Chansu Vascular Technologies Everolimus-Coated Balloon Percutaneous Transluminal Angioplasty Catheter First-in-Human Clinical Investigation
Phase: NA
Conditions: Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
Sponsor: Abbott Medical Devices

Chansu Vascular Technologies Everolimus-Coated Percutaneous Transluminal 
Angioplasty Catheter First-in-Human Clinical Investigation 
The CVT-SFA Trial
PROTOCOL
Protocol Number:
TP1109
Revision:
E
Lead Principal Investigator:
Data Management/Data Analysis:
Duplex Ultrasound Core Laboratory:
Sponsor:
Chansu Vascular Technologies LLC
DCO Number, Effective Date:
, 02-Aug-2022

Chansu Vascular Technologies, LLC 
The CVT-SFA Trial 
TP1109 Revision E 
 
Confidential 
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TABLE OF CONTENTS 
PROTOCOL SIGNATURE PAGE ...................................................................................................... 5 
REVISION HISTORY ........................................................................................................................... 6 
PROTOCOL SUMMARY ..................................................................................................................... 7 
1. 
STUDY OVERVIEW AND RATIONALE ............................................................................... 11 
1.1. 
Study Overview .................................................................................................................... 11 
1.2. 
Background and Literature Review ..................................................................................... 11 
1.3. 
Study Rationale ................................................................................................................... 13 
2. 
DESCRIPTION OF THE STUDY DEVICE ............................................................................. 13 
2.1. 
Basic Catheter Specifications .............................................................................................. 14 
2.2. 
Indication ............................................................................................................................ 14 
3. 
STUDY DESIGN .......................................................................................................................... 15 
3.1. 
Primary Endpoints .............................................................................................................. 15 
3.2. 
Secondary Endpoints ........................................................................................................... 16 
3.3. 
Study Population ................................................................................................................. 17 
3.4. 
Ethical Considerations ........................................................................................................ 17 
3.5. 
Subject Inclusion Criteria ................................................................................................... 17 
3.6. 
Subject Exclusion Criteria .................................................................................................. 18 
3.7. 
Subject Enrollment Point .................................................................................................... 18 
3.8. 
Subject Discontinuation ...................................................................................................... 19 
3.9. 
Early Termination of the Clinical Study .............................................................................. 20 
4. 
CONDUCT OF THE STUDY ..................................................................................................... 20 
4.1. 
Baseline Assessments ........................................................................................................... 20 
4.2. 
Concomitant Medical Therapy ............................................................................................ 21 
4.3. 
SFA PTA Procedure ............................................................................................................. 22 
4.4. 
Post-Procedure Subject Management ................................................................................. 23 
4.5. 
Pre-Discharge Assessments ................................................................................................. 24 
4.6. 
Subject Follow-up Post Hospital Discharge ....................................................................... 25 
5. 
ADVERSE EVENTS ................................................................................................................... 28 
5.1. 
Adverse Events .................................................................................................................... 28 
5.2. 
Anticipated Adverse Events ................................................................................................. 28 
5.3. 
Adverse Event Severity ........................................................................................................ 31 
5.4. 
Relationship to Study Device ............................................................................................... 31 
5.5. 
Serious Adverse Events ........................................................................................................ 33 
5.6. 
Procedures for Reporting Serious Adverse Event ............................................................... 33 
6. 
STATISTICAL DESIGN AND ANALYSIS ............................................................................. 34 
6.1. 
Statistical Overview of the Trial .......................................................................................... 34 

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6.2. 
Analysis Populations ........................................................................................................... 34 
6.3. 
Sample Size Justification ..................................................................................................... 35 
6.4. 
Statistical Analyses .............................................................................................................. 36 
7. 
RISK ASSESSMENT .................................................................................................................. 37 
7.1. 
Potential Risks from Peripheral Catheterization, Stenting and PTA .................................. 37 
7.2. 
Potential Risks from Everolimus Coating ........................................................................... 37 
7.3. 
Risk Management Procedure .............................................................................................. 39 
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 ........................................................................................................ 39 
8.3. 
Reports ................................................................................................................................ 39 
9. 
REGULATORY REQUIREMENTS ......................................................................................... 39 
9.1. 
Investigator’s Responsibility ............................................................................................... 39 
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 .................... 42 
10.1. 
Role of Sponsor ................................................................................................................ 42 
10.2. 
Investigator's Brochure ................................................................................................... 43 
10.3. 
Documentation ................................................................................................................ 43 
10.4. 
Committees ...................................................................................................................... 43 
11. TRIAL TERMINATION ............................................................................................................ 44 
12. APPENDICES .............................................................................................................................. 44 
APPENDIX A: BIBLIOGRAPHICAL REFERENCES ................................................................ 45 
APPENDIX B: TRIAL ABBREVIATIONS AND DEFINITIONS .............................................. 53 
APPENDIX C:  PATIENT INFORMED CONSENT : LBL1116 ................................................... 62 
APPENDIX D: DECLARATION OF HELSINKI ............................................................................ 63 
APPENDIX E: INSTRUCTIONS FOR USE: LBL1117 .................................................................. 68 
APPENDIX F: SCHEDULE OF EVENTS ........................................................................................ 69 
APPENDIX G: RESEARCH AGREEMENT TEMPLATE: FRM 1118 ........................................ 71 
APPENDIX H: INVESTIGATOR’S RESPONSIBILITIES ............................................................ 72 
APPENDIX I: DUPLEX ULTRASONOGRAPHY CORE LAB GUIDELINES .......................... 74 

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APPENDIX J: RISK ANALYSIS ....................................................................................................... 75 
APPENDIX K: GENERAL SAFETY AND PERFORMANCE REQUIREMENTS 
STATEMENT ........................................................................................................................... 77 
APPENDIX L: CASE REPORT FORMS: FRM1119 ...................................................................... 78 
APPENDIX M:  ANGIOGRAPHIC CORE LAB GUIDELINES ................................................... 79 
 
TABLE OF FIGURES 
Figure 1. CVT-SFA Study Participation Flow Chart.............................................................................. 15 
 
TABLE OF TABLES 
Table 1.  CVT Everolimus-coated PTA Catheter Size Matrix and Total Drug Content ..................... 14 
Table 2.  CVT-SFA Study Pre-Procedure, Procedural, Discharge and Follow Up Activities ............. 27 
Table 3.  CVT-SFA Study Site Responsibilities for Submitting Data and Reports............................. 42 
 
 
 
 

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PROTOCOL SIGNATURE PAGE 
 
 
The CVT-SFA Trial 
Chansu Vascular Technologies Everolimus-Coated Balloon Percutaneous Transluminal 
Angioplasty Catheter First-in-Human Clinical Investigation 
 
 
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 
 
 
 
 
 
 
 

Chansu Vascular Technologies, LLC 
The CVT-SFA Trial 
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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. 
Removed angiographic core lab references. 
A 
0134 
11-Jan-2022 
Add Core Lab documents to Appendix I. Add 
Appendix M with Core Lab Guidelines.  Edit section 
4.3 which previously allowed stent placement before 
procedure. Remove DUS at Post Procedure (section 
4.3). Add risk analysis information to section J. 
B 
0159 
15-Mar-2022 
Added walking test or treadmill test to baseline 
functional status to assess walking distance (section 
4.1); added completion of walking test or treadmill 
test to 6 month and 12 month follow up (section 4.6); 
added walking test or treadmill test to Table 2 
schedule of events.  Updated planned enrollment 
schedule in protocol summary section. 
C 
0162 
24-Mar-2022 
Added stent post-dilatation clarification to use CVT 
device to section 4.3 “Criteria for Bail-Out Stenting”. 
D 
0168 
28-Apr-2022 
Revise Appendix M (angiographic core lab guideline) 
to include complete distal runoff images 
E 
0189 
02-Aug-2022 
Corrected Appendix F (Schedule of Events) to include 
Walking/Treadmill Test at 6M/12M follow up.  This 
change reflects the requirements in the body of the 
protocol and the Schedule of Events in Table 2. 
 
 

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PROTOCOL SUMMARY 
Investigational 
Device 
CVT Everolimus-coated Percutaneous Transluminal Angioplasty (PTA) 
Catheter (CVT EVE-PTA Catheter) 
Study Objective 
To assess the safety and inhibition of restenosis of the CVT Everolimus-
coated PTA Catheter in the treatment of subjects with de-novo 
occluded/stenotic or re-occluded/restenotic lesions in superficial femoral or 
popliteal arteries. 
Study Design 
Prospective, multi-center, open, single arm study 
Number of 
Subjects 
A total of 75 subjects will be enrolled 
Number of Sites 
Up to eight (8) sites in Europe  
Primary Safety 
Endpoint 
Freedom of Major Adverse Event (MAE) rate at 6 months post-procedure, 
defined as a composite rate of cardiovascular death, index limb amputation 
and ischemia-driven target lesion revascularization (TLR). 
Primary 
Effectiveness 
Endpoint 
Patency at 6 months post procedure, defined as freedom from restenosis as 
determined by duplex ultrasonography (DUS) (peak systolic velocity ratio 
(PSVR) ≤2.4 or ≤50% stenosis) and freedom from ischemia-driven target 
lesion revascularization (TLR). 
Secondary Safety 
Endpoints 
x Rate of Major Adverse Event (MAE) rate in hospital and at 30 days, 1-, 
2- and 3-years post-procedure, defined as a composite rate of 
cardiovascular death, index limb amputation and ischemia-driven Target 
Lesion Revascularization (TLR). 
x Rate of occurrence of arterial thrombosis of the treated segment. 
x Rate of ipsilateral embolic events of the study limb. 
x Rate of clinically-driven target lesion revascularization at 6, 12, 24 and 
36 months. 
x Patency rate at 12 months post procedure defined as freedom from 
clinically driven TLR and duplex ultrasonography detected restenosis 
(ultrasound peak systolic velocity ratio ≤ 2.4 or stenosis ≤50%) 
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 <50% (by QA), 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. 

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Secondary 
Endpoints 
(continued) 
x Technical success (per device), defined as achievement of a final in-
lesion residual diameter stenosis of <50% (by QA), using the CVT 
Everolimus-coated PTA 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 events during the procedure. 
x Procedural success (per subject) defined as lesion success without the 
occurrence of major adverse events during procedure. 
x Ankle-Brachial Index (ABI) changes before procedure compared with 
ABI at discharge and at 6 and 12 months. 
x Change in WIQ (walking impairment questionnaire) from pre-
intervention at 6 and12 months follow-up. 
x Change in walking distance from pre-procedure at 6 and 12 months. 
x Change in Rutherford classification grades of chronic limb ischemia from 
pre-intervention at 6 and12 months follow-up for the treated limb. 
Subject 
Population 
Subjects with documented symptomatic occlusion and/or >70% stenosis of 
the superficial femoral or popliteal (P1 segment) artery. 
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 and examinations. 
4. Subjects with symptomatic leg ischemia, requiring treatment of SFA 
or popliteal (P1 segment) artery. 
5. De novo or restenotic lesion(s) >70% within the SFA and popliteal 
arteries in a single limb which are ≥3 cm and ≤15 cm in cumulative 
total length (by visual estimation). Lesion must be at least 2 cm from 
any stented area. 
6. Subject is willing to provide informed consent and comply with the 
required follow up visits, testing schedule and medication regimen. 
7. Successful wire crossing of lesion. 
8. Target vessel reference diameter ≥4 mm and ≤6 mm (by visual 
estimation). 
9. Target lesion(s) can be treated with a maximum of two (2) CVT 
Everolimus-coated PTA Catheters. 

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10. At least one patent (less than 50% stenosis) tibio-peroneal run-off 
vessel confirmed by baseline angiography or prior MR angiography or 
CT angiography. 
11. Life expectancy >1 year 
12. Rutherford classification of 2, 3 or 4 
Exclusion Criteria 
Subject with any of the following should be excluded: 
1. Pregnant or lactating females. 
2. Co-existing clinically significant aneurismal disease of the abdominal 
aorta, iliac or popliteal arteries. 
3. Significant gastrointestinal bleeding or any coagulopathy that would 
contraindicate the use of anti-platelet therapy. 
4. Known intolerance to study medications, everolimus or contrast agents. 
5. Doubts in the willingness or capability of the subject to allow follow-up 
examinations. 
6. Subject is actively participating in another investigational device or drug 
study. 
7. History of hemorrhagic stroke within 3 months of procedure. 
8. Previous or planned surgical or interventional procedure within 30 days 
of index procedure. 
9. Prior vascular surgery of the target lesion. 
10. Lesion length is <3 cm or >15 cm or there is no normal proximal arterial 
segment in which duplex ultrasound velocity ratios can be measured. 
11. Known inadequate distal outflow. 
12. Significant inflow disease. 
13. Acute or sub-acute thrombus in target vessel. 
14. Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, 
scoring/cutting balloons, brachytherapy, lithotripsy). 
15. Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal 
arteries) with significant lesions (≥ 50% stenosis) may not be treated 
during the same procedure. 
16. Treatment of the contralateral limb during the same procedure or within 
30 days of the study procedure. 
17. Rutherford classification of 0, 1, 5 or 6 
18. Presence of prohibitive calcification that precludes adequate PTA 
treatment. 
19. Subjects held in custody in an institution by official or court order. 

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Treatment Strategy 
x Target lesion pre-dilatation will be performed to determine lesion 
treatability and prevent the need for stent implantation for treatment of 
flow limiting dissection. 
x In the absence of flow limiting dissection and if no stent has been 
needed, the target lesion will be treated with the CVT Everolimus-coated 
Balloon Catheter from healthy-to-healthy segments. 
Planned Schedule 
 
x First subject enrolled: February - 2022 
x Last subject enrolled:  October - 2022 
x Last subject last contact: November - 2025 
 
 
 
 
 

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1. 
STUDY OVERVIEW AND RATIONALE 
1.1. Study Overview 
The CVT-SFA study is a prospective, multi-center, open, single arm study which will 
include seventy-five (75) subjects at up to eight (8) sites in Europe and will evaluate an 
everolimus-coated percutaneous transluminal angioplasty (PTA) catheter for the 
treatment of de-novo occluded/stenotic or re-occluded/restenotic superficial femoral or 
popliteal arteries. 
Study enrollment will be offered to all subjects who are suitable candidates for balloon 
PTA to correct occlusive or stenotic lesions of the superficial femoral or popliteal P1 
segment artery. 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   
Peripheral artery disease (PAD) is associated to incident cardiovascular morbidity and 
mortality1 and would have affected in 2015 about 236 million people aged 25 years and 
older worldwide; women accounted around 52% of this population.2 Total disease 
prevalence has been estimated at between 3% and 10%, increasing to 15 to 20% in 
subjects over 70 years.3 Only about 25 percent of affected individuals undergo treatment 
for the disease.4 
The most common symptom of PAD is difficulty in walking (intermittent 
claudication); less common is critical limb ischemia (CLI) which includes severe, 
persistent rest pain (requiring treatment with analgesics), ulceration or gangrene of the 
distal extremity. Lower extremity arterial disease can lead to reduced mobility, limb 
pain, gangrene and amputation, as well as increased mortality3, 5, 6, 7 Subjects with PAD 
generally also present with cardiovascular disease (CVD) which may explain the 
increased risk of mortality from myocardial infarction (MI) and stroke for these 
patients,6, 8, 9 with mortality rates at five years ranging from approximately 30% to 
44%.10, 11 
The superficial femoral artery (SFA) is the most commonly diseased artery in the 
peripheral (lower limb) vasculature. Available therapies for patients with PAD 
remain controversial. Treatments include watchful waiting, medical management, 
endovascular treatment and surgical reconstruction.12 
Medical management comprises risk factor modification (i.e. diabetes control, smoking 
cessation, hyperlipidemia lowering), exercise therapy, pharmacological therapy.13, 14, 15 
Risk factor modification therapy is recommended to improve claudication and decrease the 
morbidity and mortality associated with the progression of PAD. Exercise therapy can 
produce clinical improvements in walking ability and reductions in claudication pain.19-21 
Pharmacological options include antiplatelet and anticoagulant therapies.16, 17, 18 
Surgery is typically reserved for subjects with CLI and is associated with risks such as 
wound complication, death, MI, infection and leg edema.18, 23 Patency rates for surgical 

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revascularization of the lower extremities have been reported to be 23-74%.18, 23, 24 
During the past decade, endovascular therapy has become the primary therapy in SFA 
interventions.25 
Multiple studies have been published reporting on the short and long-term results of 
percutaneous angioplasty interventions and/or stenting for PAD.26-46 Patency rates were 
reported to range between 29-93%.26-46 A meta-analysis of percutaneous angioplasty 
with provisional stenting compared to stenting alone for treatment of SFA lesions 
showed similar rates of target vessel revascularization, making both reasonable choices 
as endovascular treatments.47 
However, restenosis remains as a major limitation of the clinical usefulness of PTA 
and stenting. Poor long-term results, especially after the treatment of longer lesions in 
the femoropopliteal region, were reported.48-59 
The local application of anti-proliferative drugs (e.g., sirolimus, zotarolimus, 
everolimus, paclitaxel) for prevention of restenosis in coronary arteries via a stent 
delivery system has shown that these therapies successfully inhibit or reduce 
restenosis.60-74 The use of drug-eluting stents in the superficial femoral and proximal 
popliteal arteries had promising early results that have not been sustained over the long-
term. 
The SIROCCO I and SIROCCO II trials evaluated the local application of sirolimus for 
prevention of restenosis in the superficial femoral artery in 95 subjects comparing use of 
an uncoated nitinol stent to a drug-coated nitinol self-expanding stent. At 24 months 
there were no significant differences in ABI or in-stent restenosis as measured by peak 
systolic velocity ratio using duplex ultrasound. Both groups showed an improvement in 
Rutherford classification post procedure which was sustained over 24 months.75, 76 
Since the mid-2010s, drug-coated balloons (DCBs) have emerged as the first-line 
treatment option of obstructive SFA disease. These devices are essentially coated with 
paclitaxel. However, after promising results of several randomized controlled trials of 
paclitaxel-coated balloons (PCBs)77- 100, a meta-analysis of randomized controlled trials 
published in December 2018 by Katsanos et. al. identified an increased risk of late 
mortality at 2 years and beyond for patients treated with paclitaxel-coated devices 
compared to patients treated with uncoated devices102. Consequently, and further to its 
meta-analysis of long-term follow-up data from premarket trials, FDA made 
recommendations in August 2019 on the potential late mortality signal after treatment 
with paclitaxel-eluting devices in the femoropopliteal artery.101 In June 2020, the 
French Competent Authority, ANSM (Agence Nationale de Sécurité du Medicament et 
des Produits de Santé) 103, the German Authority BFARM (Bundesinstitut für 
Arzneimittel und Medizinprodukte) requested all manufacturers to add a warning and 
clinical summary related to the meta-analysis data to European IFUs.104 
In February 2021, the UK Competent Authority issued a similar statement recommending to 
not use paclitaxel drug-coated balloons (DCBs) or drug-eluting stents (DESs) in the routine 
treatment of patients with intermittent claudication, as the mortality risk generally 
outweighs the benefits.105  

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1.3. Study Rationale 
Whereas the concerning long-term outcomes of paclitaxel-coated PTA catheters have led to 
controversy in the interventional vascular community, CVT has developed an possible 
catheter-based treatment alternative by combining 1) a proven percutaneous transluminal 
angioplasty (PTA) balloon catheter designed to treat lesions within the peripheral 
vasculature with 2) a drug coating using a proven drug, everolimus, as the active 
pharmaceutical agent to benefit from the proven long history of safety and efficacy of the 
use of this drug for 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 used worldwide in drug-eluting stents (DES) and is considered the 
percutaneous treatment of choice for coronary artery disease (CAD).  The safety profile of 
everolimus-eluting stents is well established and safer than paclitaxel-eluting stents in long-
term clinical follow-ups2 . 
Use of everolimus, a drug with an excellent safety profile and a very long proven 
history for cardiovascular use, with a proven PTA catheter was demonstrated by CVT 
in series of pre-clinical evaluations in the swine model. Extensive bench and pre-
clinical studies have demonstrated that the CVT Everolimus-coated PTA Catheter is 
safe for its intended use with no adverse reactions associated to drug delivery for the 
treated vessel segment up to 30 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, is associated with the possibility of prevention of a 
restenostic reaction in the treated vessel, characterized by signs of drug effect in the 
histopathology studies at that time point in the animal model.  
The present trial will confirm the positive evaluations garnered to date in pre-clinical 
studies of the CVT Everolimus- coated PTA Catheter for its intended use of treating 
subjects with lesions in the SFA or popliteal (P1 segment) arteries. 
 
2. 
DESCRIPTION OF THE STUDY DEVICE 
The Chansu Vascular Technologies (CVT) Everolimus-coated PTA Catheter is an angioplasty 
 
 
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/s12872-016-0206-6 

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catheter designed to facilitate percutaneous treatment of subjects with documented symptomatic 
occlusion and/or >70% stenosis of the SFA or popliteal (P1 segment) artery. 
The CVT Everolimus-coated PTA Catheter is comprised of two main components: 
1) A CE-marked, commercially-available PTA balloon catheter (Ebony® 0.018” OTW PTA 
Balloon Catheter, Natec Medical Ltd. Reduit 72201, Mauritius) designed to treat 
peripheral vascular artery lesions.  The PTA catheters are also previously cleared by FDA 
for peripheral (PTA) angioplasty indications (FDA classification LIT, K143041).  
2) A drug coating comprised of an approved, commercially-available active pharmaceutical 
agent (API) mixed with an approved commercially-available excipient. The active 
pharmaceutical agent is the drug everolimus, in crystalline form, and it is applied onto the 
balloon using a glycerol ester excipient. Everolimus, like sirolimus, is an mTOR inhibitor 
drug with cytostatic properties. Everolimus is currently used in CE mark and FDA 
approved coronary drug-eluting stents [Promus (Boston Scientific), Xience (Abbott 
Vascular), Synergy (Boston Scientific)].   
2.1. Basic Catheter Specifications 
x Guidewire: 0.018”  
x Sheath Compatibility: 6 French or greater 
x Shaft length: 120 cm  
The product size offerings and total dose content for the CVT Everolimus-coated PTA 
Catheter are listed in Table 1. The available sizes are 4.0, 5.0 and 6.0mm diameters and 
balloon lengths 40, 80 and 120mm.  The nominal drug dose on all sizes is 3.0 μg/mm2. 
Table 1. CVT  Everolimus-coated PTA Catheter Size Matrix and Total Drug 
Content 
Balloon Diameter 
(mm) 
Balloon Length (mm) and 
Total Drug Content (μg) 
40 
80 
120 
4.0 
1508 
3016 
4524 
5.0 
1885 
3770 
5655 
6.0 
2262 
4524 
6786 
 
 
2.2. Indication 
The CVT Everolimus-coated PTA Catheter is intended for the treatment of patients with de-
novo or post-PTA occluded/stenotic or re-occluded/ restenotic lesions (excluding in-stent 
lesions) ≤150mm in length in femoropopliteal arteries with reference vessel diameters of 4-
6mm to establish blood flow and to maintain vessel patency. 
For additional information, refer to the Instructions for Use provided as Appendix E. 
 
 

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3. 
STUDY DESIGN 
The CVT-SFA Trial investigates the inhibition of restenosis using the CVT Everolimus-
coated PTA Catheter in the treatment of de-novo occluded/ stenotic or re-occluded/ 
restenotic superficial femoral or popliteal arteries. 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/clinic visit will occur at 6 and 12 months 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.  
 
Pre-Procedure 
Screening: Inclusion/Exclusion Criteria, Subject Signing of Informed Consent 
 
Procedure and Enrollment 
Treatment with CVT Everolimus-Coated PTA 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-SFA Study Participation Flow Chart 
3.1. Primary Endpoints 
Primary Safety Endpoint 
The primary safety endpoint for the study is freedom of major adverse event 
(MAE) rate at 6 months post-procedure, defined as a composite rate of 
cardiovascular death, index limb amputation and ischemia-driven target lesion 
revascularization (TLR). 

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Primary Effectiveness Endpoint 
The primary effectiveness endpoint for the study is patency at 6 months post-
procedure, defined as freedom from restenosis as determined by duplex 
ultrasonography (DUS) (peak systolic velocity ratio (PSVR) ≤ 2.4 or restenosis ≤ 
50%) within 6 months and freedom from ischemia-driven target lesion 
revascularization (TLR). 
Restenosis is determined by either PSVR >2.4, as assessed by an independent DUS core 
laboratory, or >50% stenosis, as assessed by an independent angiographic core laboratory in 
the event an angiogram has been recorded.  
3.2. Secondary Endpoints 
The following endpoints will be also evaluated as secondary endpoints: 
• 
Rate of Major Adverse Event (MAE) Rate in hospital and at 30 days, 1, 2 and 3 
years post-procedure, defined as a composite rate of cardiovascular death, index 
limb amputation and ischemia-driven Target Lesion Revascularization (TLR). 
• 
Rate of occurrence of arterial thrombosis of the treated segment. 
• 
Rate of ipsilateral embolic events of the study limb. 
• 
Rate of clinically-driven target lesion revascularization at 6, 12, 24 and 36 months. 
• 
Patency rate at 12 months post-procedure, defined as freedom from clinically 
driven TLR and duplex ultrasonography restenosis (ultrasound peak systolic 
velocity ratio ≤ 2.4 or stenosis ≤50%) 
• 
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 <50% (by QA), 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 <50% (by QA), using the CVT Everolimus-coated PTA 
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 procedure. 
• 
Ankle-Brachial Index (ABI) changes before procedure compared with ABI at 
discharge and at 6 and 12 months. 

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• 
Change in WIQ (walking impairment questionnaire) from pre-intervention at 6 and 
12-months follow-up. 
• 
Change in walking distance from pre-procedure at 6 and 12 months. 
• 
Change in Rutherford classification grades of chronic limb ischemia from pre-
intervention at 6 and 12-months follow-up for the treated limb. 
3.3. Study Population 
Subjects included in this study will be comprised of male and female subjects derived 
from the general interventional radiology or angiology population.  The study will 
include seventy-five (75) subjects with a superficial femoral and/or popliteal (P1 
segment) artery target lesion(s) eligible to be treated by interventional therapy and who 
meet all the inclusion criteria and none of the exclusion criteria of this study.  
3.4. 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. 
3.5. 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 and examinations. 
4. Subjects with symptomatic leg ischemia, requiring treatment of SFA or popliteal (P1 
segment) artery. 
5. De novo or restenotic lesion(s) >70% within the SFA and popliteal arteries in a 
single limb which are ≥3 cm and ≤15 cm in cumulative total length (by visual 
estimation).  Lesion must be at least 2 cm from any stented area. 
6. Subject is willing to provide informed consent and comply with the required follow 
up visits, testing schedule and medication regimen. 
7. Successful wire crossing of lesion. 
8. Target vessel reference diameter ≥4 mm and ≤6 mm (by visual estimation). 
9. Target lesion(s) can be treated with a maximum of two (2) CVT Everolimus-coated 
PTA Catheters. 
10. At least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by 
baseline angiography or prior MR angiography or CT angiography. 

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11. Life expectancy >1 year 
12. Rutherford classification of 2, 3 or 4 
3.6. Subject Exclusion Criteria 
Subjects with any of the following criteria should be excluded: 
1. Pregnant or lactating females. 
2. Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac 
or popliteal arteries. 
3. Significant gastrointestinal bleeding or any coagulopathy that would 
contraindicate the use of anti-platelet therapy. 
4. Known intolerance to study medications, everolimus or contrast agents. 
5. Doubts in the willingness or capability of the subject to allow follow-up 
examinations. 
 Subject is actively participating in another investigational device or drug study.
7. History of hemorrhagic stroke within 3 months prior to treatment 
8. Previous or planned surgical or interventional procedure within 30 days of index 
procedure. 
9. Prior vascular surgery of the target lesion. 
10. Lesion length is <3 cm or >15 cm or there is no normal proximal arterial 
segment in which duplex ultrasound velocity ratios can be measured. 
11. Known inadequate distal outflow. 
12. Significant inflow disease. 
13. Acute or sub-acute thrombus in target vessel. 
14. Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting 
balloons, brachytherapy, lithotripsy). 
15. Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) 
with significant lesions (≥ 50% stenosis) may not be treated during the same 
procedure. 
16. Treatment of the contralateral limb during the same procedure or within 30 days of 
the study procedure. 
17. Rutherford classification of 0, 1, 5 or 6. 
18. Presence of prohibitive calcification that precludes adequate PTA treatment. 
 Subjects held in custody in an institution by official or court order.
3.7. Subject Enrollment Point 
All subjects who are candidates for endovascular treatment of the SFA or popliteal 
artery will undergo screening for study eligibility and, if applicable, for study 

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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 have been met.
x Successful treatment of the inflow (iliac) artery without complication, if applicable.
x Target lesion is successfully crossed by a guidewire.
x CVT Everolimus-coated PTA Catheter has entered the vasculature.
3.8. Subject Discontinuation 
Every subject should remain in the study 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 record. 
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.
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 that 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”. 

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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. 
3.9. Early Termination of the Clinical Study 
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.  Per definition, this would 
be the case in the event that the Major Adverse Event (MAE) rate reaches a level greater 
that the upper limit of the 95% confidence interval of the anticipated MAE.  MAE is 
defined as a composite rate of cardiovascular death, index limb amputation and ischemia-
driven target lesion revascularization (TLR). 
Notification of study suspension or termination will occur no later than five (5) working 
days after the 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 2 for a summary of pre-procedure, 
procedure, discharge and follow up activities. 
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 

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medications and protocol-required medications. 
Clinical Assessments 
The dorsalis pedis and posterior tibial pulses for the treated limb should be documented. 
The distal ipsilateral extremity should be examined to ensure no gangrene or ischemic 
ulcers are present. 
Hemodynamic Evaluation 
Ankle brachial index (ABI) measurement will be obtained for the target limb. 
Functional Status 
Functional status using the Rutherford Becker Clinical Categories will be determined for the 
target limb. 
Subject-perceived walking performance will be evaluated utilizing a walking impairment 
questionnaire (WIQ). 
Walking distance will be evaluated using either the Walking Test or the Treadmill Test. 
Claudication at rest and after walking will be noted. 
Laboratory Assessments 
A pregnancy test should be administered to all female subjects of childbearing potential 
within 14 days of the procedure. 
The following laboratory tests should be obtained for all subjects within 7 days of the index 
procedure. 
x Hemoglobin 
x Hematocrit 
x White Blood Cell Count 
x Absolute Platelet Count 
x Serum Creatinine 
x Coagulation tests as per standard of care of the hospital (e.g., Prothrombin Time 
(PT) and activated Prothrombin Time (aPTT). 
Duplex Ultrasonography Assessment (Optional) 
At the discretion of the investigator, duplex ultrasonography may be performed 
according to the ultrasound core laboratory guidelines. 
4.2. Concomitant Medical Therapy 
Prior to the study procedure, it is required that subjects receive aspirin (ASA) and either 
clopidogrel or ticlopidine (only if subject has known allergy to clopidogrel or prasugrel) per 
hospital standard of care (either antiplatelet medication 3 days pre-procedure or loading 
dose on the day of intervention). Recommended aspirin dose is 100 mg daily; for 
clopidogrel the recommended dose is 75 mg daily and for ticlopidine 250 mg twice a day. 

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4.3. SFA PTA Procedure 
Procedural Medications 
During the procedure, 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. 
Baseline Angiography 
The diagnostic and interventional procedure can be conducted via either contralateral or 
antegrade approach at the investigator’s discretion. A pelvic angiogram (digital subtraction 
angiography, Magnetic Resonance (MR) angiography, or Computed Tomography (CT) 
angiography) with run-off must have been performed prior to the PTA procedure (run-off 
should include popliteal and distal vessels) to confirm patent inflow and outflow as well as 
run-off required within the inclusion criteria.  
Treatment Strategy 
This study allows for treatment of de novo occluded/stenotic or re-occluded/restenotic 
superficial femoral (SFA) or popliteal artery (P1 segment) lesions in a single limb that are 
≥3 cm (30 mm) and ≤15 cm (150 mm) in cumulative length, with up to two (2) CVT 
Everolimus-coated PTA Catheters. The lesion(s) should be within 1 cm distal to the femoral 
bifurcation in the SFA and 3 cm from the proximal margin of the intercondylar fossa. 
The timing and method of treatment of any contralateral non-target lesion(s) is at the 
discretion of the investigator; however, it should be >30 days before or after the study 
procedure.  A contralateral non-target lesion(s) cannot be treated during the same procedure 
in order to avoid complications. 
Subjects selected for treatment must have a patent inflow artery and outflow arteries free 
from significant lesions (≥50% stenosis) as confirmed by angiography. If the ipsilateral iliac 
artery is diseased, but not occluded, it may be treated prior to the treatment of the target 
SFA/popliteal lesion. Successful treatment of the inflow artery is defined as attainment of 
final residual diameter stenosis of <30% without residual dissection or complication during 
the treatment. Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal 
arteries) with significant lesions (≥50% stenosis) may not be treated during the same 
procedure. 
Pre-dilatation will be performed for all target lesions with a non-study balloon catheter. 
After pre-dilatation, the investigator will determine the suitability of the lesion for treatment 
by PTA alone. 
The target lesion should be treated after meeting the general and angiographic inclusion and 
exclusion criteria. Additional treatment modalities, including but not limited to, rotational or 
directional atherectomy, cryoplasty, scoring/cutting balloons, laser, brachytherapy or 
lithotripsy must not be performed in conjunction with this procedure. 
The balloons should be sized to ensure the full length of the lesion is treated and that the 
balloon, upon inflation, apposes the arterial wall without oversizing. 

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The initial inflation of the study device should be ≥ 1 minute. 
For a residual stenosis >50% or significant dissection after study treatment, post-dilatation 
should be performed. A commercially available non-drug eluting nitinol stent may be used 
to treat a flow-limiting dissection or persistent residual stenosis if balloon inflation is 
unsuccessful.  Post-dilatation of the stent, if required, should be done with the CVT 
Everolimus-coated PTA Catheter. 
PTA Procedure 
The appropriate balloon size will be selected after review of the subject’s baseline 
angiogram and determination of the reference vessel diameter and lesion length. 
Pre-dilatation will be performed on all subjects per the following sequence: after crossing of 
the target lesion with a guidewire, pre-dilatation will be performed with a non-study balloon 
catheter.  Based on the suitability of the lesion, the investigator will determine if the lesion 
can be treated by PTA alone or if treatment with a stent is required (e.g. dissection, stenosis 
>50%).  If a stent is required, the investigator will implant the stent  and the patient cannot 
be included in the study (e.g. screen fail). If the lesion is suitable for PTA treatment alone, 
the CVT Everolimus- coated PTA Catheter will be used to treat the lesion. 
All catheters, including the CVT Everolimus-coated PTA Catheter, should be delivered and 
deployed per their respective Instructions for Use (reference Appendix E for CVT 
Everolimus-coated PTA Catheter IFU). All balloon inflations and stent deployments, when 
applicable, should be captured per the angiographic core laboratory guidelines. 
Criteria for Bail-Out or Alternative Procedures 
For a post-treatment residual stenosis >50% or significant dissection after study treatment, 
post-dilatation should be performed. A commercially available nitinol stent may be used to 
treat a flow-limiting dissection or persistent residual stenosis >50% only after post-
dilatation inflation is unsuccessful.  If stent post-dilatation is performed, a CVT Everolimus-
coated PTA Catheter should be used. 
Angiography following PTA 
Angiographic imaging is to be performed according to the angiographic core laboratory 
protocol and will include runoff into the distal extremity. Post-procedural images should be 
captured in a precise manner such as was used for the pre-procedure images. 
 
4.4. Post-Procedure Subject Management 
Following the treatment procedure, the subject will be treated in accordance with the 
hospital standard of care for PTA interventions. 
Sheath Removal and Ambulation 
Use of approved vascular closure devices are allowed, provided the device is used 
according to the manufacturer’s instructions for use 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 

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The optimal duration of antiplatelet therapy for each subject is to be determined by the 
investigator. 
All subjects enrolled into the trial are recommended to be maintained on 75 mg of 
clopidogrel bisulfate daily for a minimum of one (1) month following the angioplasty 
procedure, increased to three (3) months if a stent was used.  All subjects will receive ≥ 100 
mg of aspirin daily to be taken throughout the length of the study following the procedure.  
(for minimum of 12 months following 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. 
Clinical Assessments 
The dorsalis pedis and posterior tibial pulses for the treated limb should be documented.  
The distal ipsilateral extremity should be examined to ensure be examined to ensure no 
gangrene or ischemic ulcers are present. 
Laboratory Tests 
If the subject presents with less than desired clinical outcome or symptoms of an adverse 
event laboratory tests should be obtained within 12-24 hours post procedure (or prior to 
hospital discharge). Should laboratory tests be required, the following tests are 
recommended: 
x Hemoglobin 
x Hematocrit 
x White Blood Cell Count and differential 
x Absolute Platelet Count 
x Blood Urea Nitrogen 
x Serum Creatinine 
x Serum Glutamic-Pyruvic Transaminase (SGPT) 
x Serum Glutamic-Oxaloacetic Transaminase (SGOT) 
x Coagulation tests as per standard of care of the hospital (e.g., Prothrombin Time 
(PT) and activated Prothrombin Time (aPTT) 
Hemodynamic Evaluation 

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An ankle brachial index (ABI) measurement will be obtained for the treated limb. 
Duplex Ultrasonography Assessment/Rutherford Classification 
Duplex ultrasound examination and Rutherford classification will be performed prior to 
hospital discharge of the treated limb in accordance with the ultrasound core laboratory 
requirements. 
Adverse Events 
Documentation of adverse events. 
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 and medications. Alternatively, this contact can be performed in a site 
visit. 
Subject Clinical Visit at 6 months (180 ±30 days) 
x Assessment of ischemia 
x Claudication at rest and after walking 
x Completion of the walking impairment questionnaire (WIQ) 
x Completion of either the Walking Test or Treadmill Test 
x Rutherford Classification 
x Ankle Brachial Index (ABI) measured at rest. 
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 Concomitant medication (name, dose, duration) 
x Duplex ultrasonography examination per core laboratory guidelines 
x Adverse event assessment 
x Medications 
Subject Clinical Visit at 12 months (365 ±30 days) 
x Assessment of ischemia 
x Claudication at rest and after walking 
x Completion of the walking impairment questionnaire (WIQ) 
x Completion of either the Walking Test or Treadmill Test 
x Rutherford Classification 

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x Ankle Brachial Index (ABI), measured at rest 
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 Concomitant medication (name, dose, duration) 
x Duplex ultrasonography examination 
x Adverse event assessment 
x Medications 
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 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 and medications. Alternatively, this contact can be 
performed in clinical visit with the referring physician. 
 
 

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Table 2. CVT-SFA Study Pre-Procedure, Procedural, Discharge and Follow Up Activities 
 
 
 
PROCEDURE/TEST 
Prior to Procedure 
(Within 14 days) 
Pre-Procedure 
(Within 24 hours) 
PROCEDURE 
Pre-Discharge 
30 days (r7 days) 
Phone call or 
Office\hospital Visit 
180 days (r30 days) 
Office/hospital visit 
365 days (r30 days) 
Office /hospital visit 
24 and 36 months 
(r30 days) 
Patient Medical/Clinical 
History 
9
Chronic Concomitant 
Medications 
9
9
9
9 9 9
Patient Informed Consent 
9
General/Inclusion 
Exclusion 
9
Angiographic/Anatomic 
Inclusion/Exclusion Criteria 
 
9
Pregnancy Test (if 
applicable) 
9
Serum Hematology 
9
9* 
Blood Chemistry 
9
9* 
Peripheral Angiogram with 
Runoff 
 
99

Duplex Ultrasonography 
Examination 
9# 
9
9
9

Ankle Brachial Indices 
9
9
9
9

Rutherford-Becker 
Classification 
9
9
9
9

WIQ 
9
9
9

Walking Test or Treadmill Test 
9 

 
 
9 
9 
Per-protocol Medications 
 
999
Adverse Events 
 
99
9
9 9 9
 
#   optional 
*   If the subject presents with less than desired clinical outcome or symptoms of an adverse event  
 
 

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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 persons, 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., MAE) occur between study evaluation visits. 
Adverse event reporting begins when the index procedure is completed. 
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 which 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 PTA procedure.  
x Abrupt closure  
x Acute MI  
x Allergic reaction to contrast, concomitant medications (Allergic Reaction) 
x Amputation  
x Aneurysm  
x Arrhythmias (bradycardia & tachycardia)  
x Arterial dissection  
x Arterial perforation or rupture  
x Artery spasm  
x AV fistula 
x Bleeding  

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x Bypass graft surgery (emergent or non-emergent)  
x Chest pain  
x Death (cardiovascular or non-cardiovascular related) 
x Discomfort during the procedure  
x Embolism/PTA catheter embolism  
x Endocarditis 
x Fever  
x Groin Bruising/Discomfort 
x Hematoma  
x Hemorrhage 
x Hypertension  
x Hypotension  
x Injury to the groin blood vessel  
x Infection or pain at insertion site  
x Ischemia  
x Nausea  
x Pseudoaneurysm  
x Renal failure  
x Restenosis  
x Sepsis /infection 
x Stroke/CVA  
x Wound complication or wound infection  
x Thrombosis  
x Total occlusion  
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 PTA catheter: 
x Abdominal pain  
x Anemia 
x Angioedema 
x Anorexia 
x Asthenia 
x Constipation 

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x Cough 
x Delayed wound healing/fluid accumulation 
x Diarrhea 
x Dyslipidemia (including hyperlipidemia and hypercholesterolemia) 
x Dyspnea 
x Dysgeusia 
x Dyspepsia 
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 

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x Thrombocytopenia 
x Thrombotic microangiopathy  
x Thrombotic thrombocytopenic purpura 
x Tremor 
x Urinary tract infection 
x Upper respiratory tract infection 
x Vomiting 
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: 
 
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. 

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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 temporal sequence is relevant and the event abates upon device 
application completion/removal, or reappearance of the event on 
repeat device application (re-challenge). 
 
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 
activation/exposure) impact on the serious adverse event 
(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. 
 
 
 

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5.5. Serious Adverse Events 
An Adverse Event is considered serious if the event 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 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 

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the new reportable event or of new information in relation with an already report 
event. 
Reporting by the Clinical Trial Investigator to the 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 10.4), 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, 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 pre-determined Objective Performance Criteria (OPC). 
The OPCs for the primary safety and effectiveness endpoints have been determined using 
historical control data from published studies. Since this is a feasibility trial, the attainment 
of statistical significance is neither a necessary nor a sufficient condition for determining 
whether the device merits further study. For example, if the data exhibits a trend (p≤ 0.15) 
toward statistical significance when compared to historical control and raises no safety 
concerns, it may be deemed worthy of further investigation. In addition, there will be a 
focus on estimating the magnitude of observed rates at 180 days post-procedure and the 
associated 95% confidence 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 study 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 procedure and at least one valid follow-up 
visit.  

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6.3. Sample Size Justification 
Approximately seventy-five (75) subjects at up to eight (8) active sites will be enrolled in 
the CVT-SFA Trial. All subjects will be scheduled for clinical examination and duplex 
ultrasonography assessment at six (6) months. The objective of the study is to assess the 
initial feasibility and performance of the CVT Everolimus-coated Catheter in the 
treatment of subjects with de-novo occluded/stenotic or re- occluded/restenotic 
superficial femoral (SFA) or popliteal arteries. The study is powered based on primary 
safety and effectiveness endpoints. 
The primary safety endpoint for this analysis is freedom from Major Adverse Event 
(ffMAE, %) at six (6) months post-procedure. The null (H0) and alternative (HA) hypotheses 
are: 
H0:  ffMAE historical control d ffMAE CVT treatment 
HA:  ffMAE historical control > ffMAE CVT treatment 
The proposed sample size of N=75 is based on the primary safety endpoint of 
freedom from MAE at 6 months. The sample size calculation is based on the 
following assumptions: 
x A single comparison of CVT Everolimus-coated PTA Catheter treatment group to a 
safety OPC. 
o The assumed difference between the OPC and the treatment group is 15%. 
This assumption is made based on the results observed in the control arm 
of the IN.PACT, STELLAREX, LUTONIX, RANGER programs3  
o One-tailed α=0.025 
The primary effectiveness endpoint for this analysis is patency (%) at six (6) months. The 
null (H0) and alternative (HA) hypotheses are: 
H0:  Patency historical control d Patency CVT treatment 
HA:  Patency historical control > Patency CVT treatment 
The sample size of N=75 is based on the primary effectiveness endpoint of patency 
(%) at six (6) months and the following assumptions: 
x 
A single comparison of CVT Everolimus-coated PTA Catheter treatment group to a 
patency OPC. 
o The assumed difference between the OPC and the treatment group is 
15%. This assumption is made based on the results observed in the 
control arms of the IN.PACT, STELLAREX, LUTONIX, RANGER 
programs3 
o Approximately 10% rate of lost to follow-up or dropout. 
 
 
3   IN.PACT https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140010c.pdf STELLAREX https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160049B.pdf, 
LUTONIX https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130024S009B.pdf RANGER https://www.accessdata.fda.gov/cdrh_docs/pdf19/P190019B.pdf  

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o One-tailed α=0.025 
The primary safety endpoint for this analysis is the freedom from Major Adverse Events 
at six (6) months. The study is powered based on this primary safety endpoint and the 
goal is to compare the CVT Everolimus-coated PTA Catheter treated group to an OPC 
established using a database of historical studies3. Since this is a feasibility trial, 
hypothesis testing and the attainment of statistical significance when compared to 
historical control are neither necessary nor sufficient conditions to determine whether 
the device merits further study. Instead, the focus will be on estimating the frequency of 
Major Adverse Events at six (6) months post-procedure and the associated 95% 
confidence interval. The sample size for the study based on the primary safety endpoint 
of frequency of Major Adverse Events at six (6) months was calculated using the 
following assumptions: 
x A single comparison of CVT Everolimus-coated PTA Catheter treatment group to 
an historical control group 
x An OPC of 70%  
Given the above assumptions, enrollment of 75 subjects (safety population) will be the 
recruitment goal. 
If 11 of 75 (15%) subjects experience MAEs, the point estimate for ffMAE is 85% and 
the 95% CI is [75.3%, 92.4%], well above the OPC of 70%. 
The primary effectiveness endpoint for this analysis is patency at six (6) months. The 
study is also powered on this endpoint and the goal is to compare the CVT Everolimus-
coated PTA Catheter treated group to an OPC established using the same database of 
historical studies as was used above for safety. The sample size for the effectiveness 
endpoint of patency at six (6) months post-procedure and the associated 95% confidence 
interval is estimated under the following assumptions: 
x A single comparison of CVT Treatment group to an historical control group 
x A patency OPC of 65%  
Given the above assumptions, enrollment of 75 subjects (yielding ~68 evaluable 
subjects) will be the recruitment goal. 
If as few as 55 of 68 subjects remain patent at 6 months, the point estimate is 81% and 
the 95% CI is [71.5%, 90.2%], well above the OPC of 65%. 
The power estimates from enrolling 75 subjects to detect 15%-point margins above 
the Safety and Effectiveness OPCs are 85% and 78%, respectively. 
Sample size and power calculations were performed using PASS13.  
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. Any unused or spurious data will be noted as 

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appropriate in the final report. 
Analysis of Primary Endpoints 
The primary effectiveness endpoint of patency at six (6) months will be analyzed on a 
per-subject basis for the evaluable populations.  
The primary safety endpoint of freedom from MAE at 6 months will be analyzed using 
the safety population.  
For both primary endpoints (ffMAE and patency at 6 months), percentages and exact 
95% confidence intervals using Clopper-Pearson’s method will be calculated.  
Analysis of Secondary Endpoints 
All secondary endpoints will be analyzed for the per-treatment evaluable 
population descriptive statistics will be provided to gain better understanding 
of the data. 
For binary variables such as MAE or 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 summary statistics will be presented instead. 
For time-to-event variables, such as time to target lesion revascularization, survival 
curves will be constructed using Kaplan-Meier estimates, and log rank test results will 
be displayed for descriptive purposes only. 
 
 
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 Peripheral Catheterization, Stenting and PTA 
It is expected that risks associated with this study will be not significantly different than 
those with standard interventional procedures for PAD disease in the superficial or 
popliteal (P1 segment) arteries. The list of adverse events that may result from 
peripheral intervention includes but is not limited to: abrupt closure, acute myocardial 
infarction, allergic reaction to contrast, amputation, aneurysm, arrhythmias, arterial 
dissection/perforation/rupture, artery spasm, AV fistula, bleeding, bypass graft surgery, 
chest pain, death, discomfort during procedure, embolism (air, tissue, thrombosis, 
device), endocarditis, fever, groin bruising/discomfort, hematoma, hemorrhage, 
hypertension, hypotension, injury to groin vessel, infection or pain at insertion site, 
ischemia, nausea, pseudoaneurysm, renal failure, restenosis, sepsis/infection, 
stroke/CVA, wound complication/infection, total occlusion, vomiting/nausea. 
7.2. Potential Risks from Everolimus Coating 

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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 oncology4,5. 
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, pruritus, pyrexia, rash, 
stomatitis, thrombocytopenia, thrombotic microangiography, thrombotic thrombocytopenic 
purpura, tremor, urinary tract infection, upper respiratory tract infection and vomiting6.  
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 PTA 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. 
 
 
4 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 
5 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). 
 
6 Certican® (Everolimus) Product Insert. Novartis, Mar 2013.  

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Based on current information available to date on everolimus as a drug entity and on the 
CVT Everolimus-coated PTA Catheter evaluated in preclinical studies, it is unlikely, with 
the total dosage on the CVT Everolimus-coated PTA 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-SFA Trial will be conducted by skilled and trained investigators relative 
to interventional procedures and this protocol. 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 accordance with standard of care requirements for peripheral 
interventional procedures. 
7.4. Potential Benefits 
Given that paclitaxel, the drug used on most drug-coated balloons (DCBs) that have 
been a first-line treatment option of obstructive SFA disease since the mid-2010s, has 
a potentially increasing risk of late mortality at 2 years and beyond compared to 
patients treated with uncoated devices, 101 the replacement of paclitaxel with 
everolimus, a drug with a proven safety profile in drug-eluting stents (DES) and 
considered as the percutaneous treatment of choice for coronary artery disease (CAD), 
may be the alternative to reduce restenosis and late lumen loss in the superficial 
femoral and proximal popliteal arteries.  
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. 
8.2. 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 
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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 or regional 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 investigator’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. The Sponsor will make final determination of approved 
investigators. 
x Signed investigator’s agreement 
x Completed site specific in-servicing and 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 
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 

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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 treatment procedure: 
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 subjects’ questions. Subjects will be 
assured that they may withdraw from the study 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 
consent from sponsor. 
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 

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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 3.  
CVT-SFA 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 
 
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. 
General Duties 
It is the sponsor’s responsibility to ensure that the study is conducted according to Good 
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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.  
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. 
Training of Investigator/Site Personnel and Periodic 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. 
10.2. Investigator's Brochure 
The sponsor will prepare, assemble and maintain all pre-clinical and available clinical 
data and documentation and will summarize this information in the clinical 
investigator's brochure. 
10.3. 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 
10.4. 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 CEC 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 CEC will establish explicit rules outlining the minimum 
amount of data required and the algorithm to be followed in order to classify a clinical 
event. All members of the CEC will be blinded to the primary results of the trial. 
The CEC 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. 

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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 the 
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 (LBL1116) 
x 
Appendix D 
Declaration of Helsinki 
x 
Appendix E 
Instructions for Use (LBL1117) 
x 
Appendix F 
Schedule of Events 
x 
Appendix G 
Research Agreement Template (FRM1118) 
x 
Appendix H 
Investigators Responsibilities 
x 
Appendix I 
Duplex Ultrasonography Core Lab Guidelines 
x 
Appendix J 
Risk Analysis 
x 
Appendix K 
General Safety and Performance Requirements Statement  
x 
Appendix L 
Case Report Forms (FRM1119) 
x 
Appendix M Angiography Core Lab Guidelines 
 
 

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97. Albrecht T, Waliszewski M, Roca C, et al. Two-Year Clinical Outcomes of the CONSEQUENT 
Trial: Can Femoropopliteal Lesions be Treated with Sustainable Clinical Results that are 
Economically Sound?. Cardiovasc Intervent Radiol. 2018;41(7):1008-1014. doi:10.1007/s00270-
018-1940-1 
98. Bausback Y, Willfort-Ehringer A, Sievert H, et al. Six-Month Results From the Initial Randomized 
Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment. J Endovasc Ther. 
2017;24(4):459-467. doi:10.1177/1526602817710770 
99. Steiner S, Willfort-Ehringer A, Sievert H, et al. 12-Month Results From the First-in-Human 
Randomized Study of the Ranger Paclitaxel-Coated Balloon for Femoropopliteal Treatment. JACC 
Cardiovasc Interv. 2018;11(10):934-941. doi:10.1016/j.jcin.2018.01.276 
100. Rosenfield K, Jaff MR, White CJ, et al., on behalf of the LEVANT 2 Investigators. Trial of a 

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Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. N Engl J Med 2015;373:145-53. 
101. The Food and Drug Administration Update: Treatment of peripheral arterial disease with 
paclitaxel-coated balloons and paclitaxel-eluting stents potentially associated with increased 
mortality. August 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. 
102. 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. 
103. 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 
104. 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 
105. 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 
Trial Abbreviations 
 
ABI  
Ankle-Brachial Index  
ABR  
Angiographic Binary Restenosis  
AE  
Adverse Event  
aPTT  
Partial Thromboplastin Time  
AV  
Arteriovenous  
BMI  
Body Mass Index  
CBC  
Complete Blood Count  
CEC  
Clinical Events Committee  
CI  
Clinically Indicated  
CLI  
Critical Limb Ischemia  
COPD  
Chronic Obstructive Pulmonary Disease  
CRF  
Case Report Form  
CT  
Computed Tomography  
CVA  
Cerebrovascular Accident  
CVD  
Cardiovascular Disease  
CVT 
Chansu Vascular Technologies 
EC  
Ethics Committee  
GCP  
Good Clinical Practice  
ICH  
International Conference on Harmonisation  
ID  
Identification  
IFU  
Instructions for Use  
ISO  
International Organization for Standardization  
ITT  
Intent-to-Treat  
LLL  
Late Lumen Loss  
MAE  
Major Adverse Event  
MEC  
Medical Ethics Committee  
MI  
Myocardial Infarction  
MLD  
Minimum Lumen Diameter  
MR  
Magnetic Resonance  
PAD  
Peripheral Artery Disease  
PT  
Prothrombin Time  
PTA  
Percutaneous Transluminal Angioplasty  
QA  
Quantitative Angiography  
RVD  
Reference Vessel Diameter  
SAE  
Serious Adverse Event  
SC  
Steering Committee  
SFA  
Superficial Femoral Artery  
SGOT  
Serum Glutamic-oxaloacetic Transaminase  
SGPT  
Serum Glutamic Pyruvic Transaminase  
TER  
Target Extremity Revascularization  
TLR  
Target Lesion Revascularization  
WIQ  
Walking Impairment Questionnaire  

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Trial Definitions  
Abrupt or Acute Closure 
 
Quantitative Angiography findings or obstruction of contrast flow in the dilated segment where 
there had previously been a patent segment and documented anterograde flow. For an initial 
subtotal lesion, acute closure describes a total obstruction to arterial flow, either sustained or 
transient at the site of the treated lesion. In a situation where the dilated segment was closed or 
occluded at the beginning of the procedure, acute closure should only be used to describe the 
outcome if there was a period of vessel patency during the procedure documented by normal 
anterograde contrast flow beyond the lesion site with the PTA catheter removed from the vessel 
followed by closure before the patient was discharged from the catheterization laboratory. 
Acute Success 
 
Acute success is classified according to the following definitions: 
Clinical Success 
 
Clinical success (per subject) is defined as technical success without the occurrence of 
major adverse events during procedure. 
Lesion Success 
 
Lesion success is defined as achievement of a final in-lesion residual diameter stenosis of 
<50% (by Quantitative Angiography), 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 
 
Technical success is defined as achievement of a final in-lesion residual diameter stenosis 
of < 50% (by Quantitative Angiography), using the CVT Everolimus-coated Percutaneous 
Transluminal Angioplasty Balloon Catheter without a device malfunction after wire 
passage through the lesion. Pre and post-dilatation of the lesion are considered part of 
assigned device treatment. 
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. 
Amputation 
 
The removal of a body extremity by surgery. For this study, the definition of amputation will only 
apply to amputations of the limb that was treated. 
 
A minor amputation will be defined as below the ankle; and a major amputation will be defined 
above the ankle. 
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. 
 

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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. 
Ankle Brachial Index (ABI) 
 
The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood 
pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms. 
 
An ABI of 0.9 – 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral 
artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 
indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification 
of the walls of the arteries and non-compressible vessels, reflecting severe peripheral vascular 
disease. Patients with ABI values greater than 1.3 will be excluded from the analysis. 
 
Calculation of the Ankle Brachial Index: 
  
(Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI) 
Improvement of Ankle Brachial Index: 
Patients will be considered as having an improvement in ABI if their baseline value was 
less than 0.9 and either increased by more than 0.10, or the follow-up ABI value is in the 
normal range (0.9-1.3). 
Worsening of Ankle Brachial Index: 

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Deterioration in the Ankle Brachial Index (ABI) by more than 0.15 from the maximum 
early post-procedural level. 
Arterial Flow 
 
During and following deployment, each vessel will be evaluated and graded, according to the 
following arterial flow parameters. These findings will be recorded and included in the study 
records. 
Flow 0: No antegrade flow beyond the point of occlusion or target site. 
Flow 1: Contrast passes the point of obstruction but “hangs up” and fails to opacify the entire 
distal vasculature during the duration of the cine-angiographic filming sequence. 
Flow 2: Antegrade filling of contrast with complete filling of the artery and its major and minor 
branches, but with visually determined decreased rate of flow compared to flow rate 
observed during pretreatment angiogram. Alternatively, delayed contrast washout in the 
target site territory may occur. 
Flow 3: Antegrade flow of contrast with complete filling of the artery and its major and minor 
branches with visually determined flow rate from equal to the flow rate observed during 
pretreatment angiogram. 
Arterial Inflow 
 
For a lesion in the superficial femoral artery (femoro-popliteal level) inflow refers to the aorto-iliac 
level. Good inflow implies that vessels proximal to a target treatment site are free of 
hemodynamically significant lesions (≥ 50%). 
Arterial Outflow 
 
For a lesion in the superficial femoral artery (femoro-popliteal level) outflow refers to combined 
levels distal to the lesion, including the following arteries: distal popliteal, tibioperoneal trunk, 
anterior tibial, posterior tibial, peroneal, dorsalis pedis, plantar and pedal. Good outflow implies 
that the distal popliteal, tibioperoneal trunk and at least one of the infrapopliteal arteries (anterior 
tibial, posterior tibial, peroneal) is free of hemodynamically significant lesions (≥ 50%) and that 
there is in-line flow into the foot. 
Binary Restenosis 
 
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). 

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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: 
 
Any death due to proximate cardiac cause (eg, myocardial infarction (MI), low-output failure, fatal 
arrhythmia), unwitnessed death, or death of unknown cause. 
Vascular Death: 
 
Death caused by non-coronary vascular causes, such as cerebrovascular disease, pulmonary 
embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases. 
Non-cardiovascular Death: 
 
Any death not covered by the above definitions, such as death caused by infection, malignancy, 
sepsis, pulmonary causes, accident, suicide, or trauma. 
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. 
Enrollment 
 
The patient will be considered enrolled into the study upon the completion of all the following: 
• 
A signed patient informed consent, 
• 
General and angiographic criteria for enrollment has been met 
• 
Successful treatment of the inflow (iliac) artery without complication, if applicable 
• 
Target lesion is successfully crossed by the guidewire 

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• 
The study device has entered the patient’s vasculature 
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, who is responsible for the overall conduct of the trial at 
all sites. 
Major Adverse Event (MAE) 
A composite rate of cardiovascular death, index limb amputation and ischemia-driven Target 
Lesion Revascularization (TLR). 
Minimum Lumen Diameter (MLD) 
 
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. 
Multilevel Disease 
 
Presence of obstructive lesions at more than one level in the same extremity as the treatment 
lesion. 
Myocardial Infarction (MI) 
 
Q-wave MI (QMI) - Development of new pathological Q-waves in 2 or more contiguous leads 
(according to the Minnesota code) with or without post-procedure creatine kinase (CK) or CK-MB 
levels elevated above normal. 
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. 
Patency Rate 
 
Patency rate defined as freedom from clinically-driven TLR and from Duplex ultrasound or 
angiographic stenosis >50% at 6, 12, and 24 months. 
Percent Diameter Stenosis 

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The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views 
(when possible) by QA. 
Popliteal Artery 
 
Defined as the vessel located between Hunter’s canal and the trifurcation of the anterior tibial, 
posterior tibial and peroneal arteries. 
Primary Investigator 
 
A physician responsible for conducting the clinical trial at each investigational site, which is 
responsible for the overall conduct of the trial at their site and compliance with protocol. 
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. 
Rutherford/Becker Categories - Chronic Limb Ischemia 
Category 
Clinical Description  
Objective Criteria  
0 
Asymptomatic, no hemodynamically 
significant occlusive disease  
Normal results of treadmill*/stress test  
1 
Mild claudication  
Treadmill* exercise complete, post exercise 
AP is greater than 50 mm Hg but more than 25 
mm Hg less than normal  
2 
Moderate claudication  
Symptoms between those of categories 1 and 3  
3 
Severe claudication  
Treadmill* exercise cannot be completed post 
exercise AP is less than 50 mm Hg  
4 
Ischemic rest pain  
Resting AP of 40 mm Hg or less, flat or barely 
pulsatile ankle or metatarsal plethysmographic 
tracing, toe pressure less than 30 mm Hg  
5 
Minor tissue loss, non-healing ulcer, 
or focal gangrene with diffuse pedal 
ischemia  
Resting AP of 60 mm Hg or less, flat or barely 
pulsatile ankle metatarsal plethysmographic 
tracing flat or barely pulsatile, toe pressure less 
than 40 mm Hg  
6 
Major tissue loss, extending above 
transmetatarsal level, functional foot 
no longer salvageable  
Same as category 5  
*5 minutes at 3.2 km/h on a 12° incline 
Worsening Rutherford Becker Clinical Category: 
A deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 
categories from the earliest post-procedural measurement or to a category 5 or 6. 

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Revascularization 
Target Lesion Revascularization (TLR): 
Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the 
target lesion or bypass surgery of the target vessel performed for restenosis or other complication 
of the target lesion. 
Clinically Indicated (CI) Target Lesion Revascularization: 
A revascularization of the target lesion is considered clinically-indicated if angiography shows a 
percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical 
Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an 
increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest 
post-procedural measurement or to a category 5 or 6.) An independent angiographic core 
laboratory should verify that the severity of percent diameter stenosis meets requirements for 
clinical indication and will overrule in cases where investigator reports are not in agreement. 
Target Extremity Revascularization (TER) 
Target extremity revascularization (TER) is defined as any percutaneous intervention or surgical 
bypass of any segment of the target extremity. The target extremity is defined as the ipsilateral 
limb arteries proximal and distal to the target lesion, which includes upstream and downstream 
branches and excludes the target lesion itself. 
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. 
Successful Pre-Dilatation 
Pre-dilatation has been successfully completed without complications if all of the following apply: 
• 
Diameter stenosis ≤ 70% (by visual estimate) 
• 
Lesion length still within the requirements of the protocol/CIP 
• 
No angiographic complications 
Superficial Femoral Artery (SFA) 

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The SFA connects to the popliteal artery at the opening of adductor magnus or hunter's canal 
towards the end of the femur. 
Thrombosis 
 
Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or 
angiography at the site of the treated lesion with or without symptoms. 
 
  
• Acute thrombosis: 0 - 24 hours post study procedure 
 
  
• Subacute thrombosis: > 24 hours - 30 days post study procedure 
 
  
• Late thrombosis/occlusion: 30 days - 1 year post study procedure 
 
Thrombosis should be reported as a cumulative value at the different time points and with the 
different separate time points. Time 0 is defined as the time point after the arterial sheath has been 
removed and the patient has left the interventional lab. 
Target Lesion 
 
The continuous diseased segment, between 3 cm and 15 cm in total length, in the superficial 
femoral or proximal (P1) popliteal arteries within 1 cm distal to the femoral bifurcation in the 
superficial femoral artery and 3 cm from the proximal margin of the intercondylar fossa and at 
least 2 cm from any stent if the vessel was previously stented. 
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. 
Peripheral Embolization 
Peripheral embolization is defined as a loss of distal pulse, pain and/or discoloration 
(especially the toes). This can include cholesterol emboli. Indicate whether a peripheral 
embolization occurred distal to the arterial access site during the procedure or after lab visit 
but before any subsequent lab visits, requiring therapy. 
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. 
Walking Impairment Questionnaire (WIQ): 
 
A disease-specific instrument utilized to characterize walking ability through a questionnaire as an 
alternative to treadmill testing. It is a measure of patient-perceived walking performance for patients 
with PAD and/or intermittent claudication. 
 
 

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APPENDIX C:  PATIENT INFORMED CONSENT : LBL1116 
(Note : the document included 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.) 
 
 

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APPENDIX D: DECLARATION OF HELSINKI 
(4 pages) 
 
 

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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 

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benefit personally from the research and for those for whom the research is combined with care.  
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.  

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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.  
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.  
 

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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.  
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.  
 
 

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The CVT-SFA Trial 
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APPENDIX E: INSTRUCTIONS FOR USE: LBL1117 
(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.) 
 
 

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The CVT-SFA Trial 
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APPENDIX F: SCHEDULE OF EVENTS 
(1 page) 
 
 

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PROCEDURE/TEST 
Prior to Procedure 
(Within 14 days) 
Pre-Procedure 
(Within 24 hours) 
PROCEDURE 
Pre-Discharge 
30 days (r7 days) 
Phone call or 
Office\hospital Visit 
180 days (r30 days) 
Office/hospital visit 
365 days (r30 days) 
Office /hospital visit 
24 and 36 months 
(r30 days) 
Patient Medical/Clinical 
History 
9
 
Chronic Concomitant 
Medications 
9
9
9
9
9 9
Patient Informed Consent 
9
 
General/Inclusion 
Exclusion 
9
 
Angiographic/Anatomic 
Inclusion/Exclusion Criteria 
 
9
 
Pregnancy Test (if 
applicable) 
9
 
Serum Hematology 
9
9* 
 
Blood Chemistry 
9
9* 
 
Peripheral Angiogram with 
Runoff 
 
99

Duplex Ultrasonography 
Examination 
9# 
9
9
9

Ankle Brachial Indices 
9
9
9
9

Rutherford-Becker 
Classification 
9
9
9
9

WIQ 
9
9
9

Walking Test or Treadmill Test 
9 
  
9 
9 
Per-protocol Medications 
 
999
 
Adverse Events 
 
99
9
9
9 9
 
#   optional 
*   If the subject presents with less than desired clinical outcome or symptoms of an adverse event  
 
 

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The CVT-SFA Trial 
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APPENDIX G: RESEARCH AGREEMENT TEMPLATE: FRM 1118 
(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, LLC 
The CVT-SFA Trial 
TP1109 Revision E 
 
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Page 72 of 79 
 
 
APPENDIX H: INVESTIGATOR’S RESPONSIBILITIES 
(1 page) 
 
 

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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. 

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The CVT-SFA Trial 
TP1109 Revision E 
 
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APPENDIX I: DUPLEX ULTRASONOGRAPHY CORE LAB GUIDELINES 
(10 pages) 
 
 

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CVT SFA
Examiner Worksheet
Completed worksheet
must accompany all
image submissions
Site #: _________    Subject #: _________     Exam Date: _______________
20210618_Ver.A
Proprietary & Confidential
Pre-discharge
6 month
12 month
Unscheduled, explain: _______________________
Visit
Right
Left
Study Limb
Proximal to TL
1-3cm above TL
0-2cm in TL
2-4cm in TL
PSV cm/sec
Examiner Name (please print): ________________________________________ Date: _________________
Comments (note any technical difficulties or unusual findings)
DD MMM YYYY
Compare exam to previous visits - check for interval changes and confirm location and length of TL.
DD MMM YYYY
Yes
No
TL Revascularization
If yes, date: _____________
Please retain a copy for your records
TL Length: __________cm
TL Proximal Edge: __________cm
TL Distal Edge: __________cm
CFA bifurcation
Superior edge of patella
Anatomical Marker
Peripheral Arterial Duplex Scan Findings
4-6cm in TL
DD MMM YYYY
Refer to the TL measurement form provided by the Angiographic Core Lab to complete this section
__ __ __
__ __ __
__ __ __
__ __ __
__ __ __
6-8cm in TL
8-10cm in TL
__ __ __
__ __ __
10-12cm in TL
12-14cm in TL
14-16cm in TL
1-3cm Distal to TL
Distal Popliteal
PSV cm/sec
__ __ __
__ __ __
__ __ __
__ __ __
__ __ __
Distal CFA __ __ __
Yes
No
Bailout Stent Placed


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

Chansu Vascular Technologies, LLC
The CVT-SFA Trial
TP1109 Revision E
Confidential
Page 75 of 79
APPENDIX J: RISK ANALYSIS
A full risk management file (
) is complete and available for the CVT Everolimus-coated PTA 
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 PTA Balloon Catheter were evaluated 
for the intended use listed on page one of this risk management and for deliberate misuse of the device.  
The analysis yielded two overall residual risk hazardous situations and resulting harms that are 
categorized as “High”:
ID
Hazard
Event
Hazardous 
Situation(s)
Potential Harm
Rate of 
Occurence
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%
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 

Chansu Vascular Technologies, LLC 
The CVT-SFA Trial 
TP1109 Revision E 
 
Confidential 
Page 76 of 79 
 
 
percutaneous interventional techniques 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 PTA catheters and stenting outweighs the 
incidence and severity of these risks. 
 
 

Chansu Vascular Technologies, LLC 
The CVT-SFA Trial 
TP1109 Revision E 
 
Confidential 
Page 77 of 79 
 
 
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-SFA Trial 
TP1109 Revision E 
 
Confidential 
Page 78 of 79 
 
 
APPENDIX L: CASE REPORT FORMS: FRM1119 
(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, LLC 
The CVT-SFA Trial 
TP1109 Revision E 
 
Confidential 
Page 79 of 79 
 
 
APPENDIX M:  ANGIOGRAPHIC CORE LAB GUIDELINES 
(3 Pages) 

                                                                                           Version 2.0 
Confidential and proprietary                                                                                                        Apr-13-2022 
 
 
CVT- SFA STUDY 
INSTRUCTIONS TO THE SITE 
 
All angiograms should be obtained paying strict attention to the following 
features: 
1) Please acquire all angiograms in DICOM format, at the highest magnification which 
will still incorporate the entire segment of stenosis within the field of view. 
 
2) A radio-opaque ruler must be used for calibration purposes, placed perpendicular to 
the imaging plane, flat on the patient. The ruler must be present in all film sequences 
to be analyzed. Once placed, the ruler should not be moved during the entire 
procedure. 
 
3) 7KHWDUJHWOHVLRQPXVWEHLPDJHGZKHQVXLWDEOHLQWZRYLHZVWKDWDUHGHJUHHV
apart to determine study eligibility.  
 
4) Please obtain an angiogram whenever suitable Subtracted and Unsubtracted, Cine 
Runs and Still Frames for each sequence and label them:  
 
            - Baseline-cine run 
            - Pre-dilatation balloon fully inflated 
 
- Post pre–dilatation -cine run                                                                                                                
 
- Study balloon fully inflated 
            - Post Study balloon-cine run 
 
- Adjunctive treatment, Balloon and/or Stent after deployment (For bail-out only)                                 
 
- Final -cine-run  
      - Complete Distal Runoff image of the lower extremity* at Baseline, Post 
pre-dilatation, post Study Balloon, after any treatment of dissection, and Final 
procedure 
*Lower extremity collection includes: target lesion, vessel distal to the target lesion, the 
popliteal, TP trunk, tibio-peroneal vessels, pedal arch and toes. 
5) Please film any complication that may occur during the procedure (e.g. dissection, 
perforation, abrupt closure, no reflow, thrombus, spasm, distal embolisation). 
 
6) Please document thoroughly all steps of intervention and each device used on the 
technician’s worksheet or procedure log.  
 
7) For DUS analysis, please image in one field of view the entire study vessel from CFA 
bifurcation to the distal edge of treatment 
 
8) Please label the CD with Site/Patient ID, Procedure date, Procedure Type (i.e. 
Index/Baseline, Clinical Event). 
 

                                                                                           Version 2.0 
Confidential and proprietary                                                                                                        Apr-13-2022 
 
 
9) For any clinical event required angiography please use the same guidelines and 
same settings as used at baseline, including a  complete Distal Runoff image 
 
 
 
 
PLEASE AVOID: 
x 
OBTAINING ANGIOGRAMS WITH ANY OF THE FOLLOWING: 
 
VESSEL OVERLAP 
 
FORESHORTENING 
 
STREAMING ARTIFACTS DUE TO TOO LITTLE CONTRAST 
x 
OVEREXPOSURE ("BURNOUT") BY USING WEDGE FILTERS  
x 
FILMING THE CATHETER OR STENOSIS IN THE OUTER PORTIONS OF THE IMAGE 
x 
SUPER VHS ARE NOT AN ACCEPTABLE FORMAT 
 
 
All Images should be uploaded into 
, including 
 
1. Cath Lab Procedure Log or Technician’s Worksheet Form (Please 
keep a copy of the original) 
2. Index/Baseline, Events Angiograms 
 
If needed, please Ship Films to: 
 
 
  
 
 
 
 
 
 
 
 
Please contact us anytime for questions. 
 
 
 
 
 
 
 
 

                                                                                           Version 2.0 
Confidential and proprietary                                                                                                        Apr-13-2022 
 
 
 
 
                              
 
 
 
 
   
  
  
  
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