVEF) <25%.  
5. Subject has a known hypersensitivity or contraindication to aspirin, 
both heparin and bivalirudin, both clopidogrel and ticlopidine and 
structurally related compounds, everolimus, or contrast sensitivity that 
cannot be adequately pre-medicated. 
6. Subject has known renal insufficiency (e.g., serum creatinine > 2.5 
mg/dL, (i.e. 221 μmol/L) within 7 days prior to index procedure or 
creatinine clearance <30mL/min or subject is on dialysis. 
7. Subject has a history of bleeding diathesis or coagulopathy or will 

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refuse blood transfusions. 
8. Subject has had a cerebrovascular accident (CVA) or transient ischemic 
neurological attack (TIA) within the past six months.  
9. Subject has other medical illness (e.g., cancer or congestive heart 
failure) or known history of substance abuse (alcohol, cocaine, heroin 
etc.) that may cause non-compliance with the clinical investigation 
plan, confound the data interpretation or is associated with a limited life 
expectancy (i.e., less than one year). 
10. Subject is already participating in another clinical investigation that has 
not yet reached its primary endpoint.  
11. Subject is not, in the opinion of the investigator, an acceptable 
candidate to participate in the study. 
12. In-stent lesions for stent are located within an arterial or saphenous vein 
graft or stent used to treat a previous ISR. 
13. The target vessel contains visible thrombus. 
14. Pregnant or lactating females. 
Planned Schedule: 
 
x First subject enrolled:  2021 
x Last subject enrolled:   2022 
x Last subject last contact:  2025 
 
 
 
 
 

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1. 
STUDY OVERVIEW AND RATIONALE 
1.1 Study Overview 
The CVT-ISR study is a prospective, multi-center, open, single arm study which will 
include fifty (50) subjects at up to fifteen (15) sites in Europe and will evaluate the 
clinical safety and efficacy of an everolimus-coated percutaneous transluminal coronary 
angioplasty (PTCA) catheter for the treatment of in-stent restenosis (ISR) in native 
coronary lesions previously treated with drug-eluting stent (DES) or bare-metal stent 
(BMS). 
Study enrollment will be offered to all subjects who are suitable candidates for balloon 
PTCA to correct in-stent restenosis lesions in native coronary arteries. Subjects who fail 
to match the inclusion criteria or who present with any of the exclusion criteria should 
not be included into this study. 
To comply with regulatory requirements, subjects will be required to give written 
informed consent prior to their participation in the study. 
1.2 Background and Literature Review   
Stenting has been shown to be a safe and effective treatment of de novo lesions in native 
coronary arteries through conduct of numerous studies, with first bare-metal stents 
(BMS) 1-9 supplanted by drug-eluting stents (DES).10-18 
Notwithstanding a successful procedure, coronary stents can fail to conserve vessel 
patency due to either in-stent restenosis (ISR) or stent thrombosis (ST),19 a relatively rare 
but serious complication that can cause a large non-fatal myocardial infarction (MI), or 
sudden death.20  ISR, defined as the gradual re-narrowing of a stented coronary artery 
lesion due to arterial damage with subsequent neointimal tissue proliferation,21 remains a 
serious concern as a late stent implant complication. It usually presents as acute coronary 
syndrome in approximately 70 percent of patients but also can present as acute MI in 
approximately 10 percent of patients.22 
The incidence of ISR partly depends on type of stent originally implanted. BMS are 
becoming less commonly used in routine practice23 and DES drastically reduce ISR 
observed with BMS.  Overall, rates of ISR drop under 10 percent23 with DES whereas 
rates range from 17 and 41 percent with BMS.25 However, regardless of the lower ISR 
rate observed, in the field of interventional cardiology, ISR of DES remains a major 
clinical challenge.26, 27 
Various therapies intended to reduce the rate of ISR have been tested in clinical 
investigations and in clinical practice. As a first line of treatment, medication (antiplatelet 
agents, oral sirolimus) did not provide any clinical benefit.28, 29, 30  
Coronary surgery may be considered in patients with recalcitrant ISR, who are deemed to 
not be candidates for percutaneous intervention, particularly in those with a diffuse ISR 
pattern or associated or significant disease in other major vessels.31 
Regarding medical devices, debulking techniques (including rotational atherectomy and 
laser) and cutting balloons have proved to be ineffective for the treatment of ISR.32, 33 
Multiple studies comparing techniques of plain old balloon angioplasty (POBA), bare 
metal stenting, newer generation stenting and brachytherapy have established the 

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superiority of newer generation DES to other percutaneous coronary intervention (PCI) 
devices in treating ISR.34-48 
In the last decade, paclitaxel drug-coated balloon catheters (DCBs) emerged as a 
competitive treatment option for ISR, as demonstrated in a large meta-analysis of 27 
trials with a total of 5923 patients where paclitaxel DCB, among other ISR therapies 
(including POBA, debulking techniques, brachytherapy, BMS, DES), was the second 
most preferable approach to treating ISR but without a significant difference over limus 
therapies or paclitaxel-eluting stents.49  
Despite the large volume of published data, the superiority of the everolimus-eluting 
stents (EES) compared with DCB remains controversial, particularly as the meta-analysis 
discussed above suggests but also because DCBs are currently not available for use in the 
United States51 and no DCB coated with everolimus has been assessed to date to 
evaluated efficacy in treating ISR. 
1.3 Study Rationale 
Whereas the concerning long-term outcomes of paclitaxel-coated DCB catheters have led 
to controversy in the interventional vascular community52-56, CVT has developed a 
possible catheter-based treatment alternative by combining a proven percutaneous 
transluminal coronary angioplasty (PTCA) catheter, designed to treat in-stent restenosis 
in coronary arteries, with a drug-coating using a proven drug, everolimus.  Everolimus is 
an active pharmaceutical agent with a proven history of safety and efficacy for use in 
coronary applications.   
Everolimus [40-O-(2-hydroxyethyl)-rapamycin], is a semisynthetic macrolide 
immunosuppressant, which is in the same family as rapamycin (i.e., the “limus family of 
drugs”) that inhibits mammalian target of rapamycin, and it is known to exert much 
higher interaction with rapamycin complex 2 leading to a blockage of protein synthesis. 
This interaction stops cell cycle progression, inhibits smooth muscle cell proliferation and 
reduces stent restenosis. In addition, everolimus has higher bioavailability and a shorter 
half-life than sirolimus, then it reduces vascular inflammation and stimulates rapid 
endothelialization1. 
Everolimus is a drug widely used in drug-eluting stents (DESs) and is considered as the 
percutaneous treatment of choice for coronary artery disease (CAD).  The safety profile 
of everolimus-eluting stents is well established and the efficacy profile is greater than 
paclitaxel-eluting stents in long-term clinical follow-up2. 
Use of everolimus, a drug with an excellent safety profile and a proven history for 
cardiovascular use, with a proven PTCA catheter was demonstrated in series of pre-
clinical evaluations in swine animal models. Extensive bench and pre-clinical studies 
demonstrated that the CVT Everolimus-coated PTCA Catheter is safe for its intended use 
with no adverse reactions associated to the drug delivery for the stented segment up to 30 
 
1  Trimukhe R, Vani P, Patel A, Salgotra V. Safety and performance of the EverProTM everolimus-eluting coronary stent 
system with biodegradable polymer in a real-world scenario. World J Cardiol. 2020;12(12):615-625. 
doi:10.4330/wjc.v12.i12.615 
2  Meng, M., Gao, B., Wang, X. et al. Long-term clinical outcomes of everolimus-eluting stent versus paclitaxel-eluting stent in 
patients undergoing percutaneous coronary interventions: a meta-analysis. BMC Cardiovasc Disord 16, 34 (2016). 
https://doi.org/10.1186/s1 

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days post-treatment in the animal model. The presence of everolimus in the vessel up to 
30 days post-procedure, as demonstrated in pharmacokinetics studies, was associated 
with the possibility of prevention of restenostic reaction, characterized by signs of drug 
effects in the histopathology studies at that time point in the animal model.
The present trial will confirm the positive evaluations garnered to date of the CVT 
Everolimus- coated PTCA Catheter for its intended use of treating subjects with in-stent
restenosis in native coronary arteries.
2.
DESCRIPTION OF THE STUDY DEVICE
The Chansu Vascular Technologies (CVT) Everolimus-coated PTCA Catheter is a novel 
catheter designed to facilitate percutaneous treatment of subjects with in-stent restenosis in 
coronary arteries.
The CVT Everolimus-coated PTCA Catheter is comprised of two main components: 
1)
2)
2.1
Basic Catheter Specifications
•
•
•
•

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Table 1. CVT Everolimus-coated PTCA Catheter Size Matrix and Total Drug Content
Balloon Diameter 
(mm)
Balloon Length (mm) and Total Drug 
Content (μg)
Nominal dose of everolimus: 
2.2
Indication
The CVT Everolimus-coated PTCA Catheter is intended to be used for improving 
luminal diameter and myocardial perfusion in patients presenting in-stent stenotic lesions 
≤24mm in length in native coronary arteries with reference vessel diameters of 2-3.5mm.
For additional information, refer to the Instructions for Use provided as Appendix E.
3.
STUDY DESIGN
The CVT-ISR Trial investigates the inhibition of restenosis using the CVT Everolimus-coated 
PTCA Catheter in the treatment of in-stent stenotic lesions ≤24 mm in native coronary arteries 
with reference vessel diameters of 2 to 3.5mm. The clinical study will be a prospective, multi-
center, open, single-arm study.
Each subject will be followed for at least 3 years (36 months) after treatment. All subjects will 
have a follow-up contact or an optional office/hospital/clinic visit at 30 days. A follow-up
office/hospital/clinical visit will occur at 6, 12, and a follow up phone call will occur at 24 and 
36 months.
To participate in this study, the site will need the resources necessary for conventional vascular 
surgery as well as for fluoroscopy-guided catheter-based procedures with high quality 
imaging.
The study participation flow chart is provided in Figure 1.

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Pre-Procedure 
Screening: Inclusion/Exclusion Criteria, Subject Signing of Informed Consent 
 
Procedure and Enrollment 
Treatment with CVT Everolimus-Coated PTCA Catheter 
 
Pre-Discharge 
General Assessments 
 
1 Month Follow-up 
Telephone Contact or Office/Hospital/Clinic Visit 
 
6, 12 Month Follow-up  
Office/Hospital/Clinic Visit: General Assessments 
 
24, 36 Month Follow-up  
Phone call 
Figure 1.  CVT-ISR Study Participation Flow Chart 
3.1 Endpoints 
The definitions for the endpoints of this study are taken from the Academic Research 
Consortium-2 Consensus Document, Standardized End Point Definitions for Coronary 
Intervention Trials.3 Regarding the definition for Clinically Relevant Myocardial 
Infarction after Coronary Revascularization, this study adheres to the Expert Consensus 
Document from the Society for Cardiovascular Angiography and Interventions (SCAI)4, 
Consideration of a New Definition of Clinically Relevant Myocardial Infarction after 
Coronary Revascularization. 
3.2 Primary Safety Endpoint 
The primary safety endpoint for the study is freedom from target lesion failure (TLF) rate 
at 6 months post-index procedure, defined as a composite rate of: all cardiac death, target 
vessel myocardial infarction and clinically-driven target lesion revascularization (TLR). 
3.3 Primary Effectiveness Endpoint 
The primary effectiveness endpoint for the study is late lumen loss (LLL) at 180 days 
post procedure.  
3.4 Other Clinical Endpoints 
 
3  Garcia-Garcia HM, McFadden EP, Farb A, et al. Standardized End Point Definitions for Coronary Intervention Trials: The 
Academic Research Consortium-2 Consensus Document. Circulation. 2018;137(24):2635-2650. 
doi:10.1161/CIRCULATIONAHA.117.029289 
4  Moussa ID, Klein LW, Shah B, et al. Consideration of a new definition of clinically relevant myocardial infarction after 
coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions 
(SCAI). J Am Coll Cardiol. 2013;62(17):1563-1570. doi:10.1016/j.jacc.2013.08.720 

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• 
Target lesion failure (TLF) at 30 days, 1, 2 and 3 years, post-procedure, defined as a 
composite rate of cardiovascular death, target vessel myocardial infarction and 
clinically-driven target lesion revascularization (TLR). 
• 
Target vessel failure (TVF) at 30 days, 180 days and 1, 2 and 3 years post-procedure, 
defined as a composite rate of cardiovascular death, target vessel myocardial infarction, 
and target vessel revascularization (TVR). 
• 
Clinically-driven target lesion revascularization (TLR) at 1, 2 and 3 years post-
procedure. 
• 
Clinically-driven target vessel revascularization (TVR) at 180 days and 1, 2 and 3 years 
post-procedure. 
• 
Rate of vascular access site complication, defined as the combined rate of hematoma, 
AV fistula or a pseudoaneurysm that required intervention, such as surgical repair or 
transfusion, prolonged hospital stay or required a new hospital admission. 
• 
Lesion success (per device), defined as achievement of a final in-lesion residual 
diameter stenosis of <30% (by QCA), using any device after wire passage through the 
lesion. Pre- and post-dilatation of the lesion with a non-study device is considered part 
of assigned device treatment. 
• 
Technical success (per device), defined as achievement of a final in-lesion residual 
diameter stenosis of <30% (by QCA), using the CVT Everolimus-coated PTCA 
Catheter without a device malfunction after wire passage through the lesion. Pre- and 
post-dilatation are considered part of assigned device treatment. 
• 
Clinical success (per subject) defined as technical success without the occurrence of 
major adverse events during the procedure. 
• 
Procedural success (per subject) defined as lesion success without the occurrence of 
major adverse events during the procedure. 
3.5 Angio-IVUS-OCT Endpoints 
Angiographic endpoints: 
• 
In-segment LLL at 180 days 
• 
In-stent and in-segment % diameter stenosis (%DS) at 180 days 
• 
In-stent and in-segment angiographic binary restenosis (ABR) rate at 180 days 
IVUS endpoint: 
• 
In-stent % volume obstruction (%VO) at 180 days 
OCT endpoints: 
• 
% of stent strut coverage at 180 days 
3.6 Study Population 
Subjects included in this study will be comprised of male and female subjects derived 
from the general interventional cardiology population. This study will include fifty (50) 
subjects with a with a single in-stent stenotic lesion in a native coronary artery, eligible to 
be treated by interventional therapy and who meet all the inclusion criteria and none of 

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the exclusion criteria of this study. 
3.7 Ethical Considerations 
The trial will be conducted in accordance with this Clinical Investigational Plan (CIP), 
the Declaration of Helsinki, BS EN ISO 14155:2020 standards and Good Clinical 
Practices. The conduct of the trial will be approved by the appropriate Medical Ethics 
Committee (MEC) of the respective clinical site and as specified by local and country 
specific regulations. 
3.8 Subject Inclusion Criteria 
Study subjects must fulfill the following clinical criteria: 
1. Subject must be at least 18 years of age. 
2. Subject or his/her legally authorized representative provides written informed consent 
prior to any clinical investigation related procedure, as approved by the appropriate 
Ethics Committee of the respective clinical site 
3. Subject must agree to undergo all clinical investigation plan-required follow-up visits, 
angiograms, IVUS/OCT and examinations.  
Angiographic Inclusion Criteria 
1. Target lesion must be located within a stent placed in a native epicardial coronary 
vessel with visually estimated nominal vessel diameter of ≥2.0mm and ≤3.5mm. 
The previously implanted stent can be bare metal or a drug eluting stent. 
2. Target lesion must measure ≤24 mm in length by visual estimation.  
3. The target lesion must be with a visually estimated stenosis of ≥ 0% and <100% 
with a TIMI flow of ≥1. 
4. Non-clinical investigation, percutaneous intervention for lesions in a non-target 
vessel is allowed if done ≥90 days prior to or if planned to be done 6 months after 
the index procedure. 
5. Non-clinical investigation, percutaneous intervention for lesions in the target vessel 
is allowed if planned to be done 6 months after the index procedure. 
3.9 Subject Exclusion Criteria 
Subjects with any of the following criteria should be excluded: 
1. Subject with known diagnosis of acute myocardial infarction (AMI) within 30 days 
preceding the index procedure and CK-MB and troponin have not returned within 
normal limits at the time of procedure.  
2. The subject is currently experiencing clinical symptoms consistent with AMI. 
3. Subject has current unstable arrhythmia. 
4. Subject has a known left ventricular ejection fraction (LVEF) <25%.  
5. Subject has a known hypersensitivity or contraindication to aspirin, both heparin and 
bivalirudin, both clopidogrel and ticlopidine and structurally related compounds, 
everolimus or contrast sensitivity that cannot be adequately pre-medicated. 

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6. Subject has known renal insufficiency (e.g., serum creatinine level of more than 2.5 
mg/dL, (i.e. 221 μmol/L) within 7 days prior to index procedure or subject on dialysis. 
7. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood 
transfusions. 
8. Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological 
attack (TIA) within the past six months. 
9. Subject has other medical illness (e.g., cancer or congestive heart failure) or known 
history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-
compliance with the clinical investigation plan, confound the data interpretation or is 
associated with a limited life expectancy (i.e., less than one year). 
10. Subject is already participating in another clinical investigation that has not yet reached 
its primary endpoint.  
11. Subject is not in the opinion of the investigator an acceptable candidate to participate in 
the study. 
12. In stent lesions for stent are located within an arterial or saphenous vein graft.  
13. The target vessel contains visible thrombus. 
 Pregnant or lactating females.
3.10 Subject Enrollment Point 
All subjects who are candidates for treatment of in-stent restenosis in coronary arteries 
will undergo screening for study eligibility and, if applicable, for study enrollment. For 
any subject enrolled, a signature of informed consent will be obtained. The subject will 
be considered enrolled into the study upon the completion of all the following: 
x A signed subject informed consent.
x Angiographic criteria for enrollment has been met.
x Target lesion is successfully crossed by the guidewire.
x Successful pre-treatment of in-stent restenosis without complication, if applicable.
x CVT Everolimus-coated PTCA Catheter has entered the vasculature.
3.11 Subject Discontinuation 
Every subject should remain in the trial until completion of the required follow-up 
period; however, a subject’s participation in any clinical trial is voluntary and the subject 
has the right to withdraw at any time without penalty or loss of benefit. The reason for 
withdrawal, when it occurs, must be documented in the subject’s medical records. 
Following study discontinuation, the subject will be followed per the institution’s 
standard of care. Conceivable reasons for discontinuation may include, but are not limited 
to, the following: 
x Subject participation in a clinical trial is voluntary and the subject may discontinue 
participation (refuse all subsequent testing/follow-up) at any time.
x Investigator may terminate the subject’s participation without regard to the subject’s 
consent if the Investigator believes discontinuation in the study is medically necessary.

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x Subject does not complete the scheduled follow-up but has not ‘officially’ withdrawn 
from the trial (e.g. “lost to follow-up”). This does not apply to missed visits.
x Medical conditions such as the following
o Reaction to acute treatment requires alternative treatment or intervention (e.g. 
allergic reaction to everolimus, complication with non-study device) where study 
objectives cannot be objectively evaluated. 
o Unanticipated hospitalization requiring treatment or therapy conflictive with 
study objectives and preventing compliance with study requirements. 
Site personnel should make all reasonable efforts to locate and communicate with 
subjects at each contact time point. A minimum of two (2) telephone calls to contact the 
subject should be recorded in the source documents, including date, time, and initials of 
site personnel trying to make contact. If these attempts are unsuccessful, a letter should 
be sent to the subject. If the subject misses two (2) consecutive scheduled contact time 
points and the above mentioned attempts at communicating with the subject are 
attempted but unsuccessful, the subject will be considered “lost to follow-up”. 
A study completion form must be completed when a) the subject is considered “lost to 
follow- up” (per the above criteria), b) the subject withdraws from the study or c) the 
investigator withdraws the subject from the study. In each case of subject 
discontinuation, CVT must be notified of the reason for subject discontinuation. The site 
will provide this information on the case report form (CRF) and in source documents. 
3.12 Early Termination of the Clinical Trial 
CVT, the trial Sponsor, reserves the right to discontinue the clinical study at any stage, 
with suitable written notice to the investigator. The investigator may also discontinue 
participation in the clinical trial with suitable written notice to CVT. 
CVT and the Study Steering Committee will monitor the progression of the study. The 
study will be suspended or discontinued early if there is an observation of serious adverse 
reactions presenting an unreasonable risk to the study population.  
Notification of suspension or termination will occur no later than five (5) working days 
after Sponsor makes the determination. In the event of study suspension or termination, 
the Sponsor will send a report outlining the circumstances to the IRB/EC and all 
investigators. A suspended or terminated study may not be re-initiated without approval 
of the reviewing IRB/EC (where applicable).  
4. 
CONDUCT OF THE STUDY 
Study conduct as well as detail of pre-procedure, procedural, discharge and follow up activities are 
presented in this section of the protocol.  Refer to Table 3 for a summary of pre-procedure, 
procedure, discharge and follow up activities. 
 
 

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4.1 Baseline Assessments 
Subject preparation will occur in accordance with standard hospital policy for the care of 
interventional endovascular subjects. Baseline assessments will be documented in the 
subject medical record and on the case report form (CRF) as appropriate. 
Subject History 
Subject history will include but not be limited to the following risk factors and co-
morbidities: age, height, weight, body mass index (BMI), gender, hypertension, 
hyperlipidemia, diabetes mellitus, smoking, ischemic heart disease (history of myocardial 
infarction, angina pectoris, previous percutaneous or surgical coronary revascularization), 
history of peripheral vascular disease (previous percutaneous or surgical 
revascularization), deep vein thrombosis, congestive heart failure, renal insufficiency, 
renal disease, liver disease, cerebrovascular disease (known carotid artery disease, history 
of minor or major stroke or transient ischemic attack), and chronic obstructive pulmonary 
disease (COPD). 
Medication History 
A medication history should be documented which includes chronic concomitant 
medications and protocol required medications. 
Clinical Assessments 
A physical examination should be documented.  The exam will include heart rate, blood 
pressure and body temperature. 
Laboratory Assessments 
A pregnancy test should be administered to all female subjects of childbearing potential 
within 14 days prior to the procedure. 
The following laboratory tests should be obtained for all subjects within 7 days prior to 
the index procedure. 
x Complete Blood Count  
x Creatinine  
x Absolute Platelet Count 
x Coagulation tests as per standard of care of the hospital (e.g., Prothrombin Time (PT) 
and activated Prothrombin Time (aPTT). 
The following laboratory tests should be obtained for all subjects within 72 hours of the 
index procedure. 
x CK and/or CK-MB and cardiac troponin (cTn) 
x 12 lead ECG. 
4.2 Concomitant Medical Therapy 
Antiplatelet medication should be administered according to hospital routine and in line 
with the applicable guidelines on Percutaneous Coronary Interventions and the 
Instructions for Use of the device. 
All subjects will receive aspirin (a minimum of 75 mg daily, within 24 hours prior to the 
procedure) and a loading dose of any approved antiplatelet medication within 24 hours 

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prior to the procedure or immediately post procedure (within 30 minutes of last catheter 
removal). If the subject already has taken an appropriate dose of anti-platelet medication 
within 72 hours prior to the procedure, no loading dose is required. 
During the index procedure, heparin or bivalirudin may be administered as per hospital 
standard of care to maintain adequate anticoagulation. 
A GP IIb/IIIa receptor blocker may be administered at the Investigator’s discretion. 
Following the procedure, subjects will receive a minimum of 75 mg of aspirin daily 
indefinitely and an appropriate dose of any approved anti-platelet medication for a 
minimum of 6 months in all subjects or longer per the ACC/AHA/SCAI guidelines5 and 
with the Investigator’s discretion. 
All antiplatelet/anticoagulant medications will be documented on the CRF from 24 hours pre-
procedure through the 36-month follow-up assessment. 
Table 2 summarizes the study required regimen for antiplatelet medication for subjects 
enrolled in the study prior and during procedure.  
Table 2. CVT-ISR Study Required Antiplatelet Medication Regimen 
Time Point 
Medication 
Regimen 
Prior to 
Procedure 
Heparin or bivalirudin 
As needed 
Aspirin 
A minimum of 75 mg daily (within 24 
hours  prior to procedure) 
Clopidogrel/Plavix, 
Prasugrel/Effient, 
Ticagrelor/Brilinta, or 
Ticlopidine/Ticlid or any market 
approved antiplatelet indicated. 
Loading dose within 24 hours prior to 
procedure or immediately post 
procedure (within 30 minutes of last 
catheter removal) 
 
No loading dose is required if the subject  
has taken at least 3 maintenance doses 
within 72 hours prior to the procedure 
During 
Procedure 
Heparin or bivalirudin 
To maintain adequate anticoagulation 
per hospital standard of care 
GP IIb/IIIa receptor blocker 
Use at Investigator’s discretion 
Post-
Aspirin 
A minimum of 75 mg daily indefinitely 
 
5   Levine GN, Bates ER, Bittl JA, et al. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in 
Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task 
Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary 
Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 
ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic 
Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC 
Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA 
Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery [published 
correction appears in Circulation. 2016 Sep 6;134(10):e192-4]. Circulation. 2016;134(10):e123-e155. 

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Procedure 
Clopidogrel/Plavix, 
Prasugrel/Effient, 
Ticagrelor/Brilinta or 
Ticlopidine/Ticlid or any market 
approved antiplatelet indicated 
A minimum of 6 months in all subjects, 
or longer as according to appropriate 
guidelines and upon Investigator’s 
discretion 
 
4.3 ISR PTCA Procedure 
Procedural Medications 
During the procedure, the subjects will receive appropriate anticoagulation and other 
therapy according to standard hospital practice. The use of any medication for the 
treatment of vessel spasm, subject agitation or discomfort, hypotension, arrhythmias and 
hemodynamic changes during the procedure is at the discretion of the investigator. 
Treatment Strategy 
The treatment strategy for all subjects enrolled in the clinical investigation is as follows: 
x Treatment of a single in-stent restenosis lesion in a native coronary artery with up to 
two (2) CVT Everolimus-coated PTCA Catheters. 
x Target lesion must be treated after meeting all the general and angiographic 
inclusion and exclusion criteria. 
x Pre-dilation of target lesion is mandatory. 
x Treatment of target lesion measuring ≤24 mm in length by visual estimation in 
vessel of visually estimated diameter ≥2.0mm and ≤3.5mm.  
x Recommendation is to select a CVT EVE-PTCA Catheter with a balloon length that 
allows for coverage of the targeted lesion plus approximately 2 mm additional 
coverage, by visual estimate, on each side of the lesion while not allowing the 
balloon length extend beyond the edges of the stent. 
PTCA Procedure 
Vascular access should be obtained as per site standard of care (depending on lesion 
location, subject factors or any other factors that would impact the choice of vascular 
access). 
Angiography must be conducted according to the angiographic core laboratory 
guidelines. 
As a next step, a compatible sheath should be inserted and anticoagulation should be 
administered as per the Investigator’s discretion to obtain or maintain appropriate clotting 
time (reference section 4.2. Concomitant Medical Therapy). In order to identify the 
anatomical characteristics of the vasculature and to visualize and define the lesion, 
selective angiography will be performed. Following angiography, the appropriate catheter 
size(s) will be selected. 
Pre-dilatation will be performed on all subjects per the following sequence: after crossing 
of the target lesion with a guidewire, pre-dilatation is performed with a non-study balloon 
catheter, making sure that the balloon length is shorter than previously placed stent 

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length. Note that the use of a non-drug coated standard semi-compliant balloon or 
cutting/scoring balloon is allowed. 
Record an image of the target lesion after pre-dilatation is completed. Ensure to perform 
an angiography distal to the target lesion. Assess the subject for any angiographic 
complications after pre-dilatation and confirm the lesion to be treated meets the study 
angiographic inclusion and exclusion criteria. 
Successful pre-dilatation of the target lesion is defined as: 
x Residual stenosis of <30% after pre-dilatation (per visual estimate) AND 
x 
No major (>Grade B) flow-limiting dissection. 
In case of unsuccessful pre-dilatation of the target lesion planned to be treated with the 
investigational device, the subject should be considered a screen failure and all lesions 
should be treated as per standard of care. 
Treatment with CVT Everolimus-coated Catheter 
It is recommended to select a CVT EVE-PTCA Catheter with a balloon length that allows 
for coverage of the targeted lesion plus approximately 2 mm additional coverage, by visual 
estimate, on each side of the lesion while not allowing the balloon length extend beyond 
the edges of the stent. 
The balloon should be inflated for 60 seconds in order to allow for an optimal drug delivery 
to the surrounding tissue. 
Post-Procedure Angiography Subset 
A subset of twenty-five (25) subjects will complete post-procedure angiography 
assessment of the target vessel, as per the angiographic core laboratory guidelines, at 6 
months post-procedure.  
The 25 subjects undergoing angiographic follow up will represent the first subjects 
enrolled into the study, with no more than 15 patients undergoing angiographic follow up 
from a single site.  
Note: The end of the procedure is defined as the time after a complete final angiogram 
has been performed and the last guidewire and catheter have been removed. In case the 
subject needs to return to the procedure room and a guiding catheter is reinserted for 
dilatation, this is considered a reintervention. Removal of the sheath(s) may be done at 
the Investigators discretion. 
All catheters, including the CVT Everolimus-coated PTCA Catheter, should be delivered 
and deployed per their respective Instructions for Use (reference Appendix E for CVT 
Everolimus-coated PTCA Catheter IFU). All balloon inflations should be captured per 
the angiographic core laboratory guidelines. 
Intravascular Ultrasound Examination (IVUS) 
A subset of fifteen (15) subjects will complete an intravascular ultrasound (IVUS) 
examination at both the index procedure and at 6 months post-procedure, as per the IVUS 
core lab guidelines. 
The 15 subjects undergoing IVUS examination will represent the first patients enrolled 

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into the study. 
Note: The end of the procedure is defined as the time after a complete final angiogram 
has been performed and the last guidewire and catheter have been removed. In case the 
subject needs to return to the procedure room and a guiding catheter is reinserted for 
dilatation, this is considered a reintervention. Removal of the sheath(s) may be done at 
the Investigators discretion. 
All catheters, including the CVT Everolimus-coated PTCA Catheter, should be delivered 
and deployed per their respective Instructions for Use (reference Appendix E for CVT 
Everolimus-coated PTCA Catheter IFU). All balloon inflations should be captured per 
the core laboratory guidelines. 
Optical Coherence Tomography (OCT) 
A subset of ten (10) subjects will complete optical coherence tomography (OCT) imaging 
at both the index procedure and at 6 months post-procedure, as per the OCT core lab 
guidelines. 
The 10 subjects undergoing OCT examination will represent the first subjects enrolled 
into the study undergoing angiographic follow up and not undergoing IVUS examination.  
Note: The end of the procedure is defined as the time after a complete final angiogram 
has been performed and the last guidewire and catheter have been removed. In case the 
subject needs to return to the procedure room and a guiding catheter is reinserted for 
dilatation, this is considered a reintervention. Removal of the sheath(s) may be done at 
the Investigators discretion. 
All catheters, including the CVT Everolimus-coated PTCA Catheter, should be delivered 
and deployed per their respective Instructions for Use (reference Appendix E for CVT 
Everolimus-coated PTCA Catheter IFU). All balloon inflations should be captured per 
the angiographic core laboratory guidelines. 
Criteria for Bail-Out or Alternative Procedures 
Adjunctive therapies should be avoided if possible. In case of suboptimal procedure 
results (>50 % residual stenosis, perforation, occlusive complication (recoil) or flow 
limiting dissection) prolonged balloon inflation should be attempted. If a subject in this 
study experiences a major dissection or an occlusive complication (as evidenced by 
decreased target vessel flow, chest pain, or ischemic electrocardiogram (ECG) changes 
which do not respond to standard rescue techniques), bailout stenting procedures may be 
performed. All other adjunctive therapies (including but not limited to: laser, 
atherectomy, cryoplasty or brachytherapy) are not allowed. 
If bailout procedures are performed, justification should be documented on the CRF. 
Subjects undergoing bailout procedures will continue in the study and their data will 
remain part of the statistical analyses. 
 
 

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4.4 Post-Procedure Subject Management 
Following the procedure, the subject will be treated in accordance with the hospital 
standard of care for PTCA interventions. 
Sheath Removal and Ambulation 
Use of approved vascular closure devices are allowed, provided the device is used 
according to the manufacturer’s IFU and the operator has been properly trained in the 
device use. The subject may be ambulated according to hospital standards after 
hemostasis of the access site is achieved. 
Medications 
All subjects will be maintained on their routine therapeutic anticoagulation treatment or, 
in the absence of pre-existing treatment, subjects will receive a therapeutic daily dose of 
75 mg of clopidogrel bisulfate (Plavix®) for a minimum of 6 months and aspirin ≥75 mg 
to be taken throughout the length of the clinical investigation following index procedure. 
If a subject develops hypersensitivity to clopidogrel bisulfate, they may be switched to 
ticlopidine hydrochloride at a dose in accordance with standard hospital practice. 
Note: Subjects receiving ticlopidine hydrochloride must have a complete blood cell count 
(CBC) and differential blood count done per the IFU for ticlopidine hydrochloride. 
4.5 Pre-Discharge Assessments 
Medication History 
The medication history should be updated as needed to include modifications to the 
chronic concomitant medications and protocol required medications. 
Laboratory Tests 
x Complete Blood Count  
x Absolute Platelet Count 
x Coagulation tests as per standard of care of the hospital (e.g., Prothrombin Time (PT) 
and activated Prothrombin Time (aPTT). 
Cardiac Tests 
x CK and/or CK-MB and cardiac troponin (cTn) 
x 12 lead ECG 
4.6 Subject Follow-up Post Hospital Discharge 
Following hospital discharge, subjects will be followed at pre-determined time points 
during the study. 
Subject Contact at 1 month (30 ± 7 days) 
Subjects will be contacted at 30 days post hospital discharge via phone call for 
assessment of overall condition, medications, physical questionnaire and adverse events. 
Alternatively, this contact can be performed in a site visit and include a physical 
examination.  The physical questionnaire will include the following: arterial access site 
status, heart rate abnormalities, presence of elevated temperature, clinical events that 

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required a doctor’s visit or hospital admission. 
Subject Clinical Visit at 6 months (180 ±30 days) according to the following sequence 
x Physical examination 
x 12 lead ECG 
x Concomitant medication (name, dose, duration) 
x Adverse event assessment 
x Data regarding any emergent treatment and or serious adverse events and/or need for 
repeat angiography or interventions, and results of such if applicable 
x Angiographic, IVUS or OCT follow-up per core laboratory guidelines for the subset of 
25 subjects that has undergone these imaging procedures at index procedure. 
Subject Clinical Visit at 12 months (365 ±30 days) 
x Physical examination 
x 12 lead ECG 
x Concomitant medication (name, dose, duration) 
x Adverse event assessment 
x Data regarding any emergent treatment and or serious adverse events and/or need for 
repeat angiography or interventions, and results of such if applicable. 
Subject Phone call follow up at 24 Months (730 ± 30 days) 
Subjects will be contacted at 24 months post hospital discharge via phone call for 
assessment of overall condition, physical questionnaire and medications. Alternatively, 
this contact can be performed in clinical visit with the referring physician. 
Subject Phone call follow up at 36 Months (1095 ± 30 days) 
Subjects will be contacted at 36 months post hospital discharge via phone call for 
assessment of overall condition, physical questionnaire and medications. Alternatively, 
this contact can be performed in clinical visit with the referring physician. 
 
 

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Table 3. CVT-ISR Study Pre-Procedure, Procedural, Discharge and Follow Up Activities 
PROCEDURE/TEST 
Prior to 
Procedure 
Pre-Procedure 
Procedure 
Pre-Discharge 
30 days 
(± 7 days) 
180 days 
(± 30 days) 
1 year 
(± 30 days) 
2 years 
(± 28 days) 
3 years 
(± 30 days) 
Patient Medical History 
X 
 
 
 
 
 
 
 
 
Review 
Inclusion/Exclusion 
Criteria5 
X 
 
 
 
 
 
 
 
 
Patient Informed Consent 
X 
 
 
 
 
 
 
 
 
Chronic Concomitant 
Medications/History 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Creatinine 
X 
 
 
 
 
 
 
 
 
CBC, Platelet Count 
X 
 
 
X 
 
 
 
 
 
Coagulation Tests 
X 
 
 
X 
 
 
 
 
 
Pregnancy Test (if 
applicable) 
X 
 
 
 
 
 
 
 
 
CK-Mb 
 
X 
 
X 
 
 
 
 
 
Cardiac Troponin (cTn) 
 
X 
 
X 
 
 
 
 
 
12 Lead ECG3 
 
X 
 
X 
 
X 
X 
 
 
Coronary angiogram 
 
 
X1 
 
 
X2 
 
 
 
IVUS 
 
 
X6 
 
 
X6 
 
 
 
OCT 
 
 
X7 
 
 
X7 
 
 
 
Physical Examination 
X 
 
 
 
X8 
X 
X 
 
 
Per-protocol medications 
 
X 
X 
X 
X 
X 
X 
X 
X 
Physical status q’naire  
 
 
 
 
X8 
 
 
X 
X 
Adverse events4 
 
 
X 
X 
X 
X 
X 
X 
X 
1  Prior to and immediately post in-stent treatment with CVT Everolimus-coated PTCA Catheter. 
2  
In a subset of 25 patients at both index procedure and 180 day follow up  
3  
A 12 lead ECG will be performed within 24 hours post-procedure. Relevant copies of ECGs will be collected for death or 
any (suspected) myocardial infarction or (suspected) stent thrombosis that occurs after the index procedure for adjudication 
purposes by a Clinical Events Committee (CEC). This includes copies of the baseline ECG (screening and discharge) and 
event ECG (most abnormal ECG and last ECG recorded) if available. 
4  
AE collection will start when CVT Everolimus-coated PTCA Catheter has entered the vasculature. 
5  
A log of patients presenting to sites with in-stent restenosis be maintained and provide reasons for not including subjects in 
the study. 
6. 
In a subset of 15 subjects at both index procedure and 180 day follow up 
7. In a subset of 10 subjects at both index procedure and 180 day follow up 
8.  Depending on if the 30 day follow up is an office visit (exam) or phone call (questionnaire) 

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5. 
ADVERSE EVENTS 
5.1 Adverse Events 
At each evaluation, the investigator will determine whether any adverse events (AEs) 
have occurred. For the purpose of this protocol, an adverse event is any untoward 
medical occurrence, unintended disease or injury, or untoward clinical signs (including 
laboratory findings) in subjects, users or other person, whether or not related to the 
investigational medical device. 
In this study, subjects should be encouraged to report AEs spontaneously or in response 
to general, non-directed questioning. If it is determined that an AE has occurred, the 
investigator should obtain all the information required to complete the AE Form of the 
CRF. 
In addition, subjects will be instructed to contact the investigator, and/or study 
coordinator if any significant adverse events (e.g., MACE) occur between study 
evaluation visits. 
AE collection will start when CVT Everolimus-coated PTCA Catheter has entered the 
vasculature. 
Adverse events should be followed to resolution or stabilization, and if an ongoing AE 
changes in severity, a new AE entry for this event should be recorded. If a mild adverse 
event changes to a moderate or severe adverse event, the end date for the mild event and 
the start date for the moderate or severe event should be the same. Additionally, the mild 
event is considered resolved with the initiation of the moderate or severe event. 
Adverse events that are present at the end of a subject’s participation in the study should 
be marked as on-going on the case report form and the subject should receive post-
treatment follow-up as appropriate. 
5.2 Anticipated Adverse Events 
An anticipated adverse event is any untoward medical occurrence in a subject that is 
predefined in the protocol and/or Instruction for Use (IFU) and that is identified or 
worsens during a clinical study, regardless whether or not the event is considered related 
to the study device or drug regimen prescribed as part of the protocol. 
The following is a list of adverse events that may result from the PTCA procedure.  
x Acute myocardial Infarction (Cardiac) 
x Aneurysm 
x Arrhythmias, including ventricular fibrillation (bradycardia & tachycardia)  
x Arterial Dissection 
x Arteriovenous fistula  
x Bleeding 
x Coronary artery spasm  
x Coronary artery thrombosis 
x Death (Cardiovascular or non-cardiovascular related)  
x Discomfort during procedure 

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x Drug reactions or allergic reactions to contrast medium  
x Distal Embolism (air, thrombus, plaque)/Device Embolism 
x Endocarditis 
x Fever 
x Groin bruising/discomfort 
x Hematoma  
x Hemorrhage 
x Hypotension/hypertension  
x Injury at blood vessel access site requiring surgical or medical treatment 
x Ischemia 
x Pseudoaneurysm  
x Renal failure 
x Restenosis of the dilated vessel  
x Sepsis, infection 
x Stroke or cerebrovascular event  
x Total occlusion of the coronary artery or bypass graft  
x Unstable angina  
x Vessel dissection, perforation, rupture or injury  
x Thrombosis 
x Vomiting/Nausea 
The oral formulation of everolimus has been evaluated in clinical trials and is approved 
worldwide for the prophylaxis of organ rejection in adult kidney transplant recipients at low-
moderate immunologic risk and for the treatment of patients with advanced renal cell 
carcinoma. Oral dose of everolimus depending on the indication ranges between 1.5 and 20 
mg/day. The following list includes the known risks of everolimus at these oral doses. 
The following is a list of theoretical adverse events that may result from the addition of 
everolimus to a PTCA catheter: 
x Abdominal pain  
x Anemia 
x Angioedema 
x Anorexia 
x Asthenia 
x Constipation 
x Cough 
x Delayed wound healing/fluid accumulation 
x Diarrhea 
x Dyslipidemia (including hyperlipidemia and hypercholesterolemia) 
x Dyspnea 
x Dysgeusia 
x Dyspepsia 

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x Dysuria 
x Dry skin 
x Edema (peripheral) 
x Epistaxis 
x Fatigue 
x Headache 
x Hematuria 
x Hyperglycemia  
x Hyperlipidemia 
x Hyperkalemia 
x Hypertension 
x Hypokalemia 
x Hypomagnesemia 
x Hypophosphatemia 
x Increased serum creatinine 
x Infections and serious infections: bacterial, viral, fungal, and protozoal infections 
x Insomnia 
x Interaction with strong inhibitors and inducers of CYP3A4 or PgP 
x Leukopenia 
x Lymphoma and other malignancies (including skin cancer) 
x Male infertility  
x Mucosal inflammation (including oral ulceration and oral mucositis) 
x Nausea 
x Neutropenia 
x Non-infectious pneumonitis 
x Pain: extremity, incision site and procedural, and back 
x Proteinuria 
x Pruritus 
x Pyrexia 
x Rash 
x Stomatitis 
x Thrombocytopenia 
x Thrombotic microangiopathy  
x Thrombotic thrombocytopenic purpura 
x Tremor 
x Urinary tract infection 
x Upper respiratory tract infection 
 Vomiting 
The following is a list of adverse events that may result from the follow-up angiography 

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procedures: 
x Acute myocardial Infarction  
x Arrhythmias, including ventricular fibrillation (bradycardia & tachycardia)  
x Arteriovenous fistula  
x Coronary artery spasm  
x Death (Cardiovascular or non-cardiovascular related)  
x Drug reactions or allergic reactions to contrast medium  
x Hematoma (Access Site Complication or Bleeding) 
x Hypotension/hypertension  
x Infection (Access Site Complication) 
x Pain and tenderness  
x Pseudoaneurysm  
x Restenosis of the dilated vessel  
x Stroke, air embolism, and embolization or fragmentation of thrombotic or 
atherosclerotic material (Neurologic) 
x Total occlusion of the coronary artery or bypass graft  
x Unstable angina  
x Vessel dissection, perforation, rupture or injury  
5.3 Adverse Event Severity 
The investigator will use the following definitions to rate the severity of each adverse 
event: 
Mild 
Awareness of a sign or symptom that does not interfere with the 
subject’s usual activity or is transient, resolved without treatment and 
with no sequelae 
Moderate 
Interferes with the subject’s usual activity and/or requires symptomatic 
treatment 
Severe 
Symptom(s) causing severe discomfort and significant impact of the 
subject’s usual activity and requires treatment 
5.4 Relationship to Study Device 
The investigator will use the following definitions to assess the relationship of the 
adverse event to the use of study device: 
 
 

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Not Related 
Relationship to the device or procedures can be excluded when: 
x The event has no temporal relationship with the use of the 
investigational device or the procedures related to the 
application of the investigational device. 
x The serious adverse event does not follow a known response 
pattern and is biologically impossible. 
x The discontinuation of medical device application or the 
reduction of the level or activation/exposure, when clinically 
feasible, and the re-introduction of its use do not impact on 
the serious adverse event. 
x The event involves a body-site or an organ that cannot be 
affected by the device or procedure. 
x The serious adverse event can be attributed to another cause 
(e.g. an underlying or concurrent illness/clinical condition, 
an effect of another device/drug/treatment, or other risk 
factors). 
x The event does not depend on a false result given by the 
investigational device used for diagnosis, when applicable. 
Possible 
The relationship with the use of the investigational device or the 
relationship with procedures is weak but cannot be ruled out 
completely.  Alternative causes are also possible (e.g. an 
underlying or concurrent illness/clinical condition, an effect of 
another device/drug/treatment). Cases where relatedness cannot 
be assessed, or no information has been obtained, should be also 
be classified as possible. 
Probable 
The relationship with the investigational device or the relationship 
with the procedures seems relevant and/or the event cannot be 
reasonably explained by another cause. 
Highly 
Probable 
 The serious adverse event is associated with the investigational 
device or with procedures beyond reasonable doubt when: 
x The event is a known side effect of the product category 
the device belongs to or of similar devices and procedures. 
x The event has a temporal relationship with the 
investigational device use/application or procedures. 
x The event involves a body-site or organ that a) the 
investigational device or procedures are applied to or b) 
the investigational device or procedures have an effect on. 
x The serious adverse event follows a known response 
pattern to the medical device. 
x The discontinuation of the medical device application (or 
reduction of the level of activation/exposure) and 
reintroduction of its use (or increase in the level of 
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(when clinically feasible). 
x Other possible causes (e.g. an underlying or concurrent 
illness/critical condition or/and an effect of another 
device, drug or treatment) have been adequately ruled out 
x Harm to the subject is due to error in use. 
x The event depends on a false result given by the 
investigational device used for diagnosis, when applicable. 
5.5 Serious Adverse Events 
An Adverse Event is considered serious if the event led, or might have led, to one of the 
following outcomes: 
x Death of a subject 
x Serious deterioration in the health of a subject that resulted in any of the following: 
o Life-threatening illness or injury 
o Permanent impairment of a body structure or body function 
o Hospitalization or prolongation of patient hospitalization 
o Medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or body function  
o Chronic disease 
x Foetal distress, foetal death or a congenital physical or mental impairment or birth 
defect 
Planned hospitalizations for pre-existing conditions or a procedure required by this 
protocol without serious deterioration in health is not considered a serious adverse event. 
5.6 Procedures for Reporting Serious Adverse Event 
Criteria for Reporting Serious Adverse Event 
Serious adverse events are required to be reported for the following situations: 
a. Any serious adverse event that has a causal relationship with the investigational 
device or the investigation procedure or where such as causal relationship is 
reasonably possible. 
b. Any device deficiency that might have led to a serious adverse event if appropriate 
action had not been taken, intervention had not occurred or circumstances had been 
less fortunate. 
c. Any new findings in relation to any event referred to in points (a) and (b) above. 
Reporting by the Sponsor to National Competent Authorities 
The Sponsor must report serious adverse events to the National Competent Authorities 
(NCAs) where the clinical investigation has commenced per the following timelines: 
x For all reportable events which indicate an imminent risk of death, serious injury 
or serious illness and that requires prompt remedial action for other subjects, users 

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or other persons or a new finding to the event: Immediately but not later than two 
(2) calendar days after awareness by the Sponsor of a new reportable event or of 
new information in relation with an already reported event. 
x For other reportable events or a new finding/update: Immediately but not later 
than seven (7) calendar days following the date of awareness by the sponsor of the 
new reportable event or of new information in relation with an already report 
event. 
Reporting by the Clinical Trial Investigator to Sponsor 
The Clinical Trial Investigator will report to the Sponsor immediately but no later than 
three (3) calendar days after investigational site study personnel become aware of the 
event. 
Risk Assessment 
In conjunction with the Coordinating Clinical Investigator and/or, if need be, the Clinical 
Event Committee (section 10.2) the Sponsor shall decide whether, as a result of a serious 
adverse event, the safety of study participants is at risk, or whether continuation of the 
trial is in jeopardy.  
Corrective Measures 
If any situation potentially jeopardizing the safety of subjects, users or third persons arise 
during a clinical trial or approved performance evaluation, then the Sponsor and those 
persons carrying out the clinical trial or the performance evaluation shall immediately 
take all of the essential safety measures in order to protect subjects, users or third persons 
from direct or indirect danger. The Sponsor or his representative shall immediately 
inform the competent Authority and arrange for the competent Ethics Committee to be 
informed of the latest developments. 
6. 
STATISTICAL DESIGN AND ANALYSIS 
6.1 Statistical Overview of the Trial 
The primary sample size calculation is based on the hypotheses that the primary safety and 
effectiveness endpoints meet a priori specified Objective Performance Criteria (OPC). 
The OPCs for the primary safety endpoint and effectiveness endpoints have been set 
using historical control data from thirty-two (32) published studies that evaluate 
treatments for ISR, analyzed in meta-analysis and also reviewed in a consensus 
document6. Since this is a feasibility trial, the attainment of statistical significance is 
neither a necessary nor a sufficient condition for determine whether the device merits 
further study. If the data exhibit a trend (p≤ 0.10) toward statistical significance when 
compared to historical control and raise no safety concerns, it may be deemed worthy of 
further investigation. In addition, there will be a focus on estimating the magnitude of 
observed values at 180 days post-procedure and their associated 90% confidence 
 
6  Jeger et al. Third International DCB Consensus Group Report JACC: Cardiovascular Interventions, 2020June;1 3(12):1391-402 
  Ae-Young Her et al. Current Management of In-Stent Restenosis, Korean Circ J. 2018 May;48(5):337-349 
  Leos Pleva et al. Treatment of coronary in-stent restenosis: a systematic review J Geriatr Cardiol 2018; 15: 173-184 
 

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intervals. 
6.2 Analysis Populations 
The primary endpoints will be analyzed on the entire safety population and on the 
evaluable subject population, as appropriate.  
The safety population will consist of all subjects who enrolled into the trial and for whom 
the procedure had been initiated. 
All effectiveness endpoints will be analyzed using the evaluable population, which 
consists of subjects who had no bailout and at least one valid follow-up visit.  
6.3 Sample Size Justification 
Approximately 50 subjects at up to 15 active sites will be enrolled in the CVT-ISR Trial. 
All subjects will be scheduled for clinical examination at six (6) months. The objective of 
the study is to assess the initial feasibility and performance of the CVT Everolimus-
Coated PTCA Catheter in the treatment of subjects presenting in-stent restenosis in 
coronary arteries. The study is powered (per PASS13) based on the primary safety and 
effectiveness endpoints.  
The primary safety endpoint for this analysis is freedom from target lesion failure (TLF) 
rate at 6 months post-index procedure, defined as a composite rate of all cardiac death, 
target vessel myocardial infarction and clinically-driven target lesion revascularization 
(TLR). The null (H0) and alternative (HA) hypotheses are: 
H0:  ffTLF historical control d ffTLF CVT treatment 
HA:  ffTLFhistorical control > ffTLF CVT treatment 
The proposed sample size of N=50 is based on the primary safety endpoint of freedom 
from TLF rate at 6 months post-index procedure. The sample size calculation is based on 
the following assumptions: 
x A single comparison of CVT Treatment group to a safety OPC of 65%. 
o A positive safety endpoint result would be where the lower limit of the 90% CI 
exceeded the OPC=65%  
o One-tailed α=0.05 
The safety focus will be to estimate the frequency of TLF at six (6) months post-
procedure and the associated 90% confidence interval. 
If 8 of 50 (16%) subjects experience TLF, the point estimate for ffTLF is 84% and 
corresponding the 90% CI is [73%, 92%], well above the OPC of 65%.  
By enrolling 50 subjects there is 95% power to detect a 19%-point margin over the Safety 
OPC, with a one-tailed α=0.05. 
The primary effectiveness endpoint is late lumen loss at six (6) months.  The null (H0) and 
alternative (HA) hypotheses are: 
H0:  Late Loss historical control d Mean Late Loss CVT treatment 
HA:  Late Loss historical control > Mean Late Loss CVT treatment 

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The power calculation is based on the following assumptions: 
x A single comparison of CVT Treatment group to an historical control group. 
x A true mean difference between the historical control group and the treatment group of 
0.50 mm. This assumption is made based on the results of historical studies. Assuming 
the true mean late loss for the CVT treatment group is 0.30 mm, the difference between 
the control group and treatment group is calculated as: 0.80 mm – 0.30 mm = 0.50 mm. 
o Standard deviation is assumed to be 0.5 mm in the treatment group. 
x Two-tailed α=0.10 
Given the above assumptions, enrolling 25 subjects (analysis of 25 evaluable subjects) 
will provide 87% power for demonstrating CVT treatment’s superiority over historical 
controls in LLL. 
6.4 Statistical Analyses 
Detailed analyses of the primary endpoints will be performed when all of the subjects 
complete their primary follow-up visit at 180 days. No effort will be made to impute or 
extrapolate data to replace missing values. All calculations will be based on available 
data with missing data excluded.  
Analysis of Primary Endpoints 
The primary safety endpoint of freedom from target lesion failure (TLF) rate at 6 months 
post-index procedure will be analyzed using the safety population.  
The analysis of the primary effectiveness endpoint of LLL at 6 months will utilize the 
evaluable populations.  
Analysis of Secondary Endpoints 
All secondary endpoints will be analyzed using descriptive statistics. 
For binary variables, such as technical success counts, percentages and exact 95% 
confidence intervals using Clopper-Pearson’s method will be calculated. For continuous 
variables, means, standard deviations, and 95% confidence intervals for the mean using 
the Gaussian approximation will be calculated. If the assumption of normality seems 
untenable, nonparametric methods will be employed instead. 
For time-to-event variables, such as time to target lesion revascularization, survival 
curves will be constructed using Kaplan-Meier estimates. 
Analysis of Other Data 
The clinical laboratory values collected will be analyzed by tabulating the number and 
percentage of subjects with clinically significant changes from baseline for each 
parameter at each time point. 
7. 
RISK ASSESSMENT 
7.1 Potential Risks from Percutaneous Coronary Diagnostic and Treatment Procedures 
It is expected that risks associated with using CVT Everolimus-coated PTCA Catheter 
are those associated with treatment procedures and percutaneous coronary diagnostic 

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including angiography, intravascular ultrasound (IVUS) and optical coherence 
tomography (OCT). These risks may include but are not limited to the following: acute 
myocardial infarction, aneurysm, arrhythmias, including ventricular fibrillation, arterial 
dissection, arteriovenous fistula, bleeding, coronary artery spasm, coronary artery 
thrombosis, death, discomfort during procedure, drug reactions or allergic reactions to 
contrast medium, distal embolism (air, thrombus, plaque) or device embolism, 
endocarditis, fever, groin bruising/discomfort, hematoma, hemorrhage, 
hypotension/hypertension, injury at blood vessel access site, ischemia, pseudoaneurysm, 
renal failure, restenosis of the dilated vessel, sepsis/infection, stroke or cerebrovascular 
event, total occlusion of the coronary artery or bypass graft, unstable angina, vessel 
dissection, perforation, rupture or injury, thrombosis and vomiting/nausea. 
The fluoroscopy time of the angiographic follow up assessment is expected to be very 
limited and expected to be no longer than any routine diagnostic angiography. The 
Sponsor considers that this assessment does not pose additional risks to the subject or 
laboratory personnel. 
7.2 Potential Risks from Everolimus Coating 
The oral formulation of everolimus has been evaluated in clinical investigations and has been 
approved in more than 90 countries. Everolimus has been approved for more than a decade 
and used as an immunosuppressant to prevent rejection of organ transplants and in the 
treatment of a number of cancers. Everolimus marketed under the trade 
names Zortress (USA), Certican (European Union and other countries) in transplantation 
medicine, and as Afinitor and Votubia in oncology7. 
In animal studies, everolimus has shown a low acute toxic potential. No lethality or 
severe toxicity were observed in either mice or rats given single oral doses of 2000 mg/kg 
(limit test). In humans the toxicity data is limited; single doses of up to 70 mg have been 
administered with no difference in acute toxicity profile of what was observed for the 10 
mg dose. 
Everolimus is often used in combination with cyclosporine (microemulsion formulation) 
and corticosteroids.  
Subjects treated with everolimus usually receive doses ranging up to 10mg/day over 
several months period and extending up to a year or more with achievement of state 
concentration within 4 to 7 days.  
The following adverse events were noted in everolimus clinical investigations: 
Abdominal pain, anemia, angioedema, anorexia, asthenia, constipation, cough, delayed 
wound healing/fluid accumulation, diarrhea, dyslipidemia, dyspnea, dysgeusia, 
dyspepsia, dysuria, dry skin, edema (peripheral), epistaxis, fatigue, headache, hematuria, 
hyperglycemia, hyperkalemia, hypertension, hypokalemia, hypomagnesaemia, 
hypophosphatemia, increased serum creatinine, infections, insomnia, interaction with 
strong inhibitors/inducers of CYP3A4 or PgP, leukopenia, male infertility, mucosal 
inflammation, nausea, neutropenia, non-infectious pneumonitis, pain, proteinuria, 
 
7  Trimukhe R, Vani P, Patel A, Salgotra V. Safety and performance of the EverProTM everolimus-eluting coronary stent system with 
biodegradable polymer in a real-world scenario. World J Cardiol. 2020;12(12):615-625. doi:10.4330/wjc.v12.i12.615 
Meng, M., Gao, B., Wang, X. et al. Long-term clinical outcomes of everolimus-eluting stent versus paclitaxel-eluting stent in patients 
undergoing percutaneous coronary interventions: a meta-analysis. BMC Cardiovasc Disord 16, 34 (2016). 
 

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pruritus, pyrexia, rash, stomatitis, thrombocytopenia, thrombotic microangiography, 
thrombotic thrombocytopenic purpura, tremor, urinary tract infection, upper respiratory 
tract infection and vomiting8.  
Certain side effects and discomforts have been reported in subjects that have received 
everolimus in intravenous (IV) form as part of chemotherapy treatment. These subjects 
may have other comorbid conditions and/or have received concomitant medications that 
may also have contributed to the reported side effects. In the IV setting, the dose is 
delivered throughout the body and in doses hundreds of times higher than the total 
amount present on the CVT Everolimus-coated PTCA Catheter used in this clinical 
study. The side effects reported by the chemotherapy subjects include 
allergic/immunologic reactions, alopecia, anemia, blood product transfusion, gastro-
intestinal symptoms, hematologic dyscrasia (including leukopenia, neutropenia, 
thrombocytopenia), hepatic enzyme changes, histologic changes in vessel wall, cellular 
damage or necrosis, myalgia/arthralgia and peripheral neuropathy. 
Based on all current information available to date on everolimus as a drug entity and on 
the CVT Everolimus-coated PTCA Catheter as a device, it is unlikely, with the total 
dosage on the CVT Everolimus-coated PTCA Catheter and the targeted vessel delivery of 
the everolimus, that the side effects associated with high dose of everolimus would occur. 
7.3 Risk Management Procedure 
The CVT-ISR Trial will be conducted by skilled and trained investigators relative to 
interventional procedures. The research team at each clinical site will undergo specific in-
servicing and training prior to initiation of the study. 
Subjects will be monitored closely throughout the study duration. Subjects will be 
evaluated clinically at pre-determined time points to assess their clinical condition. The 
subject’s medication regimen will be in line with standard of care requirements for 
coronary interventional procedures. 
7.4 Potential Benefits 
The potential benefits of the CVT Everolimus-coated PTCA Catheter have not been 
documented; nevertheless, subjects who undergo Percutaneous Transluminal Coronary 
Angioplasty (PTCA) of the coronary arteries may benefit by the use of the everolimus-
coated coronary balloon because everolimus is a drug with a proven safety profile with 
long-term, worldwide use in drug-eluting stents (DES) considered as the percutaneous 
treatment of choice for coronary artery disease (CAD). Also, the use of CVT Everolimus-
coated PTCA Catheter may eliminate, decrease and/or delay the chance of restenosis and 
re-occlusion in the treated artery, with an expected subsequent clinical benefit in terms of 
symptom relief. 
8. 
DATA HANDLING, RECORD KEEPING AND REPORTING 
8.1 Case Report Form (CRF) Completion 
All required study data will be accurately recorded by authorized personnel on CRFs 
which will be provided by CVT. 
 
8   Certican® (Everolimus) Product Insert. Novartis, Mar 2013.  

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8.2 Source Documentation 
Regulations require that investigators maintain information in the subject’s medical 
records, which corroborate data collected on the CRFs. Investigators will maintain all 
records pertaining to this study as mandated by the hospital requirements and national 
laws and regulations. 
8.3 Reports 
A report will be created after the primary endpoints have been analyzed and a final report 
on the study will be completed at the end of the study. Interim reports may be compiled, 
at the request of the sponsor, for regulatory purposes. 
9. 
REGULATORY REQUIREMENTS 
9.1 Investigator’s Responsibility 
Prior to registering subjects for this study, the investigator must read and understand the 
protocol and must sign and complete an investigator agreement form. The investigator 
agreement form documents the investigator’s agreement to all conditions of the protocol 
and an agreement to conduct the study accordingly. 
This study will be conducted in accordance with Good Clinical Practice (GCP), 
ISO14155:2020 and the Declaration of Helsinki as well as any local regulations. 
Additional requirements must be met by the investigator and participating institutions. 
9.2 Compliance with Protocol and Protocol Amendments 
A protocol deviation is defined as any change, divergence, or departure from the study 
design or procedures of a research protocol that is under the invetigator’s control and that 
has not been approved by the IRB/EC. The investigator is responsible for promptly 
reporting protocol deviations to their IRB/EC per IRB/EC policy and to the sponsor. The 
sponsor will determine the effect of the protocol deviation on the scientific soundness of 
the clinical study and subject safety and determine if additional reports or actions are 
required. Additional action may include site re-training, removal of the devices, and/or 
site termination. 
The investigator will not implement any changes to the protocol without first obtaining in 
written agreement from the sponsor and documented approval from the EC, except in the 
event of an immediate hazard to the subject. The investigator will report the deviation in 
accordance with the applicable regulations. 
9.3 Investigator Requirements 
All investigators must submit the following documentation to be considered approved 
investigators. Sponsor will make final determination of approved investigators. 
x Signed investigator’s agreement 
x Completed device training 
Investigators must allow CVT or representatives of CVT to visit the site to periodically 
assess the data quality and study integrity. On site, CVT, or its representatives, will 
review study records in comparison with source documents, discuss the conduct of the 

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study and verify that the facilities remain acceptable. In addition, the study may be 
evaluated by government inspectors who must be allowed access to CRFs, source 
documents and other study files. 
The investigator must notify CVT promptly of any inspections scheduled by regulatory 
authorities, and promptly forward copies of inspection reports to CVT. 
The investigator should retain essential documents at least two years after the last 
approval of a marketing application and until there are no pending or contemplated 
marketing applications, or at least two years have elapsed since the formal 
discontinuation of clinical development of the investigational product. These documents 
should be retained for a longer period, however if required by the applicable regulatory 
requirements or by an agreement with the sponsor. It is the responsibility of the sponsor 
to inform the investigator/institution as to when these documents no longer need to be 
retained. 
9.4 Institutional Requirements 
The investigator and institution are required to submit the following documentation prior 
to shipment of first device and first implant. 
x IRB/EC approved informed consent form 
x IRB/EC approval of the final protocol 
Any additional requirements imposed by the IRB/EC or regulatory authorities concerning 
the trial shall be followed. 
9.5 Informed Subject Consent 
If it is mandated by the respective country regulations, study subjects must provide 
written informed consent using an IRB/EC-approved informed consent form. The study 
must be explained to the study subjects in lay language. The investigator, or 
representative, must be available to answer all of study subject’s questions. Subjects will 
be assured that they may withdraw at any time for any reason and receive alternative 
conventional therapy as indicated. 
9.6 Device Accountability 
This trial is a first-in-human study and devices may not be used for the treatment of 
subjects not qualified for inclusion into the study. The Investigator will maintain 
adequate records of the receipt and disposition of the investigational device, including lot 
numbers, device identification number, date used, subject ID number and treating 
physician. A device accountability log supplied by the Sponsor will be used. 
Use of any investigational device outside of the protocol is strictly forbidden and may 
constitute grounds for removal of the investigator/site from the clinical trial/investigation. 
9.7 Use of Information and Publication 
All information and data generated in association with this study will be held in strict 
confidence until the study completion. The investigator agrees to use this information for 
the sole purpose of completing this study and for no other purpose without written 
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At the conclusion of each follow-up time point and the entire study, an abstract reporting 
the primary results may prepared and presented in an appropriate international forum. A 
manuscript may also be prepared for publication in a scientific journal. The data and 
results from the study are the sole property of CVT. CVT shall have the right to access 
and use all data and results generated during the study. CVT acknowledges that the 
Principal Investigator(s) might desire to publish a multi-center publication regarding the 
trial results. CVT must receive any proposed publication and/or presentation materials at 
least 60 days prior to the proposed date of the presentation or the initial submission of the 
proposed publication in order for the materials to be reviewed by CVT in compliance 
with CVT publication policy set forth in the Research Agreement or Investigator’s 
Agreement. 
9.8 Reporting Requirements 
The investigator should notify the IRB/EC in writing within three months after 
completion, termination or discontinuation of the study at the site. The same procedure 
will be applied to Competent Authority where required. A site reporting requirements 
summary is presented in Table 3. 
Table 4. CVT-ISR Study Site Responsibilities for Submitting Data and Reports 
Type of CRF/Report 
Time Frame 
Process 
CRF (baseline, in-hospital 
summary, follow-up, 
non-compliance, reconciliation 
form, subject withdrawal) 
Ongoing basis 
CRF 
Adverse Events 
Ongoing Basis 
CRF 
Details to be retrieved at 
monitoring visit 
Serious Adverse Event 
Notification CRF (including 
death, device malfunction; failure, 
near incident, unanticipated 
adverse device effects) 
Within 24 hours 
Input within 24 hours of 
knowledge of event 
Annual reports 
Annually, as required 
by Ethic Committee 
Material to be prepared by 
sponsor and copy to be 
provided to EC by 
investigator 
Final report 
Within 6 months of 
study completion or 
termination 
Material to be prepared by 
sponsor and copy to be 
provided to EC by 
investigator 
 
 
 

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10. SPONSOR RESPONSIBILITIES COMPLIANCE/QUALITY ASSURANCE 
10.1 Role of Sponsor 
As the study Sponsor, CVT has the overall responsibility for the conduct of the study, 
including assurance that the study satisfies international standards and the regulatory 
requirements of the relevant Competent Authorities. 
10.2 General Duties 
It is the Sponsor’s responsibility to ensure that the study is conducted according to Good 
Clinical Practice (GCP), ISO 14155:2020, the Declaration of Helsinki, and other 
applicable regulatory requirements, the study protocol, or any conditions of approval 
imposed by the IRB/EC or regulatory authorities. Additionally, the sponsor will ensure 
proper clinical site monitoring is conducted.  
10.3 Selection of Clinical Investigators and Sites 
The Sponsor will select qualified investigators and facilities which have adequate study 
subject population to meet the requirements of the investigation. 
10.4 Training of Investigator and Site Personnel and Monitoring 
The training of the investigator, and appropriate clinical site personnel will be the 
responsibility of the Sponsor and PI, or designee, and may be conducted during an 
investigator meeting, a site initiation visit or other appropriate training sessions. 
Periodic monitoring visits will be conducted frequently enough to ensure that all clinical 
subject data are properly documented and that the study is properly conducted. 
10.5 Investigator's Brochure 
The Sponsor will prepare, assemble and maintain all pre-clinical and available clinical 
data and documentation and summarize this information in the clinical investigator's 
brochure. 
10.6 Documentation 
The Sponsor will collect, store, guard and ensure completion by the relevant parties of the 
following documents: 
x Records of any serious adverse events (SAEs) reported to the sponsor during the 
clinical investigation 
x Any statistical analyses and underlying supporting data 
x The final report of the clinical investigation 
10.7 Committees 
Clinical Events Committee 
The clinical events committee (CEC) is made up of angiologists/radiologists/cardiologists 
or vascular surgeons who are not participants in the study. The clinical events committee 
is charged with the development of specific criteria used for the categorization of clinical 
events and clinical endpoints in the study which are based on the protocol. 
At the onset of the trial, the clinical events committee will establish explicit rules 
outlining the minimum amount of data required and the algorithm to be followed in order 

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to classify a clinical event. All members of the clinical events committee will be blinded 
to the primary results of the trial. 
The clinical events committee will meet regularly to review and adjudicate all clinical 
events in which the required minimum data is not available. The committee will also 
review and rule on all deaths that occur throughout the trial. 
Steering Committee 
The steering committee (SC) is the main policy and decision-making committee of the 
study and has final responsibility for the scientific conduct. The specific tasks of the SC 
are to: 
x Proper design and conduct of the trial 
x Ethical and professional standards of the trial 
x Ensuring that the results of the clinical trial and the scientific accomplishments are 
arrived at in the most efficient manner possible 
x Periodical safety review 
x Publication policy 
The steering committee will be composed of the lead principal investigator, at least one 
investigator of a clinic participating in the trial and representatives from CVT. 
11. TRIAL TERMINATION 
The Sponsor and steering committee will monitor the progression of the study. If warranted, 
the study may be suspended or discontinued early if there is an observation of serious adverse 
reactions presenting an unreasonable risk to the study population. 
Notification of suspension or termination will occur no later than five (5) working days after 
Sponsor makes the determination. In the event of study suspension or termination, the Sponsor 
will send a report outlining the circumstances to the IRB/EC and all investigators. A 
suspended or terminated study may not be reinitiated without approval of the reviewing 
IRB/EC (where applicable). 
12. APPENDICES 
x Appendix A: 
Bibliographical References 
x Appendix B: 
Trial Abbreviations and Definitions 
x Appendix C: 
Informed Consent (LBL1120) 
x Appendix D: 
Helsinki Declaration 
x Appendix E: 
Instructions for Use (LBL1121) 
x Appendix F: 
Schedule of Events 
x Appendix G: 
Research Agreement Template (FRM1122) 
x Appendix H: 
Investigators Responsibilities 
x Appendix I: 
Angiographic Core Lab Guidelines and Worksheet 
x Appendix J: 
Risk Analysis 

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x Appendix K: 
General Safety and Performance Requirements Statement 
x Appendix L: 
Case Report Forms (FRM1123) 
 
 

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APPENDIX A: BIBLIOGRAPHICAL REFERENCES 
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Koning R, Eltchaninoff H, Commeau P, et al. Stent placement compared with balloon angioplasty for 
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Agostoni P, Biondi-Zoccai GG, Gasparini GL, et al. Is bare-metal stenting superior to balloon 
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11. Moses JW, Leon MB, Popma JJ, et al. Sirolimus-eluting stents versus standard stents in patients with 
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in 
a 
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atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-
SIRIUS). Lancet. 2003;362(9390):1093-1099. doi:10.1016/S0140-6736(03)14462-5 
 
 

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13. Schampaert E, Cohen EA, Schlüter M, et al. The Canadian study of the sirolimus-eluting stent in the 
treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS). J Am 
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14. Grube E, Silber S, Hauptmann KE, et al. TAXUS I: six- and twelve-month results from a randomized, 
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2003;107(1):38-42. doi:10.1161/01.cir.0000047700.58683.a1 
15. Colombo A, Drzewiecki J, Banning A, et al. Randomized study to assess the effectiveness of slow- 
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2003;108(7):788-794. doi:10.1161/01.CIR.0000086926.62288.A6 
16. Stone GW, Ellis SG, Cox DA, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary 
artery disease. N Engl J Med. 2004;350(3):221-231. doi:10.1056/NEJMoa032441 
17. Stone GW, Ellis SG, Cannon L, et al. Comparison of a polymer-based paclitaxel-eluting stent with a 
bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA. 
2005;294(10):1215-1223. doi:10.1001/jama.294.10.1215 
18. Dawkins KD, Grube E, Guagliumi G, et al. Clinical efficacy of polymer-based paclitaxel-eluting stents 
in the treatment of complex, long coronary artery lesions from a multicenter, randomized trial: support 
for the use of drug-eluting stents in contemporary clinical practice. Circulation. 2005;112(21):3306-
3313. doi:10.1161/CIRCULATIONAHA.105.552190 
19. Torrado J, Buckley L, Durán A, et al. Restenosis, Stent Thrombosis, and Bleeding Complications: 
Navigating Between Scylla and Charybdis. J Am Coll Cardiol. 2018;71(15):1676-1695. 
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20. Cutlip DE, Baim DS, Ho KK, et al. Stent thrombosis in the modern era: a pooled analysis of multicenter 
coronary stent clinical trials. Circulation. 2001;103(15):1967-1971. doi:10.1161/01.cir.103.15.1967 
21. Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R. In-stent restenosis in the 
drug-eluting stent era. J Am Coll Cardiol. 2010;56(23):1897-1907. doi:10.1016/j.jacc.2010.07.028 
22. Magalhaes MA, Minha S, Chen F, et al. Clinical presentation and outcomes of coronary in-stent 
restenosis 
across 
3-stent 
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Circ 
Cardiovasc 
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2014;7(6):768-776. 
doi:10.1161/CIRCINTERVENTIONS.114.001341 
23. García Del Blanco B, Rumoroso Cuevas JR, Hernández Hernández F, Trillo Nouche R. Spanish cardiac 
catheterization and coronary intervention registry. 22nd official report of the Spanish Society of 
Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology (1990-2012). 
Rev Esp Cardiol (Engl Ed). 2013;66(11):894-904. doi:10.1016/j.rec.2013.08.001 
24. Pleva L, Kukla P, Hlinomaz O. Treatment of coronary in-stent restenosis: a systematic review. J Geriatr 
Cardiol. 2018;15(2):173-184. doi:10.11909/j.issn.1671-5411.2018.02.007 
25. Buccheri D, Piraino D, Andolina G, Cortese B. Understanding and managing in-stent restenosis: a 
review of clinical data, from pathogenesis to treatment. J Thorac Dis. 2016 Oct;8(10):E1150-E1162 
26. Alraies MC, Darmoch F, Tummala R, Waksman R. Diagnosis and management challenges of in-stent 
restenosis in coronary arteries. World J Cardiol. 2017;9(8):640-651. doi:10.4330/wjc.v9.i8.640 

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27. Shlofmitz E, Iantorno M, Waksman R. Restenosis of Drug-Eluting Stents: A New Classification 
System Based on Disease Mechanism to Guide Treatment and State-of-the-Art Review [published 
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2019;12(8):e007023. doi:10.1161/CIRCINTERVENTIONS.118.007023 
28. Moustapha A, Assali AR, Sdringola S, et al. Abciximab administration and clinical outcomes after 
percutaneous intervention for in-stent restenosis. Catheter Cardiovasc Interv. 2002;56(2):184-187. 
doi:10.1002/ccd.10166 
29. Hausleiter J, Kastrati A, Mehilli J, et al. Randomized, double-blind, placebo-controlled trial of oral 
sirolimus for restenosis prevention in patients with in-stent restenosis: the Oral Sirolimus to Inhibit 
Recurrent 
In-stent 
Stenosis 
(OSIRIS) 
trial. 
Circulation. 
2004;110(7):790-795. 
doi:10.1161/01.CIR.0000138935.17503.35 
30. Kufner S, Hausleiter J, Ndrepepa G, et al. Long-term risk of adverse outcomes and new malignancies 
in patients treated with oral sirolimus for prevention of restenosis. JACC Cardiovasc Interv. 
2009;2(11):1142-1148. doi:10.1016/j.jcin.2009.08.015 
31. Alfonso F, Pérez-Vizcayno MJ, Cruz A, et al. Treatment of patients with in-stent restenosis. 
EuroIntervention. 2009;5 Suppl D:D70-D78. 
32. Authors/Task Force members, Windecker S, Kolh P, et al. 2014 ESC/EACTS Guidelines on 
myocardial revascularization: The Task Force on Myocardial Revascularization of the European 
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(EACTS)Developed with the special contribution of the European Association of Percutaneous 
Cardiovascular 
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33. Albiero R, Silber S, Di Mario C, et al. Cutting balloon versus conventional balloon angioplasty for the 
treatment of in-stent restenosis: results of the restenosis cutting balloon evaluation trial (RESCUT). J 
Am Coll Cardiol. 2004;43(6):943-949. doi:10.1016/j.jacc.2003.09.054 
34. Lemos PA, Hoye A, Goedhart D, et al. Clinical, angiographic, and procedural predictors of 
angiographic restenosis after sirolimus-eluting stent implantation in complex patients: an evaluation 
from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) study. 
Circulation 2004; 109:1366. 
35. Alfonso F, Zueco J, Cequier A, et al. A randomized comparison of repeat stenting with balloon 
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46:756. 
37. Mehran R, Dangas G, Abizaid A, et al. Treatment of focal in-stent restenosis with balloon angioplasty 
alone versus stenting: Short- and long-term results. Am Heart J 2001; 141:610. 
38. Sousa JE, Costa MA, Abizaid A, et al. Sirolimus-eluting stent for the treatment of in-stent restenosis: 
a quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation 
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39. Degertekin M, Regar E, Tanabe K, et al. Sirolimus-eluting stent for treatment of complex in-stent 
restenosis: the first clinical experience. J Am Coll Cardiol 2003; 41:184. 
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treatment of restenosis after coronary stent placement. Circulation 2005; 111:2107. 
41. Kastrati A, Mehilli J, von Beckerath N, et al. Sirolimus-eluting stent or paclitaxel-eluting stent vs 
balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a 
randomized controlled trial. JAMA 2005; 293:165. 
42. Alfonso F, Pérez-Vizcayno MJ, Hernandez R, et al. A randomized comparison of sirolimus-eluting 
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2006; 47:2152. 
43. Alfonso F, Pérez-Vizcayno MJ, Hernández R, et al. Long-term clinical benefit of sirolimus-eluting 
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angioplasty vs. elective sirolimus-eluting Stenting) study. J Am Coll Cardiol 2008; 52:1621. 
44. Garg S, Smith K, Torguson R, et al. Treatment of drug-eluting stent restenosis with the same versus 
different drug-eluting stent. Catheter Cardiovasc Interv 2007; 70:9. 
45. Abe M, Kimura T, Morimoto T, et al. Sirolimus-eluting stent versus balloon angioplasty for sirolimus-
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46. Stone GW, Ellis SG, O'Shaughnessy CD, et al. Paclitaxel-eluting stents vs vascular brachytherapy for 
in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. JAMA 2006; 
295:1253. 
47. Holmes DR Jr, Teirstein P, Satler L, et al. Sirolimus-eluting stents vs vascular brachytherapy for in-
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48. Ellis SG, O'Shaughnessy CD, Martin SL, et al. Two-year clinical outcomes after paclitaxel-eluting 
stent or brachytherapy treatment for bare metal stent restenosis: the TAXUS V ISR trial. Eur Heart J 
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49. Siontis GC, Stefanini GG, Mavridis D, et al. Percutaneous coronary interventional strategies for 
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50. Giacoppo D, Colleran R, Cassese S, et al. Percutaneous Coronary Intervention vs Coronary Artery 
Bypass Grafting in Patients With Left Main Coronary Artery Stenosis: A Systematic Review and Meta-
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51. Alraies MC, Darmoch F, Tummala R, Waksman R. Diagnosis and management challenges of in-stent 
restenosis in coronary arteries. World J Cardiol. 2017;9(8):640-651. doi:10.4330/wjc.v9.i8.640 
52. The Food and Drug Administration Update: Treatment of peripheral arterial disease with paclitaxel-
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7, 2019. https://www.fda.gov/medical-devices/letters-health-care-providers/august-7-2019-update-
treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel. Accessed December 
15, 2020. 
 
 

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53. Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of death following 
application of paclitaxel‐coated balloons and stents in the femoropopliteal artery of the leg: a 
systematic review and meta‐analysis of randomized controlled trials. J Am Heart Assoc 
2018;7:e011245. 
54. Agence Nationale de Sécurité du Medicament et des Produits de Santé, Paclitaxel-coated balloons 
and paclitaxel-eluting stents. June 18, 2020. Safety information. https://ansm.sante.fr/S-
informer/Informations-de-securite-Autres-mesures-de-securite/Ballons-recouverts-de-paclitaxel-et-stents-a-
elution-de-paclitaxel-Information-de-securite. Accessed December 15, 2020 
55. Bundesinstitut für Arzneimittel und Medizinprodukte, Field Safety Notice June 2020. 
https://www.bfarm.de/SharedDocs/Kundeninfos/EN/07/2020/08550-
20_kundeninfo_en.pdf?__blob=publicationFile&v=1. Accessed December 15, 2020 
56. Medicines & Healthcare products-Regulatory Agency, Paclitaxel drug-coated balloons (DCBs) or 
drug-eluting stents (DESs): Reconfirmed position on use in patients with intermittent claudication 
and critical limb ischaemia. 18 February 2021. https://www.gov.uk/drug-device-alerts/paclitaxel-
drug-coated-balloons-dcbs-or-drug-eluting-stents-dess-reconfirmed-position-on-use-in-patients-with-
intermittent-claudication-and-critical-limb-ischaemia. Accessed March 01, 2021 
 
 
 
 
 

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APPENDIX B:  TRIAL ABBREVIATIONS AND DEFINITIONS 
 
 
ABR  
Angiographic Binary Restenosis  
AE  
Adverse Event  
aPTT  
Activated Partial Thromboplastin Time 
AMI 
Acute Myocardial Infarction 
AV  
Arteriovenous  
BMI  
Body Mass Index  
BMS 
Bare-Metal Stent 
CABG 
Coronary Artery Bypass Graft 
CAD 
Coronary Artery Disease 
CBC  
Complete Blood Count  
CEC  
Clinical Events Committee  
CI  
Clinically Indicated  
CK 
Creatine Kinase 
CK-MB 
Creatine Kinase - Myocardial-Band isoenzyme 
COPD  
Chronic Obstructive Pulmonary Disease  
CRF  
Case Report Form  
cTn 
Cardiac Troponin 
CVA  
Cerebrovascular Accident  
CVD  
Cardiovascular Disease  
CVT 
Chansu Vascular Technologies 
DCB 
Drug Coated Balloon 
DES 
Drug-Eluting Stent 
GCP  
Good Clinical Practice  
ICH  
International Conference on Harmonisation  
ID  
Identification  
IFU  
Instructions for Use  
ISO  
International Organization for Standardization  
ISR 
In-Stent Restenosis 
ITT  
Intent-to-Treat  
IVUS 
IntraVascular UltraSound 
LLL  
Late Lumen Loss  
MACE  
Major Adverse Cardiac Event  
MEC  
Medical Ethics Committee  
MI  
Myocardial Infarction  
MLD  
Minimum Lumen Diameter  
μg  
Microgram 
OCT 
Optical Coherence Tomography 
PCI 
Percutaneous Coronary Intervention 
PT  
Prothrombin Time  
PTCA  
Percutaneous Transluminal Coronary Angioplasty  
QA  
Quantitative Angiography  
RVD  
Reference Vessel Diameter  
SAE  
Serious Adverse Event  
SC  
Steering Committee  
TLF 
Target lesion failure 

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TLR  
Target Lesion Revascularization  
TnT 
Troponin T 
TVF 
Target Vessel Failure 
TVR 
Target Vessel Revascularization 
 
 
 

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Acute Closure 
 
The occurrence of new (during the procedure) severely reduced flow (TIMI grade 0-1) within the 
target vessel that persisted and required rescue by stenting or other treatment, or resulted in 
myocardial infarction or death. Abrupt closure requires proven association with a mechanical 
dissection of the treatment site or instrumented vessel, coronary thrombus, or severe spasm. Abrupt 
closure does not mean “no reflow” (due to microvascular flow limitation), in which the epicardial 
artery is patent but had reduced flow. Abrupt closure also does not mean transient closure with 
reduced flow in which the index treatment application does reverse the closure. 
Adverse Event (AE) 
 
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or 
not related to the investigational medical device. 
Aneurysm 
A localized abnormal expansion or protrusion of a blood vessel resulting from a disease or weakening 
of the vessel’s wall (all 3 layers) that exceeds the reference vessel diameter (RVD) of the vessel by 
1.5 times 
Angina Pectoris 
 
Braunwald Classification of Unstable Angina: 
 
 New onset of severe or accelerated angina. Patients with new onset (< 2 months in duration) 
exertional angina pectoris that is severe or frequent (> 3 episodes/day) or patients with chronic stable 
angina who develop accelerated angina (that is, angina distinctly more frequent, severe, longer in 
duration, or precipitated by distinctly less exertion than previously) but who have not experienced 
pain at rest during the preceding 2 months. 
 
 Angina at rest, subacute. Patients with one or more episodes of angina at rest during the preceding 
month but not within the preceding 48 hours. 
 
 Angina at rest, acute. Patients with one or more episodes of angina at rest within the preceding 48 
hours. 
 
Canadian Cardiovascular Society (CCS) Classification of Stable Angina: 
 
 Ordinary physical activity does not cause angina; for example walking or climbing stairs, angina 
occurs with strenuous or rapid or prolonged exertion at work or recreation. 
 
 Slight limitation of ordinary activity; for example, angina occurs walking or stair climbing after 
meals, in cold, in wind, under emotional stress or only during the few hours after awakening, 
walking more than two blocks on the level or climbing more than one flight of ordinary stairs at a 
normal pace and in normal conditions. 
 
 Marked limitation of ordinary activity; for example, angina occurs walking one or two blocks on the 
level or climbing one flight of stairs in normal conditions and at a normal pace. 
Inability to carry on any physical activity without discomfort - angina syndrome may be present at 
rest. 
Angiographic Binary Restenosis (ABR) Rate 
 
Percent of patients with an in-lesion percent diameter stenosis of > 50%, by quantitative angiography 
(QA), at follow-up. 
Binary Restenosis 

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Defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by 
quantitative angiography (QA). 
Cerebrovascular Accident (CVA) or Stroke 
 
Stroke or Cerebrovascular Accident is defined as sudden onset of focal neurological deficits due to 
vascular lesions of the brain that persists >24 hours. This may include cerebral infarction (ischemic 
stroke), intracerebral hemorrhage, and subarachnoid hemorrhage (hemorrhagic stroke). 
Chronic Concomitant Medications 
 
Medication that has been: 
• 
Prescribed or over-the-counter (OTC) that has been taken or will continue to be taken regularly 
for at least a period of 6 months, or 
• 
Is required to be taken indefinitely by the patient, or 
• 
Prescribed or OTC that has been taken multiple times (each time for at least 6 months). 
Clinically Relevant Myocardial Infarction after Coronary Revascularization: 
1) In subjects with normal baseline values:  
Elevation of CK-MB values ≥10xURL (Upper Reference Limit) or TnT values ≥70xURL within 48 
hours of the procedure  
Or  
Elevation of CK-MB values ≥5xURL or TnT values ≥35xURL with new pathological Q-waves in 2 
contiguous leads or new persistent left bundle branch block (LBBB) in ECG,  
2) In subjects without CK-MB measurements and a normal baseline cardiac troponin (cTn I or T) level 
measured within 48 hours of the PCI rises to ≥70xURL, or ≥35xURL with new pathological Q-waves 
in 2 contiguous leads, or new persistent LBBB. 
3) In subjects with elevated baseline values, but stable or falling, Increment rise of CK-MB ≥10xURL or 
TnT values ≥70xURL. 
4) In subjects with elevated baseline values, but  not stable or falling, Increment rise of CKMB≥10xURL 
or TnT values ≥70xURL with new pathological Q-waves in 2 contiguous leads or new persistent 
LBBB in ECG. 
Death 
 
When possible, death will be classified according to underlying cause. Death within 30 days of the 
study procedure will be classified as procedure related unless demonstrated otherwise. 
Cardiovascular death.It is defined as death resulting from cardiovascular causes. The following 
categories may be collected: 1. Death caused by acute MI 2. Death caused by sudden cardiac, 
including unwitnessed, death, 3. Death resulting from heart failure, 4. Death caused by stroke, 5. 
Death caused by cardiovascular procedures, 6. Death resulting from cardiovascular 
hemorrhage, 7. Death resulting from other cardiovascular cause. 
 
Noncardiovasculardeath.  It is defined as any death that is not thought to be the result of a 
cardiovascular cause. The following categories may be collected: 1. Death resulting from 
malignancy, 2. Death resulting from pulmonary causes, 3. Death caused by infection (includes 
sepsis), 4. Death resulting from gastrointestinal causes, 5. Death resulting from accident/trauma, 6. 
Death caused by other noncardiovascular organ failure, 7. Death resulting from other, 
noncardiovascular cause 

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Undetermined. It is defined as a death not attributable to any other category because of the absence 
of any relevant source documents. Such deaths will be classified as cardiovascular for end point 
determination.  
Device Malfunction 
 
A malfunction is a failure of a device to meet its performance specifications or otherwise perform as 
intended. Performance specifications include all claims made in the labeling of the device. The 
intended performance of a device refers to the intended use for which the device is labeled 
Dissection Grades 
 
National Heart, Lung, and Blood Institute (NHLBI) Dissection Classification System: (0, A, B, C, D, 
E, F) 
0: 
No dissection 
A 
Minor radiolucent areas in the lumen without impairment of flow or persistent dye staining 
after contrast runoff 
B 
Luminal flap that is radiolucent and that runs parallel to the vessel wall with contrast 
injection but without impairment of flow or persistent dye staining after contrast runoff 
C: 
Contrast appears outside of the vessel lumen as an "extra-luminal cap". The staining appears 
even after contrast clears the lumen 
D: 
Spiral radiolucent luminal filling defects. Often persistent staining after contrast clears from 
the vessel. 
E: 
New and persistent filling defects in the vessel lumen. 
F: 
Lesions that progress to impaired flow or total occlusion. 
Embolism 
 
Formation of a thrombus within the target lesion with migration or atherosclerotic emboli migration 
to a distal artery. 
Hematoma 
 
A localized collection of blood in a space or tissue. 
Intent-to-Treat (ITT) Population 
 
The principle of including outcomes of all patients in the analysis who are enrolled into the clinical 
trial/investigation, regardless of the treatment actually received. 
Late Lumen Loss (LLL) 
 
Calculated as Minimum Lumen Diameter (MLD) post-procedure – MLD at follow-up 
 
Mean in-lesion Late Loss will also be measured: (Mean In-lesion MLD, post-procedure) – (Mean In-
lesion MLD at follow-up) 
Lead Principal Investigator 
 
A physician-specialist, related to the study, which is responsible for the overall conduct of the trial at 
all sites. 
Major Adverse Cardiac Event (MACE) 
 
Death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or 
clinically driven repeat target lesion revascularization by percutaneous or surgical methods.  
Minimum Lumen Diameter (MLD) 

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The average of two orthogonal views (when possible) of the narrowest point within the area of 
assessment – in lesion, in stent or in segment. MLD is visually estimated during angiography by the 
Investigator; it is measured during QA by the Angiographic Core Lab. 
Occlusion 
 
Incomplete vessel opacification distal to the lesion or if the distal vessel fills via collateral 
circulation. 
 
  
Chronic Occlusion: 
 
An occlusion presumed to have been present for at least 1 month prior to the 
procedure. 
 
  
Total Occlusion: 
 
  
 
An occlusion with no ante grade filling of contrast to the distal segment. 
Percent Diameter Stenosis 
 
The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views 
(when possible) by QA. 
Reference Vessel Diameter (RVD) 
 
An approximation of the diameter of the vessel at the location of the target lesion. RVD is visually 
estimated during angiography by the Investigator and it is measured during QA by the Angiographic 
Core Laboratory. 
Restenosis 
 
Re-narrowing of the artery following the reduction of a previous narrowing. It is defined as the 
presence of a hemodynamically significant restenosis (≥ 50%), as determined by angiography. 
Serious Adverse Event (SAE) 
 
An Adverse Event is considered serious if the event led, or might have led, to one of the following 
outcomes: 
x Death of a subject 
x Serious deterioration in the health of a subject that resulted in any of the following: 
o Life-threatening illness or injury 
o Permanent impairment of a body structure or body function 
o Hospitalization or prolongation of patient hospitalization 
o Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or body function  
o Chronic disease 
x Foetal distress, foetal death or a congenital physical or mental impairment or birth defect 
Note: Planned hospitalizations for pre-existing conditions or a procedure required by this protocol 
without serious deterioration in health is not considered a serious adverse event. 
 
Target Lesion Revascularization (TLR) 
 
Target lesion revascularization is defined as any repeat PCI of the target lesion or bypass surgery of 
the target vessel performed for restenosis or other complication of the target lesion. 

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Target vessel revascularization (TVR) 
 
Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass 
of any segment of the target vessel including the target lesion. 
Target Lesion 
 
Stent placed in a native epicardial coronary vessel with visually estimated nominal vessel diameter of 
≥ 2.0mm and ≤ 3.5mm 
Vascular Complications 
 
Access Site Occlusion: 
 
Access site occlusion is defined as total obstruction of the artery usually by thrombus (but 
may have other causes) usually at the site of access requiring surgical repair. 
 
Arteriovenous Fistula 
 
AV Fistula is defined as a connection between the access artery and the accompanying vein 
that is demonstrated by angiography or ultrasound and most often characterized by a 
continuous bruit. Indicate whether an arteriovenous (AV) Fistula occurred at the site of 
percutaneous entry during the procedure or after lab visit but before any subsequent lab 
visits. 
Pseudoaneurysm 
 
Pseudoaneurysm is defined as the occurrence of a disruption and dilation of the arterial wall 
without identification of the arterial wall layers demonstrated by angiography or ultrasound. 
The location of the pseudoaneurysm should be indicated. 
 
 
 

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TP1125 Revision A 
 
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APPENDIX C: INFORMED CONSENT: FRM1120 
(Note: the document included or referenced in this appendix is a controlled document; the version 
included in this appendix may not be the most recent version.  Contact the Sponsor or site coordinator for 
confirmation of most current revision). 
 
 

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Chansu Vascular Technologies Everolimus Drug Coated Percutaneous Transluminal 
Coronary Angioplasty Catheter First in Human Clinical Investigation: 
A Clinical Evaluation of the Everolimus CVT-PTCA-DCB in the Treatment of Patients with In-Stent 
Restenosis of previously treated Coronary Artery Lesions:  
The CVT-ISR Trial  
INFORMED CONSENT 
INTRODUCTION 
In this consent form, “you” always means the study participant. If you are a legally authorized 
representative, please remember that “you” means the study participant. 
WHY AM I BEING ASKED TO BE IN THIS STUDY? 
You are being asked to be in a study that involves clinical research. Being in this study is 
voluntary. Before you decide if you would like to be in the study, it is important you understand 
why the study is being conducted and what it will involve. Please read this form carefully and 
ask your doctor if you have any questions. Upon reading this form and asking any questions you 
have; you will sign and date the last page of this form if you decide to be in this study. 
You are being asked to be in this study because your doctor recommends that you get a Drug-
Coated Balloon angioplasty treatment, to open an in-stent restenosis in one of your coronary 
arteries which already has been treated previously without the desired results. 
The heart muscle, like every other organ or tissue in your body, needs oxygen-rich blood to 
survive. Blood is supplied to the heart by its own vascular system, called coronary circulation. 
The aorta (the main blood supplier to the body) branches off into two main coronary blood 
vessels (also called arteries). These coronary arteries branch off into smaller arteries, which 
supply oxygen-rich blood to the entire heart muscle. Narrowing of these arteries by 
atherosclerosis or other diseases is called stenosis of the coronary arteries. Restenosis is the 
recurrence of a narrowing in an artery, which has been treated earlier. When a stent is used and 
restenosis occurs, this is called in-stent restenosis or ISR. 
To open the narrowed or blocked coronary arteries, a long, thin tube called a catheter will be 
used that has a small balloon on its tip, which is coated with an anti-proliferative medication. The 
medication aims to prevent the formation of scar tissue in the coronary artery thereby minimizing 
the risk for a new stenosis. The catheter will be inserted into a blood vessel in the groin or wrist 
until it reaches the narrowed or blocked portion of the artery. The balloon will be inflated at the 
blockage site in the artery to flatten or compress the plaque against the artery wall and to deliver 
the medication on the balloon surface to the artery wall and surrounding tissue. This procedure is 
called angioplasty or percutaneous transluminal coronary angioplasty (PTCA). 
The Chansu Vascular Technologies (CVT) Everolimus-coated PTCA Catheter being used in this 
study is investigational because the safety and efficacy of the device are not sufficiently known 
yet to allow commercial certification. The device is a combination of technologies that are 
already commercially available separately (the catheter and the medication). 
STUDY PURPOSE: 

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The purpose of this study is to evaluate the clinical safety and efficacy of the CVT Everolimus-
coated PTCA Catheter in the treatment of in-stent restenosis (ISR) previously treated with a 
drug-eluting or bare metal stent in one of your coronary arteries. 
SYSTEM DESCRIPTION: 
The CVT Everolimus-coated PTCA Catheter is a PTCA system that contains an anti-
proliferative medication. The product consists of a catheter with a drug-coated balloon at the tip. 
The medication will reduce the occurrence of restenosis. The CVT Everolimus-coated PTCA 
Catheter, is considered an investigational device and is not market-released in Europe or 
anywhere else. This means that the effectiveness and safety of the investigational device needs to 
be evaluated before the device will be commercially released. The CVT Everolimus-coated 
PTCA Catheter leverages two existing technologies which both are already commercially 
released. Thereby the new CVT Everolimus-coated PTCA Catheter combines the advantages of 
both technologies into a new Coronary Drug-Coated Balloon Catheter system. 
This study with the CVT Everolimus-coated PTCA Catheter is approved by the Medical Ethics 
Committee of insert name of committee. It is being performed in accordance with the national 
and international legal requirements. 
HOW LONG WILL I BE IN THE STUDY? HOW MANY PEOPLE WILL BE IN THE 
STUDY? 
About 50 subjects will be enrolled in this study in Europe. Your participation in the study may 
last about 36 months. The study will be conducted for a minimum of 36 months from treatment 
of the final subject, and it is expected that 50 patients can be enrolled in the study in 
approximately 9 months. This means that the overall study duration is expected to last a total of 
45 months. 
WHAT ARE MY RESPONSIBILITIES DURING THE STUDY? 
Being in this study, it is important that you: 
x 
Tell the study doctor about your medical and medication history. 
x 
Attend all visits scheduled with the study doctor. 
x 
Call the study doctor’s office to reschedule a missed visit as soon as possible. 
x 
Report any injuries, hospitalizations, emergency room visits, symptoms or complaints to 
the study doctor or nurse as soon as possible. 
x 
Keep your contact information up to date (address, telephone number, etc.). 
x 
Are compliant with the study procedures and the medications that your doctor prescribes. 
WHAT WILL HAPPEN IF I AM IN THIS STUDY? 
If you decide to be in this study, the study doctor and study nurse will collect information about 
you and your medical history. This includes any medication you currently take and any other 
information in your medical records related to your condition or treatment that may be relevant 
to you being in the study. 

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To determine if the CVT Everolimus-coated PTCA Catheter is a good treatment choice for you, 
a screening will take place. 
The screening will be performed by a qualified member of the research team and the hospital. 
During the screening it will be determined if you meet the eligibility criteria to be included in 
this study. Your medical and cardiac history will be checked and an existing angiogram (X-ray 
imaging of your heart's blood vessels) will be analyzed as well to determine if an angioplasty can 
be performed successfully. 
If your study doctor decides you are suitable for the study, you will receive the angioplasty with 
the CVT Everolimus-coated PTCA Catheter. However, after the screening your study doctor 
may decide that you are not suitable for the study or it is not possible to receive the angioplasty 
with the CVT Everolimus-coated PTCA Catheter. In that case you may receive another treatment 
which is best to treat your condition and you will not participate in the study. 
STUDY PROCEDURES: 
For this study, your study doctor will schedule 2 follow-up visits with you after the procedure 
has taken place and you will also receive 3 phone calls. You must make sure that you can come 
to each visit as scheduled or respond to emails or be available for a phone call follow-up. 
BASELINE: PRIOR TO THE BALLOON ANGIOPLASTY PROCEDURE 
Prior to your procedure the following will be collected/performed: 
• 
You will be asked questions about your medical history; including your cardiac history. 
• 
You will be asked questions to check your medical status. 
• 
You will have routine laboratory tests done within 7 days before your planned Balloon Angioplasty 
Procedure. About 10-20 ml (about 2-4 teaspoons) of blood will be drawn within 72 hours before your 
Balloon Angioplasty Procedure. This is done to measure your blood count for any blood clotting 
problems, for possible infection and to look at your cardiac biomarkers (a substance released from the 
heart muscle). Tests will check to see that no damage has been done to your heart muscle. Tests will 
also check the function of your kidneys. These tests are routine when having a PTCA procedure. The 
blood draws can cause some pain from the needle stick and bruising at the site of the blood draw. 
• 
An Electrocardiogram (ECG) will be done to record the electrical activity of your heart. 
• 
If you are female and of child-bearing potential, a pregnancy test may be done within 14 days before  
your procedure to confirm you are not pregnant. If you are pregnant you will be exited from this 
study. You must be willing to use a reliable method of contraception for the entire duration of study 
participation. 
• 
Antiplatelet Medications will be given within 24 hours before your procedure. It is routine to take 
medication before your procedure. Antiplatelet medicines help prevent blood clots from forming. This 
includes aspirin and medicine, such as clopidogrel (Plavix®), ticlopidine (Ticlid®), prasugrel 
(Effient®), or ticagrelor (Brilinta®). 
BALLOON ANGIOPLASTY PROCEDURE VISIT 
Your balloon angioplasty procedure will be done following standard procedures at the study site. 

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The study doctor will perform an angiogram. It is a procedure that uses contrast dye and x-ray to 
allow the study doctor to see inside the arteries. The angiogram requires catheters to be placed 
into your arteries to allow injection of a special contrast dye which can be seen on x-ray. The x-
ray machine then takes pictures of the arteries (angiography) that show your study doctor where 
the blockage is and how severe the blockage is. He uses angiography to decide whether the 
narrowed artery is usable for the study. If you will be treated with the study device, the 
procedure will be recorded by x-ray filming of the artery and a copy will be used for analysis. 
At the time of the angiogram, the study doctor may perform an Intravascular Ultrasound (IVUS 
= device using sound waves to see inside blood vessels) or an optical coherence tomography 
(OCT = device using infrared light to see inside blood vessels) if the hospital has one or the other 
device. These devices provide more precise information regarding the coronary artery which has 
been treated. 
If you do not meet the requirements for this study, you may receive treatment with a different 
market approved coronary balloon or other treatment. If that happens, you will not be considered 
to be participating in the study and will not be followed in the study. Your doctor will follow up 
with you as part of your standard care.  
DISCHARGE (BEFORE YOU LEAVE THE HOSPITAL AFTER THE ANGIOPLASTY 
PROCEDURE) 
After the balloon angioplasty procedure, the following will be collected/performed: 
x 
Lab tests will be done within the 24 hours after your procedure. About 10-20 ml of blood (about 
2-4 teaspoons) will be drawn to look at your health status and cardiac biomarkers. Other blood 
may be drawn if more monitoring is needed. 
x 
An ECG will be done within 24 hours after your procedure to record the electrical activity of your 
heart. 
x 
Antiplatelet Medications – It is routine to take medicine after the procedure. Antiplatelet 
medicines help prevent blood clots in your coronary arteries. Antiplatelet medicine will be 
prescribed to you, at an amount that is best for you, after the procedure for at least six months. 
Your study doctor will ask you to take aspirin indefinitely. 
It is very important you take all of the medicine as you are told by the study doctor and that you 
do not stop taking any medicine without first talking to the study doctor or study staff. It is also 
important to understand how missing any doses or not taking these medicines may affect you. 
Stopping the prescribed antiplatelet medication earlier than instructed by the study doctor could 
result in a higher risk of blood clots, heart attack or death. 
FOLLOW-UP AT 6 MONTHS: 
At this follow-up the following will be collected/performed: 
x 
Physical examination 
x 
ECG 
x 
You will be asked if you have had any problems or symptoms since your last visit 
x 
Antiplatelet medications will be evaluated 

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You may be selected for an angiographic follow up and angiogram of your coronary arteries. 
You will be informed about this at the time of the procedure. These angiographic images will be 
reviewed to check the efficacy of the procedure. 
At the time of the angiogram, the study doctor may perform an IVUS or an OCT if the hospital 
has one or the other device. The images obtained from these devices will be reviewed to check 
the efficacy of the procedure as well. 
FOLLOW-UP AT 12 MONTHS: 
At this follow-up, the following will be collected/performed: 
x 
 Physical examination 
x 
 ECG 
x 
 You will be asked if you have had any problems or symptoms since your last visit. 
x 
Antiplatelet Medications will be evaluated 
FOLLOW-UP AT 30 DAYS, 24 MONTHS, AND AT 36 MONTHS: 
At these follow-up times, you will be contacted by phone and you will have to answer a series of 
questions about your medical status, the antiplatelet medication you are taking and you will be 
asked if you have had any problems or symptoms since your last visit or phone call. 
 
 

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SUMMARY TABLE OF EXAMINATIONS AND PROCEDURES BASED ON VISIT 
DATES 
VISIT WINDOW/PERIOD 
(The day of the ablation procedure is Day 
0, so all of the follow-up visit windows are 
determined from this date) 
DESCRIPTION OF THE SUBJECT VISIT 
Screening and enrollment visit(s) in the 
14 days prior to the ablation procedure 
Signature of the consent form, physical 
examination, laboratory tests, ECG, chronic 
concomitant medications, 
antiplatelet/anticoagulant medications.  
Day of discharge from the hospital 
Physical examination, laboratory tests, ECG, 
chronic concomitant medications, 
antiplatelet/anticoagulant medications, 
occurrence of problems or symptoms since the 
procedure. 
Follow-up visit at 30 days ± 7 days 
Phone contact or site visit / assessment of your 
medical status, antiplatelet medications / 
occurrence of problems or symptoms since the 
last visit. 
Follow-up visit at 180 (6 months) ± 30 days 
Physical examination / ECG / coronary 
angiogram / chronic concomitant medications, 
antiplatelet/anticoagulant medications / 
occurrence of problems or symptoms since the 
last phone call. 
Follow-up visit at 365 (12 months) ± 30 days Physical examination / ECG / chronic 
concomitant medications, 
antiplatelet/anticoagulant medications / 
occurrence of problems or symptoms since the 
last visit. 
Follow-up visit at 24 months (± 30 days) 
Phone contact / assessment of your medical 
status, antiplatelet medications / occurrence of 
problems or symptoms since the last visit. 
Follow-up visit at 36 months (± 30 days) 
Phone contact / assessment of your medical 
status, antiplatelet medications / occurrence of 
problems or symptoms since the last phone call. 
It is very important that the study staff is able to contact you at each of the time points to collect 
the required study data. If the study staff is not able to reach you at one of these time points, they 
may contact a relative, a person whom you have provided contact details for or your regular 
doctor. 
By signing the Consent Form for this study, you agree to allow the people listed above to be 
contacted if you cannot be reached.  

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You will be exited from the study after completing your 36 month visit and you will continue to 
receive standard care from your doctor. 
WHAT ARE THE POSSIBLE RISKS, SIDE-EFFECTS AND INCONVENIENCES? 
Since the CVT Everolimus-coated PTCA Catheter is an investigational device, the risks are not 
entirely known but are believed to be similar to those that are associated with the standard, 
customary angioplasty with a commercially available drug-coated balloon of a stenosed coronary 
artery. The risks associated with using this device are related to the drug, and risks associated 
with standard percutaneous coronary diagnostic and treatment procedures. 
All efforts will be made to minimize the risks in this study by selecting doctors who are 
experienced and skilled in interventional procedures including stenting, by clearly defining 
inclusion/exclusion criteria to ensure only appropriate patients are enrolled, and by ensuring that 
treatment and follow-up of the patient are consistent with current medical practices. 
EVEROLIMUS AND BALLOON COATING 
The balloons are coated with a drug called Everolimus. Potential side-effects unique to the 
Everolimus drug coating may include: 
x Abdominal pain  
x Anemia (the body does not get enough oxygen rich blood) 
x Angioedema (rapid swelling of the skin and mucous membranes, sometimes affecting the 
face and throat) 
x Anorexia (loss of appetite) 
x Asthenia (physical weakness or lack of energy) 
x Constipation 
x Cough 
x Delayed wound healing/fluid accumulation 
x Diarrhea 
x Dry Skin 
x Dyslipidemia (abnormal level of fats in the blood) including hyperlipidemia (abnormally 
elevated level of fats in the blood) and hypercholesterolemia (abnormally elevated level of 
cholesterol in the blood) 
x Dyspnea (shortness of breath) 
x Dysgeusia (condition where perception of taste is altered) 
x Dyspepsia (indigestion) 
x Dysuria (painful or difficult urination) 
x Edema (excess fluid in the tissues) 

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x Epistaxis (nosebleeds) 
x Fatigue 
x Headache 
x Hematuria (blood in the urine) 
x Hyperglycemia (abnormally high blood sugar) 
x Hyperkalemia (abnormally high level of potassium in the blood) 
x Hyperlipidemia (abnormally high concentration of fats or lipids in the blood) 
x Hypertension (abnormally high blood pressure) 
x Hypokalemia (abnormally low level of potassium in the blood) 
x Hypomagnesemia (abnormally low level of magnesium in the blood) 
x Hypophosphatemia (abnormally low level of phosphate in the blood) 
x Increased serum creatinine (sign of poor kidney function) 
x Infections and Serious Infections: bacterial, viral, fungal, and protozoal infections (infectious 
disease caused or transmitted by a parasite) 
x Insomnia 
x Interaction with strong inhibitors and inducers of CYP3A4 or PgP (interaction of everolimus 
with specific substances of the organism could reduce the efficacy of some pharmaceutical 
drugs) 
x Leukopenia (decrease in the number of leucocytes [colorless cell that circulates in the blood 
and body fluids and involved in counteracting foreign substances and disease]) 
x Lymphoma (cancer of the lymphatic system, which is part of the body's germ-fighting 
network) and other malignancies (including skin cancer) 
x Male infertility 
x Mucosal inflammation including oral ulceration and oral mucositis (inflammation and/or 
ulceration of the oral mucosal membranes) 
x Nausea 
x Neutropenia (decrease in the number of neutrophils [a type of white blood cell that helps heal 
damaged tissues and resolve infections]) 
x Non-Infectious pneumonitis (noninfectious general inflammation of lung tissue) 
x Pain: extremity, incision site and procedural, and back 
x Proteinuria (elevated levels of protein in urine) 
x Pruritus (itch) 
x Pyrexia (fever) 

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x Rash (abnormal changes in skin color or texture) 
x Stomatitis (inflammation of the mouth and lips) 
x Thrombocytopenia (abnormally low number of thrombocytes [platelets] in the blood, which 
increases the risk of bleeding) 
x Thrombotic microangiopathy (destruction of red blood cells and organ damage due to the 
formation of microscopic blood clots in capillaries and small arteries) 
x Thrombotic thrombocytopenic purpura (blood disorder that results in blood clots forming in 
small blood vessels throughout the body) 
x Tremor 
x Urinary tract infection  
x Upper respiratory tract infection 
x Vomiting 
PERCUTANEOUS CORONARY DIAGNOSTIC AND TREATMENT PROCEDURES 
Other risks associated with using this device are those associated with the treatment procedures. 
These risks may include the following: 
x Acute myocardial infarction also known as heart attack (a blood clot in the vessels that 
supply blood to your heart that causes part of the heart muscle to die) 
x Aneurysm (enlarged part of a blood vessel caused by a weakening of the artery wall) 
x Arrhythmias (irregular heartbeat) including ventricular fibrillation (situation when the 
ventricles merely quiver and do not contract in a coordinated way), Bradycardia (slower than 
normal heart rate) and Tachycardia (faster than normal heart rate) 
x Arterial dissection (a tear within the wall of a blood vessel, which allows blood to separate 
the wall layers) 
x Arteriovenous fistula (an abnormal connection between an artery and a vein) 
x Bleeding 
x Coronary artery spasm (a brief, sudden narrowing of one of the blood vessels supplying 
blood and oxygen to the heart) 
x Coronary artery thrombosis (formation of a blood clot inside a blood vessel of the heart) 
x Death (Cardiovascular or non-cardiovascular related) 
x Discomfort during the procedure 
x Drug reactions or allergic reactions to contrast medium (a substance used to enhance the 
visibility of blood vessels) 
x Distal Embolism of air (migration of one or more bubbles of air downstream of the blood 
vessel), thrombus (migration of blood clot downstream of the blood vessel), plaque (fatty 
deposits downstream of the blood vessel) / Device Embolism (migration of device or parts of 

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device used during the treatment procedure in the blood vessel) 
x Endocarditis (inflammation of the inner lining of your heart's chambers and valves) 
x Fever 
x Groin Bruising/Discomfort 
x Hematoma (bruising) 
x Hemorrhage (bleeding) 
x Hypertension (abnormally high blood pressure) 
x Hypotension (abnormally low blood pressure) 
x Injury at blood vessel access site requiring surgical or medical treatment 
x Ischemia (vascular disease involving an interruption in the arterial blood supply to a tissue, 
organ, or extremity that, if untreated, can lead to tissue death) 
x Pseudoaneurysm (false aneurysm; a collection of blood that forms between the inner and 
outer layer of a blood vessel, usually caused by an injury to the vessel) 
x Renal failure (condition in which the kidneys are no longer able to filter and clean blood) 
x Restenosis of the dilated vessel (re-narrowing of the blood vessel that received treatment to 
clear the blockage) 
x Sepsis (blood infection) 
x Stroke or cerebrovascular event (sudden death of brain cells in a localized area due to not 
enough blood flow) 
x Total occlusion (no more blood flow possible in the blood vessel) of the coronary artery or 
bypass graft (blood vessel removed from another area of the body to bypass narrowed heart 
arteries) 
x Unstable angina (pain in the chest) 
x Vessel dissection (a tear within the wall of a blood vessel, which allows blood to separate the 
wall layers), perforation (a leak in the wall of a blood vessel), rupture (broken blood vessel) 
or injury 
x Thrombosis (formation of blood clots in blood vessels) 
x Vomiting/Nausea 
FOLLOW-UP ANGIOGRAPHY PROCEDURES: 
The risks associated with the follow-up angiography procedures may include the following: 
x Acute myocardial infarction also known as heart attack (a blood clot in the vessels that 
supply blood to your heart that causes part of the heart muscle to die) 
x Arrhythmias (irregular heartbeat) including ventricular fibrillation (situation when the 
ventricles merely quiver and do not contract in a coordinated way), Bradycardia (slower than 

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FRM1120 Rev. A, DCO#0034.  Effective Date: 01-Jun-2021.                                       Page 11 of 17 
 
normal heart rate) and Tachycardia (faster than normal heart rate) 
x Arteriovenous fistula (an abnormal connection between an artery and a vein) 
x Coronary artery spasm (a brief, sudden narrowing of one of the blood vessels supplying 
blood and oxygen to the heart) 
x Death (Cardiovascular or non-cardiovascular related) 
x Drug reactions or allergic reactions to contrast medium (a substance used to enhance the 
visibility of blood vessels) 
x Hematoma (bruising) 
x Hypertension (abnormally high blood pressure) 
x Hypotension (abnormally low blood pressure) 
x Infection at access site 
x Pain and tenderness 
x Pseudoaneurysm (false aneurysm; a collection of blood that forms between the inner and 
outer layer of a blood vessel, usually caused by an injury to the vessel) 
x Restenosis of the dilated vessel (re-narrowing of the blood vessel that received treatment to 
clear the blockage) 
x Stroke (sudden death of brain cells in a localized area due to not enough blood flow), air 
embolism (migration of one or more bubbles of air in the circulatory system), and 
embolization or fragmentation of thrombotic or artherosclerotic material (a blood clot or 
plaque dislodged from the blood vessel and becomes free-floating in the circulatory system 
with the risk of blocking a blood vessel supplying the brain) 
x Total occlusion (no more blood flow possible in the blood vessel) of the coronary artery or 
bypass graft (blood vessel removed from another area of the body to bypass narrowed heart 
arteries) 
x Unstable angina (pain in the chest) 
x Vessel dissection (a tear within the wall of a blood vessel, which allows blood to separate the 
wall layers), perforation (a leak in the wall of a blood vessel), rupture (broken blood vessel) 
or injury 
RADIATION RISKS: 
As a result of your participation in this study, you will be exposed to radiation from x-ray 
procedures. In addition to the routine procedures you will undergo, the x-ray exams used for this 
study include a required angiographic evaluation of the CVT Everolimus-coated PTCA Catheter 
at 6 months follow-up. These x-ray exams deliver up to a total radiation dose of approximately 5 
milliSievert (mSv). A milliSievert is a unit of radiation dose. For comparison, the average person 
in Europe receives 1.8 mSv each year from natural sources of radiation. A slight increase in 
cancer risk may exist for people exposed to radiation. The dose from this procedure is 
comparable to that received from many diagnostic medical x-ray and nuclear medicine 

C V  T  Protocol Number: TP1125                                                             The CVT-ISR Trial 
FRM1120 Rev. A, DCO#0034.  Effective Date: 01-Jun-2021.                                       Page 12 of 17 
 
procedures. At this dose level, no harmful effects of radiation have been demonstrated, as any 
effect is too small to measure. 
Following the fluoroscopic procedure, the skin area exposed to the x-rays could react to produce 
an effect similar to a sun burn. A skin reaction, if it occurs at all, could show up from a few hours 
to a few weeks after the procedure, and usually goes away on its own. If you have a skin 
reaction, you should promptly report this to your study doctor. 
If you are or you become pregnant, there may be risks to you or your unborn child that are not 
yet known. 
There may be additional risks related to this study that are not yet known. 
WHAT ARE THE POSSIBLE BENEFITS OF THE STUDY? 
If you agree to be in this study, it is possible that you may not have any direct medical benefits. 
The information from this study may benefit other subjects with similar conditions in the future. 
WHAT HAPPENS WHEN I END BEING IN THE STUDY? 
When you end being in this study, you will continue to receive standard care from your doctor. 
WHAT OTHER TREATMENT CHOICES DO I HAVE IF I AM NOT IN THE STUDY? 
You do not have to be in this study to be treated for coronary artery disease. 
If you decide not to be in this study, there is other care available to you. You will be treated in 
other ways, for example, treatment with another commercially available coronary drug-coated 
balloon or a stent. You may choose no treatment at all. You should discuss other treatments and 
their possible risks and benefits with your doctor. 
WHO IS PAYING FOR THIS STUDY? 
The site will receive payment from CVT for work involved in collecting study data and 
managing the study at the site. Being in this study may contribute to the development of 
commercial products from which CVT may receive economic benefit. 
WILL I BE PAID FOR BEING IN THIS STUDY? 
You will not receive any compensation for your participation in this study. 
WHAT WILL I HAVE TO PAY FOR IF I AM IN THIS STUDY? 
Testing and services done only for the study will be provided at no cost to you. All costs that are 
part of your usual medical care that would have been provided if you were not in the study will 
be covered by your medical insurance. 
In the event of physical injury or physical illness resulting from your participation in this study, 
any immediate medical treatment you need will be provided. 
Your name of national healthcare coverage should cover the costs of medical care and treatment. 
WHAT HAPPENS IF I AM INJURED OR HURT DURING THIS STUDY? 

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In the event of physical injury or physical illness resulting from your participation in this study, 
any immediate medical treatment you need will be provided. The study sponsor, CVT has agreed 
to pay back the site for the costs of medical or surgical care it provides for any illness or injury 
related to your participation in the study, if the treatment is not already covered by your medical 
insurance. 
By agreeing to this, you do not give up any of your legal rights. You do not release CVT, study 
doctors, or the hospital from responsibility for their negligence. 
DO I HAVE THE RIGHT TO REFUSE TO BE IN THIS STUDY OR TO LEAVE THIS 
STUDY? 
Being in this study is voluntary. You may choose not to be in the study or to leave the study at 
any time for any reason. If you choose not to be in the study or to leave the study, this will not 
result in any penalty and you will not lose any benefits to which you are entitled. Your regular 
care and your relationship with the hospital or clinic and your doctors will not be affected. 
You will be told about any new information that may make you change your mind about staying 
in the study. You may be asked to sign a new consent form if this occurs. 
You may leave the study simply by telling the study doctor. There are no specific tests that are 
required prior to leaving the study. You may be asked to come in for a final product check or 
visit. 
The study doctor may take you out of the study without your permission if: 
x 
It is in your best medical interest 
x 
You do not follow your study doctor’s instructions 
x 
The study sponsor or regulatory authority stops the study 
If this happens you will be notified about being removed from the study and you will be 
provided with an explanation about such decision. 
All of your health data already collected for the study can still be used by the study sponsor 
unless you object and ask for deletion of the data. 
WHAT IS THE ROLE OF THE STUDY SPONSOR’S REPRESENTATIVE? 
Trained CVT personnel may be present at the intervention and at study follow-up visits. The role 
of the CVT person is to give technical support. All of these actions will be done under the careful 
direction of your study doctor. 
HOW WILL THE STUDY SPONSOR USE THE STUDY INFORMATION? 
Your participation in this study is entirely confidential to the extent allowed by law. If you are in 
this study, the following data will be collected by the study team: 
x 
Identifying data (name, age, address). 
x 
Medical and health data from your medical records. 
x 
Data on your living habits. 
x 
Identifying biological samples taken from you. (hereinafter called “personal data”) 

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Your personal data will be processed at all times in accordance with applicable legal 
requirements. 
In general only the study doctor and/or nurse as well as the study monitor who acts on behalf of 
CVT have direct access to your personal data in your subject file. Furthermore it may happen 
that members of the Ethics Committee and representatives of national, European or other 
international public authorities are granted direct access to your personal data in order to comply 
with legal requirements. 
For conducting the study your personal data will be transferred to and processed by CVT or a 
third party designated by CVT - but solely in a key coded form. This means that your data will 
be transferred to CVT or a third party designated by CVT which is located in your country, in a 
member state of the European Economic Area but maybe also in the United States or another 
country where the European Directive on Data Protection does not apply. 
CVT may also use your personal data for additional purposes such as overseeing and improving 
the performance of its product, new medical research, developing new medical products or 
procedures, and other business purposes. 
You are entitled to access the personal data collected about you and to have inaccuracies 
corrected. 
Any published information including reports and articles about the study will not include your 
name or any information that could personally identify you. Information received during the 
study will not be used to market to you; your name will not be placed on any mailing lists or sold 
to anyone for marketing purposes. 
You may change your mind and take back this permission to continue collecting your personal 
data at any time. To take back this permission, you will need to write to insert name and contact 
information. However, if you take back this permission, you will no longer be a participant in the 
study. All of your personal data that was already collected will still be used unless you object and 
ask for deletion of data. 
WHERE CAN I FIND OUT ABOUT THE STUDY RESULTS? 
A description of this study will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This website will not include information that can identify you. At most, the website 
will include a summary of the results. You can consult the general outcome and results of this 
study after they have been made publicly available by consulting this website. 
WHO CAN I CALL WITH QUESTIONS, COMPLAINTS OR IF I’M CONCERNED 
ABOUT MY RIGHTS AS A PARTICIPANT? 
If you have any questions about the research or being in this study, you should contact insert 
name at insert telephone number. 
 
If you think you have a research-related injury, you should contact insert name at insert telephone 
number. 
If you have any questions about your rights as a participant you should contact insert name at 
insert telephone number. 

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WHO HAS REVIEWED THE STUDY? 
This study was reviewed and approved by the insert name of committee Research Ethics Committee. 

C V  T  Protocol Number: TP1125                                                             The CVT-ISR Trial 
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INFORMED CONSENT FOR THE CVT_ISR CLINICAL STUDY 
 
SUBJECT INFORMED CONSENT FORM SIGNATURE SHEET 
x 
I have read the subject information for this study and my study doctor has answered all my 
questions regarding the study. 
x 
I had sufficient time to consider my participation in this study, I am aware that participation 
in this study is completely voluntary, and I agree to follow the instructions from the study 
doctor. 
x 
I realize that I may decide to refuse participation or stop participation at any time without 
penalty and without affecting the quality of my health care or the relationship with my study 
doctor. 
x 
I understand and agree that personal information about me will be collected from my medical 
records, used and processed (manually and by computer) by the manufacturer of a product 
used in my treatment or any other designated party that is involved in the study (e.g., 
hospital, study doctor, regulatory authorities, ethics committees). 
x 
I understand and agree that representatives from CVT, regulatory authorities and the Ethics 
Committee will be granted direct access to my medical records. 
x 
I understand and agree that the study doctor(s)/hospital will release the relevant personal 
information about me for the purpose of the study. 
x 
I understand that I am entitled to access the personal information collected about me and to 
have inaccuracies corrected. 
x 
I agree to voluntarily be in and comply with this study. 
x 
I understand that I will receive a dated and signed copy of the subject informed consent form. 
 
It is your choice if you would like your personal physician to be informed of 
your participation in this study. Please check one of the boxes below to show 
your choice: 
 I agree to inform my personal doctor about my participation in this study. 
 I do not agree to inform my personal physician about my participation in the 
study. 

C V  T  Protocol Number: TP 1109  
 
                                The CVT-SFA Trial 
 
FRM1120 Rev. A, DCO#0034.  Effective Date: 01-Jun-2021.                                    Page 17 of 17 
 
Signature of the subject  
I agree to be in this study, and I have consented before the initiation of any study 
specific procedures. 
 
Name: ________________________________________________________ 
Signature: _____________________________________________________ 
Date: (DD/MM/YYYY) __________________________________________________ 
 
Study doctor or designated person by study doctor: 
I have conducted the informed consent discussion. 
Name: ________________________________________________________ 
Signature: _____________________________________________________ 
Date: (DD/MM/YYYY) __________________________________________ 
 
If subject is unable to read: 
I have attended the entire informed consent discussion. I attest that the information in 
the consent form and any other written information was accurately explained to, and 
apparently understood by, the subject. Informed consent was freely given by the 
subject. 
Impartial Witness Name: _________________________________________ 
Signature: ______________________________________________________ 
Date: (DD/MM/YYYY)_____________________________________________ 
 

Chansu Vascular Technologies, LLC 
The CVT-ISR Trial 
TP1125 Revision A 
 
CONFIDENTIAL 
Page 59 of 74 
 
APPENDIX D:  DECLARATION OF HELSINKI 
(4 pages) 
 
 

Chansu Vascular Technologies, LLC 
The CVT-ISR Trial 
TP1125 Revision A 
 
CONFIDENTIAL 
Page 60 of 74 
 
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI 
Ethical Principles for Medical Research Involving Human Subjects 
 
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by  
the 29th WMA General Assembly, Tokyo, Japan, October 1975, 35th WMA General Assembly, Venice, 
Italy, October 1983, 41st WMA General Assembly, Hong Kong, September 1989, 48th WMA General 
Assembly, Somerset West, Republic of South Africa, October 1996 and the 52nd WMA General 
Assembly, Edinburgh, Scotland, October 2000. 
Note of Clarification on Paragraph 29 added by the WMA General Assembly, Washington 2002  
Note of Clarification on Paragraph 30 added by the WMA General Assembly, Tokyo 2004  
A.   
INTRODUCTION  
1.  
The World Medical Association has developed the Declaration of Helsinki as a statement of 
ethical principles to provide guidance to physicians and other participants in medical research 
involving human subjects. Medical research Involving human subjects includes research on 
identifiable human material or identifiable data.  
2.  
It is the duty of the physician to promote and safeguard the health of the people.  
The physician's knowledge and conscience are dedicated to the fulfillment of this duty.  
3.  
The Declaration of Geneva of the World Medical Association binds the physician with the 
words, "The health of my patient will be my first consideration," and the International Code of 
Medical Ethics declares that, "A physician shall act only in the patient's interest when providing 
medical care which might have the effect of weakening the physical and mental condition of the 
patient."  
4.  
Medical progress is based on research which ultimately must rest in part on experimentation 
involving human subjects.  
5.  
In medical research on human subjects, considerations related to the well-being of the human 
subject should take precedence over the interests of science and society.  
6.  
The primary purpose of medical research involving human subjects is to improve prophylactic, 
diagnostic and therapeutic procedures and the understanding of the aetiology and pathogenesis 
of disease. Even the best proven prophylactic, diagnostic, and therapeutic methods must 
continuously be challenged through research for their effectiveness, efficiency, accessibility and 
quality.  
7.  
In current medical practice and in medical research, most prophylactic, diagnostic and 
therapeutic procedures involve risks and burdens.  
8.  
Medical research is subject to ethical standards that promote respect for all human beings and 
protect their health and rights. Some research populations are vulnerable and need special 
protection. The particular needs of the economically and medically disadvantaged must be 
recognized. Special attention is also required for those who cannot give or refuse consent for 
themselves, for those who may be subject to giving consent under duress, for those who will not 
benefit personally from the research and for those for whom the research is combined with care.  

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TP1125 Revision A 
 
CONFIDENTIAL 
Page 61 of 74 
 
9.  
Research Investigators should be aware of the ethical, legal and regulatory requirements for 
research on human subjects in their own countries as well as applicable international 
requirements. No national ethical, legal or regulatory requirement should be allowed to reduce or 
eliminate any of the protections for human subjects set forth in this Declaration.  
B.  
BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH  
10.   
It is the duty of the physician in medical research to protect the life, health, privacy, and dignity 
of the human subject.  
11.   
Medical research involving human subjects must conform to generally accepted scientific 
principles, be based on a thorough knowledge of the scientific literature, other relevant sources 
of information, and on adequate laboratory and, where appropriate, animal experimentation.  
12.   
Appropriate caution must be exercised in the conduct of research which may affect the 
environment, and the welfare of animals used for research must be respected.  
13.   
The design and performance of each experimental procedure involving human subjects should 
be clearly formulated in an experimental protocol. This protocol should be submitted for 
consideration, comment, guidance, and where appropriate, approval to a specially appointed 
ethical review committee, which must be independent of the investigator, the sponsor or any 
other kind of undue influence. This independent committee should be in conformity with the 
laws and regulations of the country in which the research experiment is performed. The 
committee has the right to monitor ongoing trials. The researcher has the obligation to provide 
monitoring information to the committee, especially any serious adverse events. The researcher 
should also submit to the committee, for review, information regarding funding, sponsors, 
institutional affiliations, other potential conflicts of interest and incentives for subjects.  
14.   
The research protocol should always contain a statement of the ethical considerations involved 
and should indicate that there is compliance with the principles enunciated in this Declaration.  
15.   
Medical research involving human subjects should be conducted only by scientifically qualified 
persons and under the supervision of a clinically competent medical person. The responsibility 
for the human subject must always rest with a medically qualified person and never rest on the 
subject of the research, even though the subject has given consent.  
16.   
Every medical research project involving human subjects should be preceded by careful 
assessment of predictable risks and burdens in comparison with foreseeable benefits to the 
subject or to others. This does not preclude the participation of healthy volunteers in medical 
research. The design of all studies should be publicly available.  
17.   
Physicians should abstain from engaging in research projects involving human subjects unless 
they are confident that the risks involved have been adequately assessed and can be satisfactorily 
managed. Physicians should cease any investigation if the risks are found to outweigh the 
potential benefits or if there is conclusive proof of positive and beneficial results.  
18.   
Medical research involving human subjects should only be conducted if the importance of the 
objective outweighs the inherent risks and burdens to the subject. This is especially important 
when the human subjects are healthy volunteers.  
19.   
Medical research is only justified if there is a reasonable likelihood that the populations in which 
the research is carried out stand to benefit from the results of the research.  
20.   
The subjects must be volunteers and informed participants in the research project.  

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The CVT-ISR Trial 
TP1125 Revision A 
 
CONFIDENTIAL 
Page 62 of 74 
 
21.   
The right of research subjects to safeguard their integrity must always be respected. Every 
precaution should be taken to respect the privacy of the subject, the confidentiality of the 
patient's information and to minimize the impact of the study on the subject's physical and 
mental integrity and on the personality of the subject.  
22.   
In any research on human beings, each potential subject must be adequately informed of the 
aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of 
the researcher, the anticipated benefits and potential risks of the study and the discomfort it may 
entail. The subject should be informed of the right to abstain from participation in the study or to 
withdraw consent to participate at any time without reprisal. After ensuring that the subject has 
understood the information, the physician should then obtain the subject's freely-given informed 
consent, preferably in writing. If the consent cannot be obtained in writing, the non-written 
consent must be formally documented and witnessed.  
23.   
When obtaining informed consent for the research project the physician should be particularly 
cautious if the subject is in a dependent relationship with the physician or may consent under 
duress. In that case the informed consent should be obtained by a well-informed physician who 
is not engaged in the investigation and who is completely independent of this relationship.  
24.   
For a research subject who is legally incompetent, physically or mentally incapable of giving 
consent or is a legally incompetent minor, the investigator must obtain informed consent from 
the legally authorized representative in accordance with applicable law. These groups should not 
be included in research unless the research is necessary to promote the health of the population 
represented and this research cannot instead be performed on legally competent persons.  
25.   
When a subject deemed legally incompetent, such as a minor child, is able to give assent to 
decisions about participation in research, the investigator must obtain that assent in addition to 
the consent of the legally authorized representative.  
26.   
Research on individuals from whom it is not possible to obtain consent, including proxy or 
advance consent, should be done only if the physical/mental condition that prevents obtaining 
informed consent is a necessary characteristic of the research population. The specific reasons 
for involving research subjects with a condition that renders them unable to give informed 
consent should be stated in the experimental protocol for consideration and approval of the 
review committee. The protocol should state that consent to remain in the research should be 
obtained as soon as possible from the individual or a legally authorized surrogate.  
27.   
Both authors and publishers have ethical obligations. In publication of the results of research, the 
investigators are obliged to preserve the accuracy of the results. Negative as well as positive 
results should be published or otherwise publicly available. Sources of funding, institutional 
affiliations and any possible conflicts of interest should be declared in the publication. Reports of 
experimentation not in accordance with the principles laid down in this Declaration should not 
be accepted for publication.  
 
C.  
ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH  
  
MEDICAL CARE  
28.   
The physician may combine medical research with medical care, only to the extent that the 
research is justified by its potential prophylactic, diagnostic or therapeutic value. When medical 
research is combined with medical care, additional standards apply to protect the patients who 
are research subjects.  

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TP1125 Revision A 
 
CONFIDENTIAL 
Page 63 of 74 
 
29.   
The benefits, risks, burdens and effectiveness of a new method should be tested against those of 
the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use 
of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic 
method exists.1  
30.   
At the conclusion of the study, every patient entered into the study should be assured of access to 
the best proven prophylactic, diagnostic and therapeutic methods identified by the study.2  
31.   
The physician should fully inform the patient which aspects of the care are related to the 
research. The refusal of a patient to participate in a study must never interfere with the patient-
physician relationship.  
32.  
In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods do 
not exist or have been ineffective, the physician, with informed consent from the patient, must be 
free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in the 
physician's judgment it offers hope of saving life, re-establishing health or alleviating suffering. 
Where possible, these measures should be made the object of research, designed to evaluate their 
safety and efficacy. In all cases, new information should be recorded and, where appropriate, 
published. The other relevant guidelines of this Declaration should be followed.  
1 Note of clarification on paragraph 29 of the WMA Declaration of Helsinki  
The WMA hereby reaffirms its position that extreme care must be taken in making use of a 
placebo-controlled trial and that in general this methodology should only be used in the absence 
of existing proven therapy. However, a placebo-controlled trial may be ethically acceptable, 
even if proven therapy is available, under the following circumstances:  
-   Where for compelling and scientifically sound methodological reasons its use is necessary to 
determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method; or  
-   Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor 
condition and the patients who receive placebo will not be subject to any additional risk of 
serious or irreversible harm. All other provisions of the Declaration of Helsinki must be 
adhered to, especially the need for appropriate ethical and scientific review.  
2 Note of clarification on paragraph 30 of the WMA Declaration of Helsinki  
The WMA hereby reaffirms its position that it is necessary during the study planning process to 
identify post-trial access by study participants to prophylactic, diagnostic and therapeutic 
procedures identified as beneficial in the study or access to other appropriate care. Post-trial 
access arrangements or other care must be described in the study protocol so the ethical review 
committee may consider such arrangements during its review.  
 
 

Chansu Vascular Technologies, LLC 
The CVT-ISR Trial 
TP1125 Revision A 
 
CONFIDENTIAL 
Page 64 of 74 
 
APPENDIX E: INSTRUCTIONS FOR USE: LBL1121 
(Note : the document included or referenced in this appendix is a controlled document ; the version in this 
appendix may not be the most current version. Contact the Sponsor or site coordinator for confirmation of 
the most current revision.) 
 
 

 
LBL1121 Rev B, DCO#0072 
Page 1 of 31 
 
 
 
 
CVT EVEROLIMUS-COATED PERCUTANEOUS TRANSLUMINAL 
CORONARY ANGIOPLASTY (PTCA) CATHETER 
 
 
INSTRUCTIONS FOR USE 
 
 
ALL INSTRUCTIONS, PRECAUTIONS AND WARNINGS SHOULD BE 
CAREFULLY READ AND UNDERSTOOD BEFORE USE.  FAILURE TO 
DO SO MAY RESULT IN COMPLICATIONS. 
 
 
EXCLUSIVELY FOR CLINICAL INVESTIGATIONS 
 
 

CHANSU VASCULAR TECHNOLOGIES 
EVEROLIMUS-COATED PTCA CATHETER 
LBL1121 Rev B, DCO#0072    
                                                       Page 2 of 31 
CONTENTS 
CONTENTS.............................................................................................................. 2 
1. 
DEVICE NAME ............................................................................................ 4 
2. 
INTRODUCTION.......................................................................................... 4 
3. 
DEVICE DESCRIPTION .............................................................................. 4 
3.1. 
Description of the Device ............................................................................... 4 
3.2. 
CVT Everolimus Coating Description ........................................................... 5 
4. 
INDICATIONS FOR USE ............................................................................. 5 
5. 
CONTRAINDICATIONS .............................................................................. 5 
5.1. 
Contraindications ........................................................................................... 5 
5.2. 
Restrictions ..................................................................................................... 5 
6. 
WARNINGS .................................................................................................. 5 
7. 
PRECAUTIONS ............................................................................................ 6 
8. 
DRUG INFORMATION................................................................................ 8 
8.1.     Mechanism of Action ..................................................................................... 8 
8.2.     Drug Interactions ........................................................................................... 8 
8.3.     Carcinogenicity, Genotoxicity and Reproductive Toxicology ....................... 8 
9. 
POTENTIAL ADVERSE EVENTS .............................................................. 8 
9.1. 
Adverse Events............................................................................................... 8 
10. 
HOW SUPPLIED......................................................................................... 10 
10.1. Sterile, For Single Use only ......................................................................... 10 
10.2. Storage ......................................................................................................... 10 
11. 
INSTRUCTIONS FOR USE ........................................................................ 10 
11.1. Materials Required ....................................................................................... 10 
11.2. Inspection Procedures .................................................................................. 10 
11.3. Preparation of Catheter for Use .................................................................... 10 
11.4. Catheter Introduction and Dilatation ............................................................ 11 
11.5. Post-Treatment Dilatation or Stenting .......................................................... 13 
11.6. Instructions on Related, Additional Devices ................................................ 13 

CHANSU VASCULAR TECHNOLOGIES 
EVEROLIMUS-COATED PTCA CATHETER 
LBL1121 Rev B, DCO#0072    
                                                       Page 3 of 31 
12. 
INSTRUCTIONS ON HOW TO SAFELY DISPOSE OF THE CVT 
EVEROLIMUS-COATED PTCA CATHETER .......................................... 13 
13. 
WARRANTY ............................................................................................... 13 
14. 
SYMBOLS ................................................................................................... 14 
 
 
 

CHANSU VASCULAR TECHNOLOGIES
EVEROLIMUS-COATED PTCA CATHETER
LBL1121 Rev B, DCO#0072   
                                                       Page 4 of 31
1.
DEVICE NAME
Everolimus-coated Percutaneous Transluminal Coronary Angioplasty (PTCA) 
Catheter manufactured by Chansu Vascular Technologies (CVT).
2.
INTRODUCTION
The CVT Everolimus-coated PTCA Catheter consists of an Rx PTCA catheter 
with an Everolimus-coated balloon.
Caution:  Only physicians experienced in percutaneous coronary interventional 
procedures should use the CVT Everolimus-coated PTCA Balloon Catheter.  
Before using the catheter, the operators should be familiar with the contents of 
the instructions for use.  Special attention should be made to the indications, 
contraindications, restrictions, warnings and precaution statements as noted in 
this manual.
3.
DEVICE DESCRIPTION
3.1.
Description of the Device
  
Figure 1. CVT Everolimus-coated PTCA Catheter
 
Basic Catheter Specifications

CHANSU VASCULAR TECHNOLOGIES
EVEROLIMUS-COATED PTCA CATHETER
LBL1121 Rev B, DCO#0072   
                                                       Page 5 of 31
x
           
x
  
x
 
x
x
The investigational device will be provided sterile, with the sterile device 
packaged in a foil pouch and contained within a single unit box.  
3.2.
CVT Everolimus Coating Description
4.
INDICATIONS FOR USE
The CVT Everolimus-coated PTCA Catheter is intended to be used for 
improving luminal diameter and myocardial perfusion in patients presenting in-
stent stenotic lesions ≤24 mm in length in native coronary arteries with reference 
vessel diameters of 2-3.5mm.
5.
CONTRAINDICATIONS
5.1.
Contraindications
Refer to the Clinical Investigational Plan for study exclusion criteria.
5.2.
Restrictions
The CVT Everolimus-coated PTCA Catheter is an investigational device and 
may only be used if the subject has provided study informed consent.  Use is 
restricted to investigator physicians who are experienced in the clinical and 
technical aspects of angioplasty.
6.
WARNINGS
x
The CVT Everolimus-coated PTCA Catheter is supplied STERILE for 
single use only.  Do not use if the sterile barrier (inner Tyvek pouch) is 
compromised.
x
Do not reprocess or re-sterilize the CVT Everolimus-coated PTCA 
Catheter.  Re-processing and/or re-sterilizing could increase the risk of 
patient infection and the risk of compromised device performance.
x
This device is not recommended for stent delivery.

CHANSU VASCULAR TECHNOLOGIES 
EVEROLIMUS-COATED PTCA CATHETER 
LBL1121 Rev B, DCO#0072    
                                                       Page 6 of 31 
x 
Do not use after the labeled “Use by” date. 
x 
Do not exceed the Rated Burst Pressure (RBP) for the device. Refer to 
product label for device specific inflation information. At least 99.9% 
of the balloons (with a 95% confidence) will not burst at or below the 
RBP. Balloon rupture may occur if the RBP is exceeded. 
x 
Use of a pressure-monitoring device is recommended to prevent over 
pressurization.  
x 
Use only the recommended balloon inflation medium. Never use air or 
any gaseous medium to inflate the balloon. 
x 
Since the use of this device carries the associated risk of subacute 
thrombosis, vascular complications and/or bleeding events, judicious 
selection of subjects is necessary. 
x 
After use, dispose of the catheters and accessories according to safety 
requirements related to products contaminated by blood. 
x 
Do not expose the catheter to ionizing radiation, ultraviolet light or 
organic solvents, e.g. alcohol. 
x 
To reduce the potential for vessel damage, the inflated diameter of the 
balloon should approximate the diameter of the vessel just proximal 
and distal to the stenosis. 
x 
When the CVT Everolimus-coated PTCA Catheter is exposed to the 
vascular system, it should be manipulated under high-quality 
fluoroscopic observation. 
x 
If resistance is encountered at any time during the insertion procedure, 
determine the cause before proceeding. 
x 
Do not attempt to straighten the CVT Everolimus-coated PTCA 
Catheter if the shaft has become bent or kinked as this may result in the 
shaft breaking. Instead, retract the device and prepare a new device for 
use. 
7. 
PRECAUTIONS 
x 
A thorough understanding of the principles, clinical applications and 
risks associated with Percutaneous Transluminal Coronary Angioplasty 
(PTCA) is necessary before using this product. 
x 
Any use of the CVT Everolimus-Coated PTCA Catheter for procedures 
other than those indicated in these instructions is not recommended. 

CHANSU VASCULAR TECHNOLOGIES 
EVEROLIMUS-COATED PTCA CATHETER 
LBL1121 Rev B, DCO#0072    
                                                       Page 7 of 31 
x 
This CVT Everolimus-Coated PTCA Catheter is not recommended for 
use in lesions that may require inflation higher than those 
recommended for the device. 
x 
Do not use if the package is open or damaged. 
x 
Prior to angioplasty, the CVT Everolimus-Coated PTCA Catheter 
should be examined to verify functionality and ensure that its size and 
shape are suitable for the specific procedure for which it is to be used.  
x 
Proper functioning of the CVT Everolimus-Coated PTCA Catheter is 
dependent on its integrity. Care should be used when handling the 
catheter.  Damage may result from kinking, stretching or manipulation 
of the catheter. 
x 
Before removing CVT Everolimus-Coated PTCA Catheter from the 
sheath/guiding catheter it is very important that the balloon is 
completely deflated. 
x 
Precautions to prevent or reduce clotting should be taken when any 
catheter is used. Flush or rinse all products entering the vascular system 
with sterile isotonic saline or a similar solution via the guidewire access 
port prior to use. Consider the use of systemic heparinization. 
x 
Never attempt to move the guidewire when the balloon is inflated. 
x 
Never advance the catheter without the guidewire extending from the 
tip. 
x 
If resistance is felt upon the removal of the device, the CVT 
Everolimus-coated PTCA Catheter, guidewire and sheath/guiding 
catheter should be removed together as a unit, particularly if balloon 
rupture or leakage is suspected. This may be accomplished by firmly 
grasping the CVT Everolimus-coated PTCA Catheter, guidewire and 
sheath/guiding catheter as a unit and withdrawing all together from the 
vasculature, using a twisting motion combined with retraction. 
x 
During the procedure, appropriate anti-coagulant therapy must be 
provided to the subject as needed. Anti-coagulant therapy should be 
continued for a period of time to be determined by the physician after 
the procedure. 

CHANSU VASCULAR TECHNOLOGIES
EVEROLIMUS-COATED PTCA CATHETER
LBL1121 Rev B, DCO#0072   
                                                       Page 8 of 31
8.
DRUG INFORMATION
8.1.
Mechanism of Action
 
8.2.
Drug Interactions
Formal drug interaction studies have not been conducted for the CVT 
Everolimus-coated PTCA Catheter.  The respective instructions for use for all 
drugs used in conjunction with the CVT Everolimus-coated PTCA Catheter 
should be consulted for interactions with Everolimus.  Consideration should be 
given to the potential for systemic and local drug interactions in the vessel wall 
in a patient who is taking a drug with known interactions to Everolimus or when 
deciding to initiate drug therapy in a patient who has been treated with the CVT 
Everolimus-coated PTCA Catheter. In the absence of formal drug interaction 
studies, caution should be exercised when administering Everolimus.
8.3.
Carcinogenicity, Genotoxicity and Reproductive Toxicology
No long-term studies have been performed to evaluate the carcinogenic potential 
of the CVT Everolimus-coated PTCA Catheter.  Do not use the CVT 
Everolimus-coated PTCA Catheter in women who are pregnant or intending to 
become pregnant.  
9.
POTENTIAL ADVERSE EVENTS 
9.1.
Adverse Events
Potential complications which may be associated with a coronary balloon 
dilation procedure include, but may not be limited to, the following: 

CHANSU VASCULAR TECHNOLOGIES 
EVEROLIMUS-COATED PTCA CATHETER 
LBL1121 Rev B, DCO#0072    
                                                       Page 9 of 31 
Acute myocardial Infarction (Cardiac) • Aneurysm • Arrhythmias, including 
ventricular fibrillation (bradycardia & tachycardia) • Arterial dissection • 
Arteriovenous fistula • Bleeding • Coronary artery spasm • Coronary artery 
thrombosis • Death (cardiovascular or non-cardiovascular related) • Discomfort 
during procedure • Drug reactions or allergic reactions to contrast medium  • 
Distal embolism (air, thrombus, plaque)/Device embolism • Endocarditis • Fever 
• Groin bruising/discomfort • Hematoma • Hemorrhage • 
Hypotension/hypertension • Injury at blood vessel access site requiring surgical 
or medical treatment • Ischemia • Pseudoaneurysm • Renal failure • Restenosis 
of the dilated vessel • Sepsis, infection • Stroke or cerebrovascular event • Total 
occlusion of the coronary artery or bypass graft • Unstable angina • Vessel 
dissection, perforation, rupture or injury • Thrombosis • Vomiting/Nausea 
The oral formulation of everolimus has been evaluated in clinical trials and is 
approved worldwide for the prophylaxis of organ rejection in adult kidney 
transplant recipients at low-moderate immunologic risk and for the treatment of 
patients with advanced renal cell carcinoma. Oral dose of everolimus depending 
on the indication ranges between 1.5 and 20 mg/day. The following list includes 
the known risks of everolimus at these oral doses. 
The following is a list of theoretical adverse events that may result from the 
addition of everolimus to a PTCA catheter: 
Abdominal pain • Anemia • Angioedema • Anorexia • Asthenia • Constipation • 
Cough • Delayed wound healing/fluid accumulation • Diarrhea • Dyslipidemia 
(including hyperlipidemia and hypercholesterolemia) • Dysgeusia • Dyspepsia • 
Dyspnea • Dysuria • Dry Skin • Edema (peripheral) • Epistaxis • Fatigue • 
Headache • Hematuria • Hyperglycemia • Hyperkalemia • Hyperlipidemia • 
Hypertension • Hypokalemia • Hypomagnesemia • Hypophosphatemia • 
Increased serum creatinine • Infections and serious infections: bacterial, viral, 
fungal, and protozoal infections • Insomnia • Interaction with strong inhibitors 
and inducers of CYP3A4 or PgP • Leukopenia • Lymphoma and other 
malignancies (including skin cancer) • Male infertility • Mucosal inflammation • 
Nausea • Neutropenia • Non-infectious pneumonitis • Pain: extremity, incision 
site and procedural, back • Proteinuria • Pruritus • Pyrexia • Rash • Stomatitis • 
Thrombocytopenia • Thrombotic microangiopathy • Thrombotic 
thrombocytopenic purpura •Tremor • Upper respiratory tract infection • Urinary 
tract infection • Vomiting 

CHANSU VASCULAR TECHNOLOGIES 
EVEROLIMUS-COATED PTCA CATHETER 
LBL1121 Rev B, DCO#0072                                                           Page 10 of 31 
10. 
HOW SUPPLIED 
10.1. 
 Sterile, For Single Use only 
The CVT Everolimus-coated PTCA Catheter is supplied sterile (ethylene oxide 
sterilization).  The device is for single patient use only.  Do not re-sterilize, re-
use or re-process the device.  Do not use if the Tyvek sterile barrier is damaged. 
10.2. 
Storage 
The CVT Everolimus-coated PTCA Catheter should be stored at ambient 
temperature in a dry location in its original packaging.   The device should be 
used prior to the labeled “Use by” date on the device packaging. 
11. 
INSTRUCTIONS FOR USE 
11.1. 
Materials Required 
x 
20 cc syringe 
x 
Heparinized saline solution 
x 
Three-way stopcock 
x 
Contrast Media-the standard inflation medium is a 1:1 mixture of 
contrast medium and normal saline.  Do not use contrast media that is 
contraindicated for intravascular use. 
x 
Appropriately sized exchange guidewire (refer to product labeling) 
x 
Appropriately sized hemostatic introducer sheath (refer to product 
labeling) 
x 
Inflation device with manometer 
11.2. 
Inspection Procedures 
Inspect the CVT Everolimus-coated PTCA Catheter and packaging.  Do not use 
if packaging or product damage is evident.  This product may be a potential 
biohazard; handle and dispose of it in accordance with accepted medical practice 
and applicable local, state and federal laws and regulations. 
Inspect the CVT Everolimus-coated PTCA Catheter “Use By” date.  Use before 
the labeled “Use By” date. 
11.3. 
Preparation of Catheter for Use 
1. Carefully remove the CVT Everolimus-coated PTCA Catheter from the 
package. 

CHANSU VASCULAR TECHNOLOGIES 
EVEROLIMUS-COATED PTCA CATHETER 
LBL1121 Rev B, DCO#0072                                                           Page 11 of 31 
2. Slide the protective sheath off the balloon.  Remove any mandrel that 
might be present in the guidewire lumen. 
3. Flush the guidewire lumen with heparinized saline solution.  
4. Prepare an inflation device with the recommended contrast medium 
(50% contrast and 50% saline as per normal procedure). 
5. To evacuate air from balloon segment: 
a. 
Fill a 20 cc syringe or inflation device with approximately 4 cc of 
the recommended contrast medium. 
b. After attaching syringe or the inflation device to the balloon 
inflation lumen, orient the CVT Everolimus-coated PTCA Catheter 
with the distal tip and the balloon pointing in a downward vertical 
position.  
c. 
Apply negative pressure and aspirate for 15 seconds. Slowly 
release pressure to neutral, allowing contrast to fill the shaft of the 
catheter. 
d. Disconnect the syringe or inflation device from the inflation port of 
the CVT Everolimus-coated PTCA Catheter. 
e. 
Remove all air from the syringe or inflation device barrel. 
Reconnect the syringe or inflation device to the inflation port of 
the CVT Everolimus-coated PTCA Catheter. Maintain negative 
pressure until air no longer returns to the device.  
f. 
Slowly release the device pressure to neutral. 
6. Disconnect the 20cc syringe (if used) and connect the inflation device 
to the inflation port of the catheter without introducing air into the 
system. Note: All air must be removed from the balloon and displaced 
with contrast prior to inserting in the body otherwise, complications 
may occur. 
7. Replace the syringe with an inflation device with manometer, taking 
care not to introduce air into the catheter. 
11.4. 
Catheter Introduction and Dilatation 
1. 
The CVT Everolimus-coated PTCA Catheter can be introduced 
percutaneously through an appropriately sized introducer sheath.  Do 
not attempt to use a smaller sized introducer sheath than indicated 
on the product label.   
2. 
Apply negative pressure to the balloon.   

CHANSU VASCULAR TECHNOLOGIES 
EVEROLIMUS-COATED PTCA CATHETER 
LBL1121 Rev B, DCO#0072                                                           Page 12 of 31 
3. 
Place the prepared CVT Everolimus-coated PTCA Catheter over a 
pre-positioned guidewire, which has been placed through the lesion, 
and introduce the catheter percutaneously.  Negative pressure should 
be maintained during advancement over the guidewire. Advance the 
catheter tip to the treatment location. A suitable length guidewire 
should be used at all times to maintain control and position of the 
guidewire.   
4. 
Use fluoroscopic guidance for all further catheter manipulations 
during the procedure.  If resistance is encountered at any time 
during the insertion procedure, do not force passage.  Resistance 
may cause damage to the device or lumen.  If resistance is 
encountered carefully withdraw the CVT Everolimus-coated PTCA 
Catheter.  It may be necessary to remove the device, guidewire and 
guiding catheter/sheath as one unit. 
5. 
Position the CVT Everolimus-coated PTCA Catheter at the treatment 
location.  The radiopaque marker bands indicate the working length of 
the balloon.  The position of the balloon may only be modified with 
the guidewire in place. 
6. 
Inflate the balloon to dilate the desired target diameter according to 
the compliance chart printed on the device packaging.   Inflation 
should be maintained for sixty (60) seconds.   Inflation should not be 
in excess of the rated burst pressure. 
7. 
Deflate the balloon and apply negative pressure. 
8. 
With the guidewire in place and with negative pressure in the balloon, 
withdraw the CVT Everolimus-coated PTCA Catheter.  Do not retract 
the device unless the balloon is free and fully deflated. 
9. 
If more than one CVT Everolimus-coated PTCA Catheter is required 
to treat a single lesion, the balloon portion of each device must 
overlap by at least one (1) centimeter.  A new, unused balloon must be 
used for each deployment.  No more than 2 devices can be used to 
treat a single lesion. 
10. Results should be verified by angiography.   
11. The CVT Everolimus-coated PTCA Catheter is a single use device.  
Do not re-use or re-sterilize.  
12. If the CVT Everolimus-coated PTCA Catheter has entered the 
vasculature and cannot be deployed, the device CANNOT be re-
inserted for deployment.  

CHANSU VASCULAR TECHNOLOGIES 
EVEROLIMUS-COATED PTCA CATHETER 
LBL1121 Rev B, DCO#0072                                                           Page 13 of 31 
11.5. 
 Post-Treatment Dilatation or Stenting 
1. If post-treatment dilatation is required, a standard PTCA catheter 
should be used. 
2. If provisional (bail out) stenting is required a bare metal stent 
indicated for treatment of coronary arteries should be used.  
11.6. 
Instructions on Related, Additional Devices 
If required, a bare metal stent indicated for use in the native coronary arteries 
can be used after treatment with the CVT Everolimus-coated PTCA Catheter. 
12. 
INSTRUCTIONS ON HOW TO SAFELY DISPOSE OF THE CVT 
EVEROLIMUS-COATED PTCA CATHETER 
After use, the CVT Everolimus-coated PTCA Catheter may be considered a 
potential biohazard.  Handle and dispose of in accordance with accepted medical 
practice and applicable local, state and federal laws and regulations. 
13. 
WARRANTY 
Although the CVT Everolimus-coated PTCA Catheter has been manufactured 
under carefully controlled conditions, CVT has no control over the conditions 
under which this product is used.  CVT therefore disclaims all warranties, both 
express and implied, with respect to the product including, but not limited to, 
any implied warranty of merchantability or fitness for a particular purpose.  
CVT shall not be liable to any person or entity for any medical expenses, or any 
direct, incidental or consequential damages caused by any use, defect, failure or 
malfunction of the product, whether a claim for such damages is based upon 
warranty, contract, tort or otherwise.  No person has any authority to bind CVT 
to any representation or warranty with respect to the  product. The exclusions 
and limitations set out above are not intended to, and should not be construed so 
as to, contravene mandatory provisions of applicable law.  If any part or term of 
this Disclaimer of Warranty is held to be illegal, unenforceable or in conflict 
with applicable law by a court competent jurisdiction, the validity of the 
remaining portions of this Disclaimer of Warranty shall not be affected, and all 
rights and obligations shall be construed and enforced as if this Disclaimer of 
Warranty did not contain the particular part or term held to be invalid.   
 
 

CHANSU VASCULAR TECHNOLOGIES
EVEROLIMUS-COATED PTCA CATHETER
LBL1121 Rev B, DCO#0072                                                          Page 14 of 31
14.
SYMBOLS
Symbol
Meaning
Manufacturer
Available by Prescription only
Authorized European Community 
Representative
Do Not Use if Damaged
NP
Nominal Pressure
RBP
Rated Burst Pressure
Balloon Diameter
Balloon Length
Guide Wire
Content
Quantity of Contents
Catalog Number
Manufacturing Date
Use By (Expiry Date)
Lot Number
For Single Use only
Protect from Sunlight
Sterile by Ethylene Oxide Process
Caution, Consult Accompanying 
Documents
Keep Dry
Single Sterile Barrier System with 
Protective Packaging Outside
Do Not Resterilize

CHANSU VASCULAR TECHNOLOGIES
EVEROLIMUS-COATED PTCA CATHETER
LBL1121 Rev B, DCO#0072                                                            Page 15 of 31
Chansu Vascular Technologies, LLC

Chansu Vascular Technologies, LLC 
The CVT-ISR Trial 
TP1125 Revision A 
 
CONFIDENTIAL 
Page 65 of 74 
 
APPENDIX F: SCHEDULE OF EVENTS 
(1 page) 
 
 

Chansu Vascular Technologies, LLC 
The CVT-ISR Trial 
TP1125 Revision A 
 
CONFIDENTIAL 
Page 66 of 74 
 
PROCEDURE/TEST 
Prior to 
Procedure 
Pre-Procedure 
Procedure 
Pre-Discharge 
30 days 
(± 7 days) 
180 days 
(± 30 days) 
1 year 
(± 30 days) 
2 years 
(± 28 days) 
3 years 
(± 30 days) 
Patient Medical History 
X 
 
 
 
 
 
 
 
 
Review 
Inclusion/Exclusion 
Criteria5 
X 
 
 
 
 
 
 
 
 
Patient Informed Consent 
X 
 
 
 
 
 
 
 
 
Chronic Concomitant 
Medications/History 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Creatinine 
X 
 
 
 
 
 
 
 
 
CBC, Platelet Count 
X 
 
 
X 
 
 
 
 
 
Coagulation Tests 
X 
 
 
X 
 
 
 
 
 
Pregnancy Test (if 
applicable) 
X 
 
 
 
 
 
 
 
 
CK-Mb 
 
X 
 
X 
 
 
 
 
 
Cardiac Troponin (cTn) 
 
X 
 
X 
 
 
 
 
 
12 Lead ECG3 
 
X 
 
X 
 
X 
X 
 
 
Coronary angiogram 
 
 
X1 
 
 
X2 
 
 
 
IVUS 
 
 
X6 
 
 
X6 
 
 
 
OCT 
 
 
X7 
 
 
X7 
 
 
 
Physical Examination 
X 
 
 
 
X8 
X 
X 
 
 
Per-protocol medications 
 
X 
X 
X 
X 
X 
X 
X 
X 
Physical status q’naire  
 
 
 
 
X8 
 
 
X 
X 
Adverse events4 
 
 
X 
X 
X 
X 
X 
X 
X 
1  Prior to and immediately post in-stent treatment with CVT Everolimus-coated PTCA Catheter. 
2  
In a subset of 25 patients at both index procedure and 180 day follow up  
3  
A 12 lead ECG will be performed within 24 hours post-procedure. Relevant copies of ECGs will be collected for death or 
any (suspected) myocardial infarction or (suspected) stent thrombosis that occurs after the index procedure for adjudication 
purposes by a Clinical Events Committee (CEC). This includes copies of the baseline ECG (screening and discharge) and 
event ECG (most abnormal ECG and last ECG recorded) if available. 
4  
AE collection will start when CVT Everolimus-coated PTCA Catheter has entered the vasculature. 
5  
A log of patients presenting to sites with in-stent restenosis be maintained and provide reasons for not including subjects in 
the study. 
6. 
In a subset of 15 subjects at both index procedure and 180 day follow up 
7. In a subset of 10 subjects at both index procedure and 180 day follow up 
8.   Depending on if the 30 day follow up is an office visit (exam) or phone call (questionnaire) 
 
 

Chansu Vascular Technologies, LLC 
The CVT-ISR Trial 
TP1125 Revision A 
 
CONFIDENTIAL 
Page 67 of 74 
 
APPENDIX G: RESEARCH AGEEMENT TEMPLATE: FRM1122 
(Note : the document included or referenced in this appendix is a controlled document ; the version in this 
appendix may not be the most current version. Contact the Sponsor or site coordinator for confirmation of 
the most current revision.) 
 
 

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 1 of 28
CVT-ISR FIH CLINICAL TRIAL
ETUDE CVT-ISR FIH
Sponsor: Chansu Vascular Technologies LLC (CVT)
Contact Person:
Research Institution: 
Research Institution/Contact Person:
THIS CLINICAL STUDY AGREEMENT
 
Chansu Vascular Technologies LLC (CVT), 
 
("Sponsor"),
and
INSTITUTION XXXXXX
Promoteur : Chansu Vascular Technologies LLC 
Etablissement : 
Institut de recherche/Contact:
LE PRESENT CONTRAT RELATIF A UNE 
ETUDE CLINIQUE
Chansu Vascular Technologies LLC (CVT),
(le 
« Promoteur »),
et
INSTITUTION XXXXXX
CLINICAL STUDY RESEARCH INSTITUTION AGREEMENT  
 

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 2 of 28
1. SCOPE Of WORK
 
 
1.2
Research Institution 
 
1.3
Study Device
1. ETENDUE DE LA CHARGE DE TRAVAIL
1.2 Institut de recherche
1.3 Dispositif expérimental.
.

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 3 of 28
1.3.2 Billing:
1.4
Adverse Events
.
1.5
Deviations.
1.6
Public Registry.
2.
COSTS: PAYMENT
2.1
Consideration.
1.3.2
Facturation.
1.4 Evènements indésirables.
1.5 Déviations.
1.6 Registre public.
2.
COUTS: PAIEMENTS
2.1 Rémunération.

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 4 of 28
2.2
Fair Market Value.
2.3
Disclosure of Payments to Health Care
Professionals.
2.2 Juste valeur marchande.
 
2.3 Divulgation de paiement aux professionnels
de santé.

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 5 of 28
3.
REPORTS: ACCESS
3.1
Documentation Provided by Investigator
3.2
Subject Privacy
3.
RAPPORTS: ACCES
3.1 Documentation fournie par l’investigateur.
3.2 Protection de la vie privée des Patients

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 6 of 28
3.3
Access.
 
s en matière de protection de la vie
privée.
3.3 Accès.

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 7 of 28
3.4
Inspections.
 
    
3.5
Records and Reports. Research.
3.4 Inspections. 
e
3.5 Registres et rapports. 

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 8 of 28
.
4.
SPONSOR MATERIALS
 
4.
MATERIELS DU PROMOTEUR

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 9 of 28
5.
CONFIDENTIAL INFORMATION
    
 
6.
REPORTS, RESULTS AND INVENTIONS
6.1
Reports and Results.
   
 
5.
INFORMATIONS CONFIDENTIELLES
   

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 10 of 28
6.2
Inventions.
7.
INDEMNITY AND INSURANCE
7.1
By Sponsor.
6.
RAPPORTS, RESULTATS ET
INVENTIONS
6.1 Rapports et résultats.
6.2 Inventions.
7.
INDEMNISATION ET ASSURANCE
7.1 Par le Promoteur.

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 11 of 28
7.2
By Research Institution.
7.3
Conditions of Indemnity
7.4
Insurance
7.4.1 Sponsor.
7.2 Par l’institut de recherche.
7.3 Conditions d'indemnisation.

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 12 of 28
7.4.2 Research Institution.
7.4.3
8.
TERM AND TERMINATION
8.1
Term.
8.2
Early Termination.
8.3
Duties upon Termination.
     
7.4 Assurance.
7.4.1Promoteur.
7.4.2 L’institut de recherche. 
7.4.3 Par ailleurs,
8.
DUREE DE VALIDITE ET RESILIATION
8.1 Durée de validité.
8.2 Résiliation anticipée.

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 13 of 28
9.
COVENANTS AND WARRANTIES
9.1
Absence of Restrictions.
9.2
Conduct of Study.
9.3
Prior and Future Conduct.
8.3 Obligations en cas de résiliation.
9.
ENGAGEMENTS ET GARANTIES
9.1 Absence de restrictions.
   
 
9.2 Déroulement de l’Etude. 
9.3 Conduite antérieure et ultérieure.  
 

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 14 of 28
9.4
Compliance with Applicable Laws.
9.4 Conformité au Droit applicable.
 

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 15 of 28
   
 
10.
MISCELLANEOUS
10.1 Entirety.
11.2 Governing Law.
 

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 16 of 28
10.3 Severability.
.
10.4 Assignment.
10.5 Notices.
If to Research Institution:
XXXXXX
If to Sponsor:
Chansu Vascular Technologies LLC.
10.6 Independent Contractors. 
10. DISPOSTIONS DIVERSES
10.1 Intégralité du Contrat.
10.2 Droit applicable.
10.3 Autonomie des dispositions.
10.4 Cession.
10.5 Avis.

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 17 of 28
10.7 Modification.
10.8 Waiver.
   
 
10.9 Counterparts.
10.10 Headings.
10.11 Interpretation.
    
 
10.12 Publicity.
Pour l’institut de recherche : 
XXXX
Pour le Promoteur :
Chansu Vascular Technologies LLC.
10.6 Entrepreneurs indépendants.
10.7 Modification.
10.8 Renonciation.
10.9 Exemplaires.

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 18 of 28
10.10 Titres.
10.11 Interprétation.
10.12 Publicité.
 
The parties have caused this Agreement to be executed 
as of the Effective Date.
Les parties ont fait signer le présent Contrat à la Date 
d'entrée en vigueur.

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 19 of 28
Sponsor/Promoteur
Chansu Vascular Technologies LLC
By / Par : _________________________________
Date: ___________________
-----------------------------------------------------------------------------------------------------------------------
Research Institution /Coordinateur de la recherche
By / Par : _________________________________
Name title 
Date: ___________________

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 20 of 28
EXHIBIT A /ANNEXE A
EXHIBIT A
XXXXXX A
STUDY BUDGET – FEE SCHEDULE
Sponsor:  Chansu Vascular Technologies LLC
Institution: 
Investigator:  
Promoteur:  
Institution: 
Investigator: 
1.
Scope of Work 
 
 
  
(Remainder of page intentionally left blank.)
1.
XXXXXX
 
 

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 21 of 28
2.
Payee Information
All payments associated with the Study shall be made 
by Sponsor. Complete table
2.
XXX
Payee/Company Information
Company Name: 
Address: 
City, State and Zip: 
Contact Name: 
Telephone Number: 
Email: 
Tax ID Number (if applicable): 
COMPLETE THIS SECTION IF ELECTING TO 
RECEIVE ELECTRONIC PAYMENTS
Bank Name: 
Bank Address:
SWIFT Code: 
Bank Code: 
Account Number: 
IBAN: 
Account Name: 
xxxxxxxx / xxxxxxxxxx
xxxxxxxx: 
xxxxxx: 
xxxxxxx: 
xxxxxxx: 
tel.: 
e-mail: 
xxxx (xxxxxxxx): 
XXXXX
XXXXXX
xxxxx: 
xxxxx:
SWIFT: 
xxxx: 
xxxxx: 
IBAN xxxx: 
xxxxxxxx: 
3.
Study Device and Equipment
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.
xxxxxxxxx
 
 

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 22 of 28
4.
Institution Fees
Ethics Committee (EC) 
Fees
Amount
1.
2.
3.
Study Start-up Fee
Amount
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.
xxxxxx
xxxxx (EC)
xxxxxx
1.
xxxx
2.
xxxxx
3.
xxxxx
poplatek za zahájení studie
částka
5.
Baseline Administration Support Research 
Services
 
 
 
 
 
 
  
5.
xxxxxxx

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 23 of 28
 
 
 
 
 
 
 
 
Milestone 
Schedule.
 
 
 
 
 
 
 
 
 
 
 
 
  
 
xxxxxxxxxxxxx.

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 24 of 28
Milestone
Amount
 
 
 
 
 
 
 
 
 
 
TOTAL
xxxxx
xxxxx
TOTAL

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 25 of 28
6.
Expedited Data Collection
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
6.
xxxxxxxxx
 
 

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 26 of 28
7.
Medical Procedures or Services  
 
a) Preauthorization/Precertification for Standard 
of Care Medical Procedures or Services.  
 
 
 
 
 
 
 
  
b) Study 
Devices. 
 
 
 
 
  
.
8.
Qualifications for Payments.
 
   
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
7.
xxxxxxxxx
a) xxxxxxxxxxxxxx 
b) xxxxxxxxxxxxxx. 
8.
xxxxxx.

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 27 of 28
9.
Payment.  
  
 
Please send all the invoices with specified 
wire transfer instructions to:
Chansu Vascular Technologies LLC; 
9.
xxxxxx.

Chansu Vascular Technologies
CVT-ISR FIH Trial
Clinical Study Research Institution Agreement
FRM1122 Rev. A, DCO#0034. Effective Date: 01-Jun-2021
Page 28 of 28
Please send all the invoices with specified wire transfer instructions to:
Chansu Vascular Technologies LLC;
THIS EXHIBIT A SETS FORTH ALL PAYMENTS TO BE MADE BY SPONSOR TO RESEARCH 
INSTITUTION AND INVESTIGATORS IN CONNECTION WITH THIS AGREEMENT AND, IF 
THE PARTIES HAVE ENTERED INTO A CLINCAL TRIAL AGREEMENT FOR THE CVT-ISR-FIH
TRIAL, IN CONNECTION WITH EXPEDITED DATA COLLECTION PURSUANT TO SUCH 
OTHER AGREEMENT, IF APPLICABLE.  NO OTHER ADDITIONAL PAYMENT REQUESTS 
WILL BE CONSIDERED WITHOUT THE PRIOR WRITTEN CONSENT OF SPONSOR.
AGREED TO BY:
Name Printed: __________________________
Signature
__________________________
Title:
__________________________
Date:
__________________________
SPONSOR
Name Printed: __________________________
Signature
__________________________
Title:
__________________________
Date:
__________________________

Chansu Vascular Technologies, LLC 
The CVT-ISR Trial 
TP1125 Revision A 
 
CONFIDENTIAL 
Page 68 of 74 
 
APPENDIX H: INVESTIGATOR’S RESONSIBILITIES 
(1 page) 
 
 

Chansu Vascular Technologies, LLC 
The CVT-ISR Trial 
TP1125 Revision A 
 
CONFIDENTIAL 
Page 69 of 74 
 
Investigators Responsibilities 
1. 
Have and maintain the resources necessary to conduct the clinical investigation properly. 
2. 
Ensure that conducting the clinical investigation is not nor will not cause a conflict of interest. 
3. 
Obtain from the sponsor information which the clinical investigator judges essential about the device 
and be familiar with this information. 
4. 
Understanding of the Clinical Investigational Plan (CIP)/Protocol prior to signing it. 
5. 
Compliance with the CIP and any amendments. 
6. 
Support the monitor in their activities to verify compliance with the CIP, to perform source data 
verification, and to correct case report forms where inconsistencies or missing data is identified. 
7. 
Discuss with the sponsor and monitor any question of modification of the clinical investigation plan 
and obtain written approval of the sponsor. 
8. 
Ensure the clinical investigation plan is followed by all persons responsible for the conduct of the 
clinical investigation at the institution.  Any deviation must be documented and reported to the 
sponsor. 
9. 
Make the necessary arrangements to ensure the proper conduct and completion of the clinical 
investigation. 
10. Make the necessary arrangements for emergency treatment, as needed, to protect the health and 
welfare of the subject. 
11. Ensure that appropriate ethics committee approval has been received prior to the start of the clinical 
investigation at the center. 
12. Provide the results from the ethics committee to the sponsor. 
13. Inform the ethics committee and request opinion and/or approval for any significant change in the 
clinical investigation plan that has been approved by the sponsor. 
14. Inform the ethics committee about any serious adverse device effect and/or serious adverse event. 
15. Inform the sponsor about all adverse events, serious adverse ecents and adverse device effects in a 
timely manner. 
16. Attempt to ensure an adequate recruitment of subjects. 
17. Ensure that the subject has adequate information to give informed consent. 
18. Ensure that informed consent is obtained and documented. 
19. Ensure that clinical records are clearly marked to indicate the subject is enrolled in a particular clinical 
investigation.  If appropriate, subjects enrolled in the clinical investigation must be provided with 
some means of showing their participation in the investigation, together with identification and 
compliance information for concurrent treatment measures.  Contact addresses/telephone numbers 
must be provided.  If appropriate, the subject’s personal physician should, with the subject’s 
agreement, be informed. 
20. Provide subjects with well-defined procedures for any emergency situation and safeguard the subject’s 
interest.  Under these circumstances, deviations from the clinical investigation plan will not require the 
prior approval of the sponsor or the ethics committee.  Such deviations must not be considered as a 
breach of agreement but shall be documented and reported to the sponsor. 
 
 

Chansu Vascular Technologies, LLC 
The CVT-ISR Trial 
TP1125 Revision A 
 
CONFIDENTIAL 
Page 70 of 74 
 
APPENDIX I: ANGIOGRAPHIC CORE LAB GUIDELINES AND WORKSHEET 
(4 pages) 
 
 

 
    1            
 Version 1.0 
Confidential         
Sep-21-2021 
 
Technician’s Worksheet 
  CVT-ISR Study 
 Instructions for use: 
 
For each sequence, please document the lesion undergoing treatment using the following abbreviations: 
Lesion treated: Left Anterior Descending Artery(LAD), Diagonal Branch(Diag), Diag, Left Circumflex Artery(LCX), Obtuse 
Marginal Branch(OM), Right Coronary Artery(RCA), Posterior Descending Artery(PDA), Posterolateral Branches(PL). 
Please note whether catheter was a diagnostic (D) catheter or a guiding (G) catheter. 
The size of all devices used must recorded. 
Site ID _______________  
Patient ID    _______________            
Patient Initials _______________        
 Cath date:  ___  ___  _______      
MM     DD    YYYY
Sequences 
Lesion Treated 
Device Name with Size 
information 
Catheter 
French size 
IC 
NTG(Yes/No) 

 
Angiographic Core Laboratory 
 
 
 
 
         
      1    
 Version 1.0 
Confidential            
  Sep-21-2021 
 
 
CVT-ISR TRIAL 
INSTRUCTIONS TO THE SITE 
•

•
•
•
•
•
•
•

             
 
Angiographic Core Laboratory  
 
                           2                                                              Version 1.0 
Confidential                                                                                                                                 Sep-21-2021 
 
 
ANGIOGRAPHIC Do’s and Don’ts  
 
Do’s 
•
 
 
 

 
 
• 
 
 
 
•
 
 
Don't 
• 
 
 
• 
 
 
 
 
 
 
•
 
 
 
•
 
 
 
       IMAGE TRANSFER/SHIPPING REQUIREMENTS 
 
Please send the angiograms as instructed by sponsor. 
 
If instructed to send images along with TWS to ACL, please ship to: 
 
 
 
 
 
 
 
 
 
 
 

               
 
Angiographic Core Laboratory  
 
 
 
 
 
                           3                                                              Version 1.0 
Confidential                                                                                                                                 Sep-21-2021 
 
 
 
 
                                                                 Contact Sheet 
 
 
 
 
   
  
  
  
  
  
  
 
 
  
 
 
 
 
 
 
  
 
 
  
 
 
 
  
  
  
  
 
 
 
  
  
  
  
  
  
  
  
  
  
 
 
 

Chansu Vascular Technologies, LLC 
The CVT-ISR Trial 
TP1125 Revision A 
 
CONFIDENTIAL 
Page 71 of 74 
 
APPENDIX J: RISK ANALYSIS 
A full risk management file (RMF1018) is complete and available for the CVT Everolimus-coated PTCA 
Catheter. 
The summary of the risk analysis is presented in this appendix. 
The local application of anti-proliferative drugs (e.g., sirolimus, zotarolimus, everolimus, and paclitaxel) 
for prevention of restenosis in coronary arteries via a stent delivery system has shown that these therapies 
successfully inhibit or reduce restenosis. This has reduced the need for patients with coronary artery 
disease to undergo repeat percutaneous and surgical revascularizations. The success of drug-eluting stents 
in the coronary arteries triggered an increased interest in using drug-eluting or drug-coated therapies in 
other vasculatures. Percutaneous transluminal balloon angioplasty (PTA) for revascularization of the 
superficial femoral artery (SFA) has an initial technical success rate of more than 95%. However, 
restenosis occurs in 50% to 60% of the treated segments after 6 to 12 months. Implantation of nitinol self-
expanding stents in infra-inguinal arterial segments has improved intermediate and long-term patency 
compared with PTA, but the benefit has been limited by 30% to 40% restenosis and 5% to 15% stent 
fracture rates. 
Neointimal hyperplasia remains one of the major stumbling blocks of all endoluminal therapies, 
particularly in the small caliber peripheral vessels and long diseased segments. To date, most trials 
involving drug-coated or drug-eluting stents have not shown reduced restenosis rates in the superficial 
femoral or proximal popliteal arteries.   
Preliminary data suggest that drug-coated balloons using paclitaxel reduce restenosis and late lumen loss 
in the superficial femoral and proximal popliteal arteries when compared to PTA with standard balloon 
catheters. Therefore, the drug-coated balloons may have more advantages than angioplasty alone, 
especially in terms of controlling neointimal hyperplasia and lowering restenosis rates.   
Overall Residual Risk Determination and Discussion 
The risks associated with the use of the CVT Everolimus-coated PTCA Balloon Catheter were evaluated 
for the intended use listed on page one of this risk management and for deliberate mis-use of the device.  
The analysis yielded three overall residual risk hazardous situations and resulting harms that are 
categorized as “High”: 
 
ID 
Hazard 
Event 
Hazardous 
Situation(s) 
Potential Harm Rate of 
Occurence 
2c 
Cardiovascular 
complication 
Catheter 
deployment or post 
lesion treatment 
Dissection 
Ischemia/ 
Myocardial 
Infarction (MI) 
>1% and <10% 
2d 
Cardiovascular 
complication 
Post procedure 
complication 
Thrombosis, 
persistent vessel 
occlusion 
Myocardial 
Infarction (MI) 
>0.1% and <1% 
3f 
Cardiac 
complication 
Peri procedure, 
post procedure 
complication 
Major thrombosis 
Acute MI 
Death 
>0.1% and <1% 
 
 
 

Chansu Vascular Technologies, LLC 
The CVT-ISR Trial 
TP1125 Revision A 
 
CONFIDENTIAL 
Page 72 of 74 
 
These risks are inherent to the percutaneous interventional procedure and are not specific to the CVT-
Everolimus coated balloon catheter.  The use of the CVT-Everolimus coated catheter is not anticipated 
to increase the occurrence of the hazardous situations identified compared to current percutaneous 
interventional techniques (PTCA and stenting) and, based on everolimus and everolimus-coated 
balloon studies conducted to date as well as currently marketed everolimus-coated balloon catheters, 
will provide a benefit to patients by reducing or eliminating the occurrence of restenosis. 
Conclusion 
The potential patient benefit of restoring blood flow to the occluded vessel and 
minimizing the restenosis currently observed with non-drug coated PTCA catheters and 
stenting outweighs the incidence and severity of these risks. 
 
 

Chansu Vascular Technologies, LLC 
The CVT-ISR Trial 
TP1125 Revision A 
 
CONFIDENTIAL 
Page 73 of 74 
 
APPENDIX K: GENERAL SAFETY AND PERFORMANCE REQUIREMENTS STATEMENT 
 
Compliance with REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
 
1. The CVT device has been designed, manufactured and tested in such a way that, when used under 
the conditions and for the purposes intended, it should not compromise the clinical condition or the 
safety of patients, or the safety and health of users or, where applicable, any risks which may be 
associated with their use constitute acceptable risks when weighed against the benefits to the patient 
and are compatible with a high level of protection of health and safety.  
2. The solutions adopted by CVT for the design and construction of the device conform to safety 
principles, taking account of the generally acknowledged state of the art practices for the device’s 
intended use. 
3. The device has been pre-clinically tested to achieve the performances intended by CVT and it is 
packaged accordingly.  
4. The characteristics and performances of the device have been tested to not adversely affect or 
compromise the clinical conditions and safety of the patients during its lifetime or when it is 
subjected to the stresses, which can occur during normal conditions of use. 
5. The CVT device has been designed, manufactured and packaged in such a way that its 
characteristics and performances during its intended use will not be adversely affected during 
transport and storage taking account of the instructions and information provided by CVT.  
6. The CVT device is designed and manufactured with materials that guarantee its characteristics and 
performances while meeting all required standards regarding toxicity 
and biocompatibility.  
7. The CVT device is designed and manufactured in such a way that it can be used safely with the 
materials, substances and gases with which it enter into contact during their normal use or during 
routine procedures.  
8. The CVT device is delivered in a sterile state; it is designed, manufactured and packaged in a non-
reusable package and remains sterile, under the storage and transport conditions identified, until the 
protective packaging is damaged or opened.  It has been manufactured and sterilized by an 
appropriate, verified method.  
9. The Information (Instructions for use and device labels) supplied by CVT with each device meet all 
the essential requirements. 
 
 

Chansu Vascular Technologies, LLC 
The CVT-ISR Trial 
TP1125 Revision A 
 
CONFIDENTIAL 
Page 74 of 74 
 
APPENDIX L: CASE REPORT FORMS: FRM1123 
(Note : the document included or referenced in this appendix is a controlled document ; the version in this 
appendix may not be the most current version. Contact the Sponsor or site coordinator for confirmation of 
the most current revision.) 
 

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 1 of 28
Inclusion Criteria Form
Inclusion Criteria:  All items must be answered YES for subject to be eligible.
1.
Subject must be at least 18 years of age.
2.
Subject or his/her legally authorized representative provides written informed consent prior 
to any clinical investigation related procedure, as approved by the appropriate Ethics 
Committee of the respective clinical site.
3.
Subject must agree to undergo all clinical investigation plan-required follow-up visits, 
angiograms, IVUS/OCT and examination.
4.
Target Lesion must be located within a stent (bare metal or drug eluting) placed in a native 
epicardial coronary vessel with visually estimated nominal vessel diameter of ≥2.00mm 
and ≤3.5mm.
5.
Target lesion must measure ≤ 24mm in length by visual estimation
6.
Target lesion(s) must be with a visually estimated stenosis of ≥50% and <100% with a 
TIMI flow of ≥1
7.
Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is 
allowed if done ≥ 90 days prior to or if planned to be done 6 months after the index 
procedure.
8.
Non-Clinical Investigation, percutaneous intervention for lesions in the target vessel is 
allowed if planned to be done 6 months after the index procedure.
Were all of the inclusion criteria met? 
YES   
NO
If no, which criteria were violated (indicate all that apply): _____________________

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 2 of 28
Exclusion Criteria Form
Exclusion Criteria:  All items must be answered NO for subject to be eligible.
1.
Subject has had a known diagnosis of acute myocardial infarction (AMI) within 30 days 
preceding the index procedure and CK and CK-MB have not returned within normal limits 
at the time of procedure.
2.
The subject is currently experiencing clinical symptoms consistent with AMI
3.
Subject has current unstable arrhythmia
4.
Subject has a known left ventricular ejection fraction (LVEF) < 25%.
5.
Subject has a known hypersensitivity or contraindication to aspirin, both heparin and 
bivalirudin, both clopidogrel and ticlopidine, and structurally related compounds, 
everolimus or contrast sensitivity that cannot be adequately pre-medicated.
6.
Subject has known renal insufficiency (e.g., serum creatinine level of more than 2.5 
mg/dL, (i.e. 221 μmol/L) within 7 days prior to index procedure or subject on dialysis)..
7.
Subject has a history of bleeding diathesis or coagulopathy or will refuse blood 
transfusions
8.
Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological 
attack (TIA) within the past six months.
9.
Subject has other medical illness (e.g., cancer or congestive heart failure) or known history 
of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the 
clinical investigation plan, confound the data interpretation or is associated with a limited 
life expectancy (i.e., less than one year).
10. Subject is already participating in another clinical investigation that has not yet reached its 
primary endpoint
11. Subject is not in the opinion of the investigator an acceptable candidate to participate in the 
study.
12. In stent lesions for stent located within an arterial or saphenous vein graft.
13. The target vessel contains visible thrombus.
14. Pregnant or lactating females.
Were any of the exclusion criteria met? 
YES   
NO
If yes, which criteria were violated (indicate all that apply): _____________________

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 3 of 28
Pre-Screening & Enrollment Form
Date Subject Signed Informed Consent:
|___|___| |___|___| |___|___|___|___|
DD
MM
YYYY
Date of Subject Visit (when the following data was collected): |___|___| |___|___||___|___|___|___|
              DD      MM      YYYY
Demographics
1.
Year of Birth:
|___|___|___|___|
                 YYYY
2.
Sex:
Male
Female
3.
Ethnicity:
Hispanic or Latino
Not Hispanic or Latino
4.
Subject’s self-determination of geographic ancestry:  
African
European 
Asian 
Pacific Islander 
Americas
Unknown
Baseline Measurements
1.
Weight:
__________ kg
Not Done
                 
2.
Height:
__________ cm
Not Done
3.
Blood Pressure: ________ / ________ mmHg
Not Done
(Systolic) (Diastolic)
Lead Electrocardiogram Report
ECG Performed
YES
NO
DATE
__ __ / __ __ / __ __ __ __  
(dd/mm/yyyy)
Abnormal Q-waves      
YES
NO
Abnormal ST segment changes   
YES    
NO
Abnormal T wave inversion
YES    
NO

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 4 of 28
Medical History Form
Note: Peripheral Vascular History is collected on a separate form.
1. Has the subject ever smoked? 
YES   
NO
2. Does the subject currently smoke? 
YES   
NO
Check if 
History
Check if No 
History
Diagnosis or Abnormality
1.
տ
տ
Peripheral Vascular Disease
2.
տ
տ
Hypertension
3.
տ
տ
Hyperlipidemia
4.
տ
տ
Angina Pectoris
5.
տ
տ
Previous Percutaneous or Surgical Coronary 
Revascularization
(If History When: ___________________)
6.
տ
տ
Congestive Heart Failure
7.
տ
տ
Renal Insufficiency
8.
տ
տ
Liver Disease
9.
տ
տ
Cerebrovascular disease (known carotid artery disease, 
history of minor or major stroke or transient ischemic attack)
10.
տ
տ
Chronic Obstructive Pulmonary Disease (COPD)
11.
տ
տ
Obesity
12.
տ
տ
Deep Vein Thrombosis

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 5 of 28
Medical History (Continued)
13. Previous Q wave or non-Q wave MI? 
Yes (if yes when)
No
Unknown
              13.1. Most recent MI date: ______/______/______ (dd/mmm/yyyy)
14. History of prior percutaneous coronary revascularization? 
Yes 
No 
Unknown
     14.1. Was the target vessel revascularized? 
Yes 
No 
Unknown
14.1.1. Method of revascularization:
PTCA 
Stenting
15. History of prior CABG? 
             
Yes    
No
16. Diabetes mellitus? 
Yes 
No 
Unknown
      4.1. Most recent pre-hospital treatment: 
Insulin
Oral antidiabetic agents 
Diet
17. Is there premature CAD in a first-degree relative? 
Yes 
No 
Unknown
18. Number of diseased major coronary arteries that have received catheter treatment:
0 
1 
2 
3             
Assessment of Anginal Status
19. 
Stable angina 
Unstable angina   MI
20. Worst Canadian Cardiovascular Society Class leading to this revascularization: 
CCS 0 
CCS1 
CCS2 
CCS3 
CCS 4 UNK
21. Did the patient have a positive stress test? 
YES
NO 
UNK

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 6 of 28
Pre-Procedure Laboratory Blood Values
1.
Is the subject female and of childbearing potential? 
YES   
NO
NA (if Male)
                 
1.1.
If yes, sample date of pregnancy test: |___|___| |___|___| |___|___|___|___|
DD
MM
YYYY
1.2.
Result of pregnancy test: 
Postive   
Negative 
Not Done
Blood Test Sample Date: |___|___| |___|___| |___|___|___|___|
DD
MM
YYYY
Parameter
Result
Unit
Range
Clinically 
Significant
(if out of range)
Yes           No
Comment
or Not Done
IN
OUT
High   Low
WBC
          
               
Not Done
Differential WBC
    Eosinophils
            
               
Not Done
    Basophils
            
               
Not Done
    Neutrophils
            
               
Not Done
    Monocytes
            
               
Not Done
    Lymphocytes
            
               
Not Done
Hemoglobin
            
               
Not Done
Hematocrit
            
               
Not Done
Absolute Platelet 
Count
            
               
Not Done
Serum Creatinine
            
               
Not Done
Prothrombin Time
            
               
Not Done
Activated 
Prothrombin Time
            
               
Not Done

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 7 of 28
CK and/or CK-MB cardiac Troponin
Not done.
Cardiac 
Enzymes
Date of Test:
(dd/mm/yyyy)
Time
(24 hour clock)
Value
(U/L)
Upper Normal 
Limit (U/L)
CK
__ __/__ __/__ __ __ __
__ __ : __ __
CK-MB
__ __/__ __/__ __ __ __
__ __ : __ __
Troponin
__ __/__ __/__ __ __ __
__ __ : __ __

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 8 of 28
Antiplatelet and Anticoagulant Medication
1.
Was Aspirin Administered
YES   
NO
2.
Was an Antiplatelet Administered 
  
YES   
NO
3.
What anticoagulant was administered: ________________________________________
4.
Was a glycoprotein (GP) IIb/IIIa receptor blocker used:  
YES
NO

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 9 of 28
Procedural Form
Target Lesion Treatment DCB # 1
DCB # 2 
1.
What was the location of vascular access
Femoral 
Radial    
Brachial
2.
Arterial sheath size 
5F 
6F    
7F 
8F
3. ISR Stent Location
Right Coronary Artery           
Left Anterior Descending 
Circumflex.
Proximal 
Mid
Distal      
Proximal  
Mid
Distal
Proximal  
Mid
Distal 
Right Post. Descending          
Diagonal branch                    
Obtuse Marginal
4.
Type of stent with ISR: 
BMS  
DES Sirolimus  
DES Everolimus
DES Paclitaxel
DES Zotarolimus
DES other drug Specify _________
5.
Angiographic Assessment 
Visual 
QCA
5.1
Reference Vessel Diameter ______mm
5.2
Minimum Luminal Diameter in Lesion______mm 
5.3
Lesion Length ______mm
5.4
% Diameter stenosis ______mm
6.
CVT DCB Lot #______________ and serial number ______________ (if applicable) 
7.
CVT DCB Size:
8.
Maximum pressure used with: 
__________ (atm)
9.
a.  Time device entered the vasculature (HH:MM): 
__ __: __ __
b.  Time the device was inflated (HH:MM):
__ __: __ __
c.  Was the balloon inflated against the vessel wall for 1 minute or more?    
YES  
NO
d.  Duration the balloon was inflated (minutes: seconds)
__ __: __ __
10.
Percent stenosis after the CVT DCB Deployment:
__________ %
11.  Dissection after this catheter treatment (Grade):    
0/Not Applicable 
A
B   
C
D
E
F

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 10 of 28
Procedural Form (Continued)
12. Treatment required to treat dissection:   
YES 
NO
N/A
13.1.  If yes specify device used __________________________________________
13.2.  If stent used, what type of stent BMS 
DES Specify __________
13.
Was the target lesion post-dilated following the use of DCB # 1?
YES 
If NO, go to question 2. 
13.1.
If yes:
Balloon diameter :  _____mm
Balloon length : _______mm
13.2.
Maximum pressure used:__________ (atm)
13.3.
Percent stenosis after post-dilatation (visual estimate): 
__________ %
13.4.
Dissection after post-dilatation (grade):
0/Not Applicable 
A 
B 
C 
D 
E 
F
14. 
Treatment required to treat dissection:   
YES 
NO
N/A
14.1.  If yes specify device used __________________________________________
14.2.  If stent used, what type of stent BMS 
DES Specify __________
15.
Indicate the final percent stenosis of target lesion after all treatment (pre-dilatation, 
treatment catheter, post-dilatation and, if applicable, stenting): _____________ %

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 11 of 28
Procedural Form (Continued)
Check if the subject had a second balloon used and complete a second procedural form.
Post-Index Procedure Angiography
16.Was an angiogram of the study lesion captured during the procedure per angiographic core   
lab instructions ? 
YES 
NO
a.
     If yes, was the angiogram sent or uploaded to the core lab?  
YES 
NO

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 12 of 28
Pre-Hospital Discharge Form
Date of Subject Discharge:
|___|___| |___|___| |___|___|___|___|
DD
MM
YYYY
Blood Assessment
1.
Were blood labs taken post-procedure and pre-discharge?
YES
NO
If yes, complete the Laboratory Blood Values Form.
CK and/or CK-MB cardiac Troponin
Cardiac 
Enzymes
Date of Test:
(dd/mm/yyyy)
Time
(24 hour clock)
Value
(U/L)
Upper Normal 
Limit (U/L)
CK
__ __/__ __/__ __ __ __
__ __ : __ __
CK-MB
__ __/__ __/__ __ __ __
__ __ : __ __
Troponin
__ __/__ __/__ __ __ __
__ __ : __ __
12-Lead Electrocardiogram Report
ECG Performed
YES
NO
DATE
__ __ / __ __ / __ __ __ __  
(dd/mm/yyyy)
Abnormal Q-waves      
YES  
NO
Abnormal ST segment changes   
YES    
NO
Abnormal T wave inversion
YES    
NO
Reminder:  Record all medications including study medications on the Concomitant 
Medications Log.  Record all adverse events unresolved as of the end of the index procedure
through discharge on the Adverse Events Log.

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 13 of 28
Medications
Time point: 
Pre-discharge
1 month follow up 
6 Month follow up 
                     
12 Month follow up 
24 Month follow up 
36 Month follow up
Medications
Pre-Procedure
During 
Procedure
Post-Procedure
ASA
  YES 
  NO
UNK
  YES 
  NO
UNK
Clopidogrel
  YES 
  NO
UNK
  YES 
  NO
UNK
  YES 
  NO
UNK
Ticlopidine
YES 
  NO
UNK
  YES 
  NO
UNK
  YES 
  NO
UNK
Other Anti coagulants
  YES 
  NO
UNK
  YES 
  NO
UNK
  YES 
  NO
UNK
IIb/IIIa Inhibitors

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 14 of 28
1 Month Follow-up Visit
Date of Subject Visit:
|___|___| |___|___| |___|___|___|___|
DD
MM
YYYY
  Check if the visit was not performed
General Assessment
1.
Did the subject visit the clinic?
YES
If NO, was the visit conducted via telephone? 
YES 
  NO
2.
Were current medications discussed?
If YES, update the Concomitant Medications Log as appropriate 
NO
3.
Was the subject asked if any adverse events occurred from the last study visit
If YES, update the Adverse Event Log as appropriate 
NO
4.
Did the subject have any coronary reinterventions since the last study visit?
If YES, complete the Intervention/Revascularization Form and record the precluding 
adverse event on the Adverse Event Log
NO
12-Lead Electrocardiogram Report
ECG Performed
YES
NO  
NA
DATE
__ __ / __ __ / __ __ __ __  
(dd/mm/yyyy)
Abnormal Q-waves      
YES    
NO
Abnormal ST segment changes   
YES    
NO
Abnormal T wave inversion
YES    
NO

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 15 of 28
6 Month Follow-up visit
Date of Subject Visit:
|___|___| |___|___| |___|___|___|___|
Not Done
DD
MM
YYYY
Clinical Follow up 
1.
Were current medications discussed?
If YES, update the Concomitant Medications Log as appropriate 
NO
2.
Was the subject asked if any adverse events occurred from the last study visit?
If YES, update the Adverse Event Log as appropriate 
NO
3.
Did the subject have any reinterventions since the last study visit?
If YES, complete the Intervention/Revascularization Form and record the precluding 
adverse event on the Adverse Event Log
NO
12-Lead Electrocardiogram Report
ECG Performed
YES
NO
DATE
__ __ / __ __ / __ __ __ __  
(dd/mm/yyyy)
Abnormal Q-waves      
YES   
NO
Abnormal ST segment changes   
YES    
NO
Abnormal T wave inversion
YES    
NO
Angiographic Follow up 
1. Was angiographic follow-up performed?   
YES    
NO
2. Was IVUS performed per laboratory guidelines?  
YES    
NO
3. Was OCT performed per core laboratory guidelines?  
YES    
NO
4. Were results sent to the core laboratory? 
YES    
NO

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 16 of 28
12 Month Follow-up Visit
Date of Subject Visit/Contact:
|___|___| |___|___| |___|___|___|___| 
Not Done
DD
MM
YYYY
  Check if Follow-up (12 months) was not performed and leave the rest of the page blank.
General Assessment
1.
Did the subject visit the clinic?
(1) YES 
(2) If NO, was the visit conducted via telephone? 
(1) YES 
(2)  NO
2.
Were current medications discussed?
If YES, update the Concomitant Medications Log as appropriate 
NO
3.
Did any adverse events occur since last study visit?
If YES, update the Adverse Event Log
NO
Did not discuss
4.
Did the subject have any reinterventions since the last study visit?
If YES, complete the Intervention/Revascularization Form and record the precluding 
adverse event on the Adverse Event Log
NO
12-Lead Electrocardiogram Report
ECG Performed
YES
NO  
NA
DATE
__ __ / __ __ / __ __ __ __  
(dd/mm/yyyy)
Abnormal Q-waves      
YES   
NO
Abnormal ST segment changes   
YES    
NO
Abnormal T wave inversion
YES    
NO

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 17 of 28
24 Month Follow-up Visit
Date of Subject Visit:
|___|___| |___|___| |___|___|___|___|
DD
MM
YYYY
Check if the visit was not performed
General Assessment
1.
Did the subject visit the clinic?
YES 
If NO, was the visit conducted via telephone? 
YES 
  NO
2.
Were current medications discussed?
If YES, update the Concomitant Medications Log as appropriate 
NO
3.
Was the subject asked if any adverse events occurred from the last study visit?
If YES, update the Adverse Event Log as appropriate 
NO
4.
Did the subject have any reinterventions since the last study visit?
If YES, complete the Intervention/Revascularization Form and record the precluding 
adverse event on the Adverse Event Log
NO
12-Lead Electrocardiogram Report
ECG Performed
YES
NO  
NA
DATE
__ __ / __ __ / __ __ __ __  
(dd/mm/yyyy)
Abnormal Q-waves      
YES   
NO
Abnormal ST segment changes   
YES    
NO
Abnormal T wave inversion
YES    
NO

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 18 of 28
36 Month Follow-up Visit
Date of Subject Visit:
|___|___| |___|___| |___|___|___|___|
DD
MM
YYYY
  Check if the visit was not performed
General Assessment
1.
Did the subject visit the clinic?
YES 
If NO, was the visit conducted via telephone? 
YES 
  NO
2.
Were current medications discussed?
If YES, update the Concomitant Medications Log as appropriate 
NO
3.
Was the subject asked if any adverse events occurred from the last study visit?
If YES, update the Adverse Event Log as appropriate 
NO
4.
Did the subject have any reinterventions since the last study visit?
If YES, complete the Intervention/Revascularization Form and record the precluding 
adverse event on the Adverse Event Log
NO
12-Lead Electrocardiogram Report
ECG Performed
YES
NO  
NA
DATE
__ __ / __ __ / __ __ __ __  
(dd/mm/yyyy)
Abnormal Q-waves      
YES   
NO
Abnormal ST segment changes   
YES    
NO
Abnormal T wave inversion
YES    
NO

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 19 of 28
Study Completion/Termination Form
1.
Did the subject complete the entire course of the study? 
YES 
NO
1.1.
If yes, date of subject completion:
|___|___| |___|___| |___|___|___|___|
DD
MM
YYYY
1.2.
If no, date of subject termination:
|___|___| |___|___| |___|___|___|___|
DD
MM
YYYY
1.2.1.
Reason for termination (mark only one)
Withdrawal of Consent by the Subject
Lost-to-follow-up 
Date of last contact:  |___|___| |___|___| |___|___|___|___|
DD
MM
YYYY
Other-Specify: _____________________________________________
Death
Date of Death: |___|___| |___|___| |___|___|___|___|
DD
MM
YYYY
Primary Cause of death: _______________________________
Underlying cause(s) of death: ___________________________
Was death related to the study product?  
YES 
NO
Was death related to the study procedure?  
YES       
NO
2.
Were any Adverse Events Reported during the course of the study?
If YES, ensure the Adverse Event Log is up to date.
NO

CVT ISR Trial FIH Trial Protocol Number: TP1125 
  
Case Report Forms 
 
Site ID __ __ __ __ 
Subject Number __ __  
Birth Year __ __ __ __ 
 
 
 
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021 
Page 20 of 28 
 
CRF Completion Acknowledgement  
 
 
 
To be completed by the Investigator: 
 
I have assumed responsibility for completeness and accuracy of all data recorded in these Case 
Report Forms. 
 
 
 
 
 
Investigator’s Name – Print Clearly 
 Investigator’s Signature 
 
 
 Date:  |___|___| |___|___| |___|___|___|___| 
 
DD 
MM 
YYYY 
 
 
 
 
 

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 21 of 28
Comment Log
Use this form to explain any subject, drug, or product related events that occurred during the 
study that are not noted elsewhere.  Indicate the CRF page number(s) and if applicable study 
visits to which the comment refers in the appropriate column.  Provide description of the event,
initials of the study personnel, note the action taken, if any. 
  Check if there are not any comments
CRF
Page
Comment
Person 
Recording 
Comment

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 22 of 28
Concomitant Medications Log
Concomitant 
Medication #
Drug Name
(Generic)
Reminder: Include study 
medications such as aspirin 
and clopidogrel.  Number all 
medications in chronological 
order.
Dose
Unit
Frequency
(See * 
Below)
Route 
(See ** 
Below)
Indication 
(check one per line)
Start Date 
(DD/MM/
YYYY)
Stop Date 
(DD/MM/
YYYY)
Check if 
Continuing at 
Study Termination
Existing 
Condition
Adverse 
Event
Prophylaxis
Study 
Medication
տ
տ
տ
տ
____/____/
_______
Unknown
____/____/
______
Unknown
տ
տ
տ
տ
տ
____/____/
_______
Unknown
____/____/
______
Unknown
տ
տ
տ
տ
տ
____/____/
_______
Unknown
____/____/
______
Unknown
տ
տ
տ
տ
տ
____/____/
_______
Unknown
____/____/
______
Unknown
տ

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 23 of 28
տ
տ
տ
տ
____/____/
_______
Unknown
____/____/
______
Unknown
տ
տ
տ
տ
տ
____/____/
_______
Unknown
____/____/
______
Unknown
տ
տ
տ
տ
տ
____/____/
_______
Unknown
____/____/
______
Unknown
տ
* Frequency:
QD = once daily
BID = twice daily
TID = three times a day
QOD = every other day
QID = four times a day
QHS = every night
PRN = as needed
Other = not listed
** Route:
IM = intramuscular
INH = inhalation
IV = intravenous
PO = oral
SC = subcutaneous
SL = sublingual
TOP = topical
Other = not listed
Instructions: Each concomitant 
medication is to be numbered sequentially.

CVT ISR Trial FIH Trial Protocol Number: TP1125 
  
Case Report Forms 
 
Site ID __ __ __ __ 
Subject Number __ __  
Birth Year __ __ __ __ 
 
 
 
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021 
Page 24 of 28 
 
 Adverse Event Log 
AE Number 
Study Limb 
Adverse Event 
(Describe Event) 
 
Reminder: List adverse events 
in order by adverse event 
number. 
Onset Date 
(DD/MM/YYYY) 
Timing of 
Event 
(choose 
one) 
Resolution 
Date 
(DD/MM/
YYYY) 
Severity 
(choose one) 
Freq
uenc
y 
 
See 
Code
s 
Belo
w 
Serious  
Adverse 
Event 
(choose one) 
Relationshi
p  
See Codes 
Below  
Out
com
e 
 
See 
Cod
es 
Belo
w 
Check if Transfusion 
due to AE 
Intra-Op 
Post-Op 
Mild 
Moderate 
Severe 
No 
If yes, 
See 
Codes 
Below 
to Study 
Device 
To Study 
Procedure 
 
 
 
____/____/______ 
տ 
տ 
____/____/
________ 
տ 
տ 
տ 
 
տ 
 
 
 
 
տ 
 
 
 
____/____/______ 
տ 
տ 
____/____/
________ 
տ 
տ 
տ 
 
տ 
 
 
 
 
տ 
 
 
 
____/____/______ 
տ 
տ 
____/____/
________ 
տ 
տ 
տ 
 
տ 
 
 
 
 
տ 
 
 
 
____/____/______ 
տ 
տ 
____/____/
________ 
տ 
տ 
տ 
 
տ 
 
 
 
 
տ 
 
Study Limb 
Severity 
Frequency 
Serious Adverse Event Codes 
Relationship 
Outcome 
Indicate if 
the event 
occurred in 
Mild = Awareness of a sign or 
symptom that does not interfere 
with the subject’s usual activity or 
1 = Single 
episode 
2 = Intermittent 
A = Results in death 
B = Is life-threatening 
C = Permanent impairment of a 
1 = Not 
Related 
2 = Unlikely 
1 = Recovered/resolved 
 2 = Recovered with 
sequelae 

CVT ISR Trial FIH Trial Protocol Number: TP1125 
  
Case Report Forms 
 
Site ID __ __ __ __ 
Subject Number __ __  
Birth Year __ __ __ __ 
 
 
 
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021 
Page 25 of 28 
 
the study 
Limb. 
Y=Yes 
N=No 
NA=Not 
Applicable 
is transient, resolved without 
treatment and with no sequelae. 
Moderate = Interferes with the 
subject’s usual activity and/or 
requires symptomatic treatment. 
Severe = Symptom(s) causing 
severe discomfort and significant 
impact of the subject’s usual 
activity and requires treatment. 
3 = Continuous 
body structure or function 
D = In-patient or prolonged 
hospitalization 
E = Medical/surgical intervention 
to prevent life-threatening illness or 
injury or permanent impairment 
F = Led to fetal distress, fetal death 
or congenital abnormality or birth 
defect 
3 = Possible 
4 = Probable 
5 = Highly 
Probable 
3 = Not 
recovered/not 
resolved 
4 = Ongoing (at 
study termination) 
6 = Fatal 
7 = Unknown 

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 26 of 28
Intervention/Revascularization Form
Revascularization #__________
1. Revascularization date:
|___|___| |___|___| |___|___|___|___|
DD
MM
YYYY
1. Was the revascularization involving the target lesion? 
YES
NO   
Not Applicable
2. Was the target lesion revascularization ischemia driven? 
YES
NO   
Not 
Applicable
Location
1=Right Coronary
2=Left Anterior 
Descending
3=Circumflex
Intervention 
Performed
(mark only one)
1=Angioplasty
2=Stent (Bare)
3=Stent (Drug Eluting)
4=Other, specify
Reason for 
Intervention 
(mark only one)
1=Occlusion
2=Stenosis
3=Thrombosis
4=Other, specify
Was the 
Intervention 
Successful? (≤ 
50% stenosis)
Was the 
Intervention 
Clinically 
Driven?
(1)   (2)   (3)    
(1)    (2)    (3)    
(4) ______________
(1)    (2)    
(3)    
(4) _________
(1) Yes
(2) No
(1) Yes
(2) No
(1)   (2)   (3)    
(1)    (2)    (3)    
(4) ______________
(1)    (2)    
(3)    
(4) _________
(1) Yes
(2) No
(1) Yes
(2) No
(1)   (2)   (3)    
(1)    (2)    (3)    
(4) ______________
(1)    (2)    
(3)    
(4) _________
(1) Yes
(2) No
(1) Yes
(2) No
(1)   (2)   (3)    
(1)    (2)    (3)    
(4) ______________
(1)    (2)    
(3)    
(4) _________
(1) Yes
(2) No
(1) Yes
(2) No
Angiographic Assessment
1.
Was an angiogram of the study lesion(s) captured during this visit?
YES 
NO
1.1. Was the angiogram sent or uploaded to the core lab?
YES
NO

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 27 of 28
Serious Adverse Event Notification Form
Serious Adverse Type: _____________
1. Reason for SAE: (choose one)
Resulted in Death
Is Life-threatening
Required inpatient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant disability/incapacity 
2. Date of report:
|___|___| |___|___| |___|___|___|___|
DD
MM
YYYY
3. Date of adverse event onset:
|___|___| |___|___| |___|___|___|___|
DD
MM
YYYY
4. Type of report:
Initial
Follow-up
5. Diagnosis/Adverse Event (Name must match the AE found on the Adverse Event 
Log):
__________________________________________________________________
6. Symptoms (if applicable): 
NA
Relationship to study device (check only one):
Not Related
Unlikely Related
Possibly Related
Probably Related
Highly Probable Related
7. Relationship to study procedure (check only one):
Not Related
Unlikely Related
Possibly Related
Probably Related
Highly Probable Related
8. Frequency of event:
Single episode    
Intermittent    
Continuous
9. Outcome of event at this time: 
Recovered/resolved
Recovered with sequelae
Not recovered/not resolved
Ongoing
Fatal 
Unknown

CVT ISR Trial FIH Trial Protocol Number: TP1125
Case Report Forms
Site ID __ __ __ __
Subject Number __ __ 
Birth Year __ __ __ __
FRM1123 Rev. 01, DCO#0031.  Effective Date: 09-Jun-2021
Page 28 of 28
Serious Adverse Event Notification Form (continued)
Note: if the event is later “Recovered/resolved” or “Recovered with sequelae” 
leave question 9 as is and indicate the date of resolution/recovery below.
9.1
If Recovered/resolved or Recovered with sequelae indicate the date 
resolved:
|___|___| |___|___| |___|___|___|___|
DD
MM
YYYY
10. If subject died, date of death: |___|___| |___|___| |___|___|___|___|  
NA
DD
MM
YYYY
If died, cause of death: 
11. Treatment given (mark all that apply):
None
Medication
Surgery
Reintervention 
Other, specify: ___________________
12. Please describe event in chronological order (include relevant medical history, 
relevant dates [e.g., hospitalization], reasons for causality assessment, signs, 
symptoms, labs, and relative treatment):
   
|___|___| |___|___| |___|___|___|___|
Investigator Signature
DD
MM
YYYY