A Non-Randomized, Post Marketing Clinical Follow-Up (PMCF) Study of the DESyne X2 Novolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions
Phase: NA
Conditions: Coronary Artery Disease
Sponsor: Elixir Medical Corporation

CONFIDENTAL AND PROPRIETARY 
Elixir Medical 
1 
Protocol ELX-CL-1705, Rev C, 18 September 2020 
 
A NON-RANDOMIZED, POST MARKETING CLINICAL FOLLOW-UP (PMCF) 
STUDY OF THE DESyne® X2 NOVOLIMUS ELUTING CORONARY STENT 
SYSTEM IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE 
CORONARY ARTERY LESIONS 
 
“DESyne X2 PMCF Study” 
ELX-CL-1705 
Revision C 
Date: 18 September 2020 
 
 
 
 
DATA MANAGEMENT 
AND STATISICAL 
ANALYSIS 
Elixir Medical, Milpitas, CA, USA. 
STUDY MONITOR 
Elixir Medical, Milpitas, CA, USA. 
STUDY SPONSOR                   Elixir Medical, Milpitas, CA, USA. 
 
 
 
 
Confidential and Proprietary 
Nothing herein is to be disclosed, reproduced or copied 
without the express written consent of Elixir Medical  
 
 

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Protocol ELX-CL-1705, Rev C, 18 September 2020 
PROTOCOL AMENDMENT SUMMARY OF CHANGES 
In this amendment the Sponsor is adding into the study the following:  the 2.25mm stent in 14, 18, 
23, 28, 32, and 38mm lengths, and an update to the inclusion and exclusion criteria to allow 
enrollment of a broader range of patients.  A few minor administrative updates are also included. A 
Table of Changes for the protocol is provided below.  These changes neither affect subjects’ rights, 
safety and welfare, nor the scientific soundness of the study.  The Coordinating Investigators and 
Principal Investigators have been updated on the changes. 
 
Protocol  
ELX-CL-1705 Rev B 
 
Change to protocol  
ELX-CL-1705 Rev C 
 
Location in 
Protocol 
/ 
Section 
Number 
Rationale 
 
Stent sizing included 
2.5 mm – 4.0mm 
diameters in the 14, 
18, 23, 28, 32, and 38 
mm lengths 
Stent sizing included 
2.25 mm – 4.0mm 
diameters in the 14, 
18, 23, 28, 32, and 38 
mm lengths 
Protocol 
Summary, 
Sections 2.2 
and 3.5.2 
The inclusion of 2.25mm stent in 14, 18, 23, 
28, 32 and 38mm lengths will allow 
enrollment of a broader range of patients 
Inclusion/Exclusion 
Criteria 
Changes to 
inclusion/exclusion 
criteria 
Protocol 
Summary, 
Sections 3.1, 
3.2, 3.3 and 
3.5.2  
Inclusion are broadened and exclusion 
criteria reworded to allow a wider range 
of patient inclusion.  These changes 
include:   
• Single site inclusion of up to 40 
patients or (40% of the total patients)   
• No 4. Inclusion of 2.25mm lesions, 
and inclusion of up to 3 lesions in 
separate epicardial vessels.   
• Exclusion criteria:  No. 3. clarification 
of previous stent implantation location 
(removal of “distal”);  
• replacement of  No. 8 “Lesion 
involvement of a significant side 
branch (branch diameter > 2 mm) that 
would be covered by stenting” with 
“Bifurcation lesion with planned 2-
stent technique”; 
• rewording of No. 11 MI exclusion to 
“Patient has a diagnosis of ST 
elevation myocardial infarction 
(STEMI) within 72 hours preceding 
the index procedure, and CK and CK-
MB have not returned within normal 
limits at the time of procedure”;  

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Protocol ELX-CL-1705, Rev C, 18 September 2020 
• rewording of No. 14 “patients 
participating in another investigational 
device study that has not completed 
the primary follow-up phase” to 
“patient is currently participating in 
another investigational device study 
that has not completed the primary 
follow-up phase, or patients 
participating in any DAPT or other 
thrombus/platelet related studies that 
that has not completed the primary 
follow-up phase, or enrolled into more 
than one study on the day of the index 
procedure.” 
These changes neither affects subjects’ 
rights, safety and welfare, nor the scientific 
soundness of the study. 
Time Course 
enrollment start Q1 
2019 and enrollment 
completion Q3 2019 
Time Course 
enrollment start Q2 
2020 and enrollment 
completion Q1 2021 
Protocol 
Summary 
Extension of the Time Course for the study 
to accommodate the late start of the study 
enrollment 
Bailout  
Use of non-DESyne 
X2 Stent in case of 
bailout 
Bailout  
Include 
use 
of  
DESyne X2 Stent in 
case of bailout  
Section 
3.5.3 
The DESyne X2 stent maybe used for 
bailout in cases of dissection, occlusive 
complication 
or 
incomplete 
lesion 
coverage 
requiring 
additional 
stent 
placement.  
 
Minor administrative 
changes 
and 
spelling/formatting 
corrections 
Throughout 
Protocol 
Minor administrative changes, minor 
clarifications, spelling and formatting 
corrections.   

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Protocol ELX-CL-1705, Rev C, 18 September 2020 
TABLE OF CONTENTS 
PROTOCOL AMENDMENT SUMMARY OF CHANGES ..................................................................... 2 
1.0 
DESYNE X2 PMCF PROTOCOL SUMMARY .......................................................................... 6 
2.0 
INTRODUCTION ........................................................................................................................... 9 
2.1 
BACKGROUND AND RATIONALE .......................................................................................... 9 
2.2 
DESYNE® X2 NOVOLIMUS ELUTING STENTS CORONARY STENT SYSTEM ....................... 10 
 
Novolimus ........................................................................................................... 11 
 
Polymer Coating ................................................................................................. 11 
2.3 
RISK ASSESSMENT ............................................................................................................. 12 
2.4 
STUDY OBJECTIVES ........................................................................................................... 12 
2.5 
SUMMARY OF STUDY DESIGN ............................................................................................ 12 
2.6 
STUDY ENDPOINTS ............................................................................................................ 12 
3.0 
MATERIALS AND METHODS .................................................................................................. 13 
3.1 
SELECTION OF SUBJECTS ................................................................................................... 13 
3.2 
INCLUSION CRITERIA ......................................................................................................... 13 
3.3 
EXCLUSION CRITERIA ........................................................................................................ 14 
3.4 
INFORMED CONSENT ......................................................................................................... 14 
3.5 
CONDUCT OF THE STUDY ................................................................................................... 15 
 
Screening Procedures and Patient Enrollment Prior to Catheterization ........... 15 
 
Catheterization and Stenting Procedure ............................................................. 15 
 
Bailout Procedures ............................................................................................. 16 
 
Treatment Failures ............................................................................................. 16 
 
Concomitant Medical Therapy ........................................................................... 16 
 
Clinical and Laboratory Procedures .................................................................. 17 
 
Other Follow-up Guidelines ............................................................................... 17 
4.0 
ENDPOINTS ................................................................................................................................. 17 
4.1 
LESION, VESSEL, AND STENT CHARACTERISTICS ................................................................ 17 
4.2 
DEVICE AND DRUG RELATED ADVERSE EVENTS ............................................................... 18 
5.0 
EARLY WITHDRAWAL FROM THE STUDY ....................................................................... 18 
6.0 
STATISTICAL CONSIDERATIONS ......................................................................................... 18 
7.0 
DATA MONITORING AND QUALITY CONTROL ............................................................... 19 
7.1 
REQUIRED DATA ............................................................................................................... 19 
7.2 
TRAINING .......................................................................................................................... 19 
7.3 
LOGS AND CASE REPORT FORMS ....................................................................................... 19 
7.4 
DATA COLLECTION, MONITORING, AND TRACKING .......................................................... 19 
8.0 
ETHICAL AND REGULATORY CONSIDERATIONS .......................................................... 19 
8.1 
INVESTIGATOR RESPONSIBILITIES AND PERFORMANCE ..................................................... 19 

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Protocol ELX-CL-1705, Rev C, 18 September 2020 
 
Informed Consent and IRB/Ethics Committee Approval .................................... 20 
 
Source Documentation ....................................................................................... 20 
 
Record Retention ................................................................................................ 20 
 
Non-Protocol Research ...................................................................................... 20 
8.2 
ROLE OF THE SPONSOR - ELIXIR MEDICAL ........................................................................ 21 
 
General Duties .................................................................................................... 21 
 
Selection and Monitoring of Clinical Sites and Investigators ............................ 21 
 
Maintaining Records .......................................................................................... 21 
 
Submitting Reports ............................................................................................. 21 
 
Patient Confidentiality ........................................................................................ 22 
 
Publication Policies ............................................................................................ 22 
9.0 
DEFINITIONS .............................................................................................................................. 22 
10.0 
APPENDIX I:  SAMPLE PATIENT INFORMED CONSENT ................................................ 26 
 
 
 

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Protocol ELX-CL-1705, Rev C, 18 September 2020 
1.0 
DESyne X2 PMCF PROTOCOL SUMMARY 
Design: 
Prospective, non-randomized, multicenter, international Post 
Marketing Clinical Follow-up (PMCF) study 
Enrollment: 
Enrollment of up to 100 patients with up to three de novo native 
coronary artery lesions measuring between 2.25 and 4.0 mm in 
diameter and ≤ 34 mm in length receiving the DESyne X2 
Novolimus Eluting Coronary Stent System (CSS).   
Clinical Site 
Locations: 
Drawn from up to 10 International Sites 
Objective and 
Rationale: 
To confirm the performance of the DESyne X2 Novolimus Eluting 
Coronary Stent System with regards to the residual risks of lesion 
access and acute device implantation through visually-assessed 
angiographic endpoints and physician feedback and demonstrate that 
these characteristics are not different than the DESyne Novolimus 
Eluting CSS.  
A single-arm study comparing the DESyne X2 PMCF data to the 
historic DESyne acute performance data will confirm that the 
DESyne X2 delivery system performs similarly to the DESyne 
delivery system.  
Key Endpoints: 
Acute Device Success: attainment of final result with < 50% residual 
stenosis of the target site, using a DESyne X2 stent and standard pre-
dilation catheters and post-dilatation catheters (if applicable) 
Device preparation  
Lesion access and cross 
Stent expansion  
Delivery system removal  
Stent crossability for post-dilatation as required 
Device malfunction assessment 
Time Course: 
Initial Enrollment    
 
 
Q3 2020 
Enrollment Complete   
 
Q2 2021 
Inclusion 
Criteria: 
Candidates for this study must meet all of the following criteria: 
1) The patient must be ≥18 years of age. 
2) The patient must have stable angina pectoris as defined by 
the 
Canadian 
Cardiovascular 
Society 
Classification, 
documented silent ischemia, acute coronary syndrome, or a 
positive functional study requiring treatment 
3) The patient is considered a candidate for coronary stent 
implantation and has a planned intervention of up to 

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Protocol ELX-CL-1705, Rev C, 18 September 2020 
three lesions located in separate major epicardial territories. 
Each lesion/vessel must meet the following criteria: 
a. De novo lesion 
b. The target lesion reference site must be visually 
estimated to be ≥ 2.25 mm and ≤ 4.0 mm in diameter* 
c. The target vessel must be a major coronary artery or 
major branch with a visually estimated stenosis of 
≥ 50% and < 100%. 
d. The visually estimated target lesion length must be 
≤ 34 mm*  
e. ≥ TIMI 1 coronary flow 
*Subject to commercial availability of product sizes in the specific 
region/country 
Exclusion 
Criteria:  
Candidates will be ineligible for enrollment in the study if any of the 
following conditions apply: 
1) The patient has a known hypersensitivity or contraindication 
to aspirin, heparin, ticlopidine, clopidogrel, prasugrel or 
ticagrelor, heparin/bivalirudin, mTOR inhibitor class drugs, 
cobalt chromium alloy, methacrylate or polylactide polymer, 
or sensitivity to contrast which cannot be adequately 
premedicated 
2) Women of childbearing potential who have not undergone 
surgical sterilization or are not post-menopausal (defined as 
amenorrheic for at least one year) as well as women who are 
pregnant or nursing  
3) Previous placement of a stent within 10 mm of the target 
lesion 
4) Previous placement of a stent proximal to the target lesion 
5) Total occlusion or < TIMI 1 coronary flow in the target 
vessel 
6) The proximal target vessel or target lesion is severely 
calcified by visual assessment 
7) Aorto-ostial location, unprotected left main lesion location, 
or a lesion within 5 mm of the origin of the LAD or LCX 
8) Bifurcation lesion with planned 2-stent technique 
9) High probability that treatment other than PTCA or stenting 
will be required for treatment of the same lesion 

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Protocol ELX-CL-1705, Rev C, 18 September 2020 
10) The target lesion, or the target vessel proximal to the target 
lesion, contains thrombus 
11) Patient has a diagnosis of ST elevation myocardial infarction 
(STEMI) 
within 
72 
hours 
preceding 
the 
index 
procedure, and CK and CK-MB have not returned within 
normal limits at the time of procedure  
12) The patient is a recipient of a heart transplant 
13) The patient has extensive peripheral vascular disease that 
precludes safe sheath insertion or extreme anti-coagulation 
14) The 
patient 
is 
currently 
participating 
in 
another 
investigational device study that has not completed the 
primary follow-up phase, or patients participating in any 
DAPT or other thrombus/platelet related studies that that has 
not completed the primary follow-up phase, or enrolled into 
more than one study on the day of the index procedure. 
15) Patients who are unable or unwilling to cooperate with study 
procedures 
Clinical and 
Laboratory 
Procedures: 
It is recommended that the hospital standard testing for coronary 
stent placement such as an electrocardiogram and cardiac enzymes 
are completed.  
Concomitant 
Medical 
Therapy: 
It is recommended that all patients receive dual antiplatelet therapy 
including aspirin and thienopyridine/P2Y12 Inhibitor for at least one 
year as currently recommended by the AHA/ACC guidelines and 
hospital standards.    
 
 

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Elixir Medical 
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Protocol ELX-CL-1705, Rev C, 18 September 2020 
 
A NON-RANDOMIZED, POST MARKETING CLINICAL FOLLOW-UP (PMCF) 
STUDY OF THE DESyne® X2 NOVOLIMUS ELUTING CORONARY STENT 
SYSTEM IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE 
CORONARY ARTERY LESIONS 
 
“DESyne X2 PMCF Study” 
ELX-CL-1705 
Revision C 
Date: 18 September 2020 
 
 
2.0 
INTRODUCTION 
2.1 
Background and Rationale 
Pertinent prior clinical experience with Elixir’s DESyne or DESyne BD Novolimus Eluting 
Coronary Stent System (CSS) includes two randomized studies: the EXCELLA II 
Randomized Study - Phase 1 and the EXCELLA II Randomized Study – Phase 2.   
The EXCELLA II Randomized Clinical Trial - Phase 1 was a single blind, consecutive 
enrollment, non-inferiority trial which enrolled a total of 210 patients at 21 international 
sites wherein the Principal Investigator was Professor Patrick W. Serruys, MD, PhD.  
Co-Principal Investigators included Alexandre Abizaid, MD, PhD, John Ormiston, MD 
and Stephan Windecker, MD.  The study was designed to evaluate the safety and efficacy 
of the Elixir DESyne Novolimus Eluting Coronary Stent System as compared to the 
Endeavor Zotarolimus Eluting Coronary Stent System (Medtronic Vascular, Santa Rosa, 
CA).  The primary endpoint for this study was the in-stent late lumen loss assessed by QCA 
at 9 months.  Key secondary endpoints included the device-oriented composite endpoint 
(DoCE) inclusive of cardiac death, myocardial infarction attributable to the target lesion 
and clinically-indicated target lesion revascularization evaluated at 30 days, 6, 9, 12 and 
24 months.  The in-stent percent volume obstruction (%VO) was measured in a sub-group 
of 65 patients having 9-month intra-vascular ultrasound (IVUS) follow-up. 
At 9-months, the in-stent late lumen loss was 0.11 ± 0.32 mm in the DESyne stent arm, as 
compared to 0.63 ± 0.42 mm in the Endeavor stent arm (p<0.001 non-inferiority, p<0.001 
superiority). In-stent %VO by IVUS was 4.5 ± 5.1% and 20.9 ± 11.3% for the DESyne 
stent and the Endeavor stent, respectively (p<0.001). There was a significant difference 
between stent groups in the device orientated composite endpoint (DESyne 7.9% vs. 

CONFIDENTAL AND PROPRIETARY 
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Protocol ELX-CL-1705, Rev C, 18 September 2020 
Endeavor 19.7%, p=0.02) indicating superior clinical results driven primarily by the 
reduction in TLR for the DESyne stent.1  . 
The EXCELLA II Phase 2 Randomized Clinical Trial is a single blind, consecutive 
enrollment, non-inferiority trial which enrolled a total of 145 patients at 11 international 
sites.  The study was designed to evaluate the safety and efficacy of the Elixir DESyne BD 
Novolimus Eluting Coronary Stent System with bioabsorbable polymer as compared to the 
Endeavor Zotarolimus Eluting Coronary Stent System (Medtronic Vascular, Santa Rosa, 
CA).  The primary endpoint for this study is in-stent late lumen loss assessed by QCA at 6 
months.  Key secondary endpoints include a device-oriented composite endpoint inclusive 
of cardiac death, myocardial infarction attributable to the target lesion and clinically-
indicated target lesion revascularization evaluated at 30 days, 6, 9, and 12 months and 
annually through 5 years as well as additional angiographic and IVUS endpoints.  Patient 
enrollment into this study is complete with follow-ups ongoing through 5 years.   
At 6 months, the primary endpoint of mean in-stent LLL was significantly lower for the 
DESyne BD Novolimus Eluting CSS compared to the Endeavor Zotarolimus-Eluting CSS, 
(0.12 ± 0.15 mm vs. 0.67 ± 0.47 mm, non-inferiority p<0.001, superiority p<0.001.  At 60 
months, there was no significant difference between study arms in the modified intent to 
treat (MITT) analysis of the device orientated composite endpoint (DESyne BD Novolimus 
Eluting CSS 8.0% vs. Endeavor Zotarolimus-Eluting CSS 9.7%, p = 0.72) or its individual 
components of cardiac death, target vessel MI and CI-TLR.   
The DESyne Novolimus Eluting Coronary Stent System and the DESyne BD Novolimus 
Eluting Coronary Stent System have both demonstrated excellent results in clinical studies 
to date.   
2.2 
DESyne® X2 Novolimus Eluting Stents Coronary Stent System 
The DESyne® X2 Novolimus Eluting Coronary Stent Systems is comprised of four key 
components including the delivery system, stent, the active drug substance Novolimus, and 
polymer that controls the release of the drug.  The stent, drug substance, drug dose, and 
polymer of the DESyne X2 NECSS are the same as those used in the DESyne NECSS.  
The stent, drug substance, and drug dose are the same as those used in the DESyne BD 
NECSS.  The main difference between the DESyne X2 NECSS and the DESyne and 
DESyne BD NECSS is the delivery system used on the DESyne X2 NECSS.  The updated 
delivery system is used in the same manner and has the same accessory compatibility as 
the DESyne and DESyne BD delivery systems.  The delivery systems have differences 
with respect to dimensions and materials; however these dimensions and materials similar 
to other percutaneous balloon delivery systems. 
                                                 
1 Iqbal, J, Verheye, S, Abizaid, A, et al., DESyne Novolimus-Eluting Coronary Stent Is Superior to 
Endeavor Zotarolimus-Eluting Coronary Stent at Five-Year Follow-up: Final Results of the 
Multicentre EXCELLA II Randomised Controlled Trial. EuroInter. 2016 Dec;12(11):e1336-
e1342. 

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The DESyne X2 delivery system provides a means for carrying the stent through the 
coronary vasculature to the desired location and expanding the stent through inflation of 
the balloon.  The delivery system is comprised of standard materials with a stainless steel 
hypotube proximally, a nylon blend shaft distally and nylon blend balloon.  The 
premounted stent is made of cobalt chromium alloy.  It is available in diameters of 2.5 mm, 
2.75 mm, 3.0 mm, 3.5 mm and 4.0 mm with lengths of 14 mm, 18 mm, 28 mm, 32 mm and 
38 mm2.  The stent has a nominal strut thickness of 0.0032” (0.08 mm) with an 8-crown 
pattern for the 3.0, 3.5, and 4.0 mm sizes and a 6-crown pattern for the 2.25, 2.5 and 2.75 
mm sizes.  The DESyne X2 delivery system is substantially similar to the DESyne and 
DESyne BD delivery systems.   
The DESyne X2 Novolimus Eluting Coronary Stent Systems to be evaluated in this study 
are loaded with approximately 5 mcg of Novolimus per mm of stent length (85 mcg for an 
18 mm stent).  The DESyne stent is coated with a formulation comprised of Novolimus 
and a proprietary durable methacrylate polymer which allows sustained release of the drug 
over a period of 12 weeks.  Detailed information on the DESyne X2 Novolimus Eluting 
CSS can be found in the Instructions for Use. 
 Novolimus 
Novolimus is a metabolite of sirolimus and belongs to the family of compounds of 
macrocyclic lactones with immunosuppressive and anti-proliferative properties and has a 
similar mechanism of action to other macrocylic lactones such as rapamycin.  Macrocyclic 
lactones bind to the immunophilin, FK Binding Protein-12 (FKBP-12), to generate an 
immunosuppressive complex. This complex binds to and inhibits the activation of the 
mammalian Target of Rapamycin (mTOR), a key regulatory kinase. This inhibition 
suppresses cytokine-driven cell proliferation, inhibiting the progression from the G1 to the 
S phase of the cell cycle.  As stated above, this is the same drug used on the DESyne 
NECSS and the DESyne BD NECSS. 
 Polymer Coating 
The polymer coating is mixed with the drug and applied over the entire surface of the stent.  
The purpose of either the durable polymer coating is to moderate the delivery of the drug 
over a period of time. The durable coating is a methacrylate polymer and is similar to 
polymers that have been used clinically on vascular implants and proven to be safe.  The 
coating and drug provide a thin layer on the stent but do not affect the overall performance 
of the stent.  Note that the amount of polymer applied to the stent is substantially less than 
other available DES devices using similar polymers.  As stated above, this is the same 
polymer used on the DESyne NECSS. 
                                                 
2 Not all lengths available in all regions.  Subject to commercial availability.  Availability is based on 
regulatory and hospital approvals. 

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Protocol ELX-CL-1705, Rev C, 18 September 2020 
2.3 
Risk Assessment 
The Elixir DESyne and DESyne BD Novolimus Eluting Coronary Stent Systems have 
demonstrated excellent clinical safety and efficacy in both the EXCELLA II Randomized 
Study – Phases 1 and 2.  Both of these systems have received CE Mark approval.  A post 
market clinical follow-up study of the DESyne X2 device, which has also received CE 
Mark approval, is desired to confirm the performance of the DESyne X2 Novolimus 
Eluting Coronary Stent System with regards to the residual risks of lesion access and acute 
device implantation through visually-assessed angiographic endpoints and physician 
feedback and demonstrate that these characteristics are not different than the DESyne 
Novolimus Eluting CSS.  These attributes are most directly related to the performance of 
the updated delivery system, including stent mounting on the delivery system balloon.   
The safety profile and the known mechanism of action of the drug, Novolimus, and the 
biocompatibility of both the durable methacrylate polymer coating in combination with the 
scaffolding properties of the DESyne CSS provide a safe and effective method for reducing 
neointimal hyperplasia. Therefore, the benefits of the acute lesion scaffolding and long-
term reduced incidence of restenosis in the treatment of ischemic coronary artery disease 
have already been demonstrated to outweigh the risks associated with the use of these 
devices and are applicable to the DESyne X2 NECSS.  The use of the DESyne X2 NECSS 
has the same risk profile as the DESyne NECSS and the DESyne BD NECSS.  No 
differences in risk or the risk/benefit ratio are expected with the use of the updated delivery 
system of the DESyne X2 NECSS. 
2.4 
Study Objectives 
A single-arm post-market follow-up study (PMCF) comparing the DESyne X2 PMCF data 
to the historic DESyne acute performance data to confirm the performance of the DESyne 
X2 Novolimus Eluting Coronary Stent System with regards to the residual risks of lesion 
access and acute device implantation through visually-assessed angiographic endpoints 
and physician feedback. 
2.5 
Summary of Study Design  
This PMCF study will enroll up to 100 male and female patients with up to two de novo 
native coronary artery lesions who satisfy all entry criteria.  Study endpoints will be 
summarized.  
2.6 
Study Endpoints 
The endpoints for this post-marketing clinical follow-up study include:  
• Acute Device Success: attainment of final result with < 50% residual stenosis of 
the target site, using a DESyne X2 stent and standard pre-dilation catheters and 
post-dilatation catheters (if applicable) 

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Protocol ELX-CL-1705, Rev C, 18 September 2020 
Physician feedback will be obtained for the following device characteristics: 
• Device preparation  
• Lesion access and cross 
• Stent expansion  
• Delivery system removal  
• Stent crossability for post-dilatation as required 
• Device malfunction assessment   
3.0 
MATERIALS AND METHODS 
3.1 
Selection of Subjects 
The study will include up to 100 male and female patients all with de novo native coronary 
artery lesions who meet eligibility criteria and agree to participate in the trial.  Sites may 
enroll up to a maximum of 40 patients per site, or 40% of the total number of enrolled 
patients.   
3.2 
Inclusion Criteria  
Candidates for this study must meet all of the following criteria: 
1) The patient must be ≥18 years of age 
2) Patient is able to verbally confirm understanding of risks, benefits and treatment 
alternatives of receiving the DESyne X2 NECSS and he/she provides written 
informed consent, as approved by the appropriate Ethics Committee of the 
respective clinical site, prior to any clinical study related procedure 
3) The patient must have stable angina pectoris as defined by the Canadian 
Cardiovascular Society Classification, documented silent ischemia, acute coronary 
syndrome, or a positive functional study requiring treatment 
4) The patient is considered a candidate for coronary stent implantation and has a 
planned intervention of up to three lesions located in separate major epicardial 
territories. Each lesion/vessel must meet the following criteria: 
a. De novo lesion 
b. The target lesion reference site must be visually estimated to be ≥ 2.25 mm 
and ≤ 4.0 mm in diameter* 
c. The target vessel must be a major coronary artery or major branch with a 
visually estimated stenosis of ≥ 50% and <100%. 
d. The visually estimated target lesion length must be ≤ 34 mm*  
≥ TIMI 1 coronary flow 
*Subject to commercial availability of product sizes in the specific 
region/country 

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Protocol ELX-CL-1705, Rev C, 18 September 2020 
3.3 
Exclusion Criteria  
Candidates will be ineligible for enrollment in the study if any of the following conditions 
apply: 
1) The patient has a known hypersensitivity or contraindication to aspirin, heparin, 
ticlopidine, clopidogrel, prasugrel or ticagrelor, heparin/bivalirudin, mTOR 
inhibitor class drugs, cobalt chromium alloy, methacrylate or polylactide polymer, 
or sensitivity to contrast which cannot be adequately premedicated 
2) Women of childbearing potential who have not undergone surgical sterilization or 
are not post-menopausal (defined as amenorrheic for at least one year) as well as 
women who are pregnant or nursing  
3) Previous placement of a stent within 10 mm of the target lesion 
4) Previous placement of a stent proximal to the target lesion 
5) Total occlusion or < TIMI 1 coronary flow in the target vessel 
6) The proximal target vessel or target lesion is severely calcified by visual assessment 
7) Aorto-ostial location, unprotected left main lesion location, or a lesion within 5 mm 
of the origin of the LAD or LCX 
8) Bifurcation lesion with planned 2-stent technique 
9) High probability that treatment other than PTCA or stenting will be required for 
treatment of the same lesion 
10) The target lesion, or the target vessel proximal to the target lesion, contains 
thrombus 
11) Patient has a diagnosis of ST elevation myocardial infarction (STEMI) within 72 
hours preceding the index procedure, and CK and CK-MB have not returned within 
normal limits at the time of procedure  
12) The patient is a recipient of a heart transplant 
13) The patient has extensive peripheral vascular disease that precludes safe sheath 
insertion or extreme anti-coagulation 
14) The patient is currently participating in another investigational device study that 
has not completed the primary follow-up phase, or patients participating in any 
DAPT or other thrombus/platelet related studies that that has not completed the 
primary follow-up phase, or enrolled into more than one study on the day of the 
index procedure. 
15) Patients who are unable or unwilling to cooperate with study procedures 
3.4 
Informed Consent 
If a patient is potentially eligible for the study, the patient and patient’s family if available 
should be approached.  The background of the proposed study and the benefits and risks 
of the procedures should be explained to the patient.  In accordance with the Declaration 

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Protocol ELX-CL-1705, Rev C, 18 September 2020 
of Helsinki (2013), the patient must provide consent prior to enrollment (see Appendix I 
for an example of the consent form).  Failure to obtain signed, informed consent prior to 
enrollment into the study renders the patient ineligible. 
3.5 
Conduct of the Study 
 Screening Procedures and Patient Enrollment Prior to 
Catheterization 
All patients admitted for percutaneous revascularization should be assessed for potential 
study eligibility.   
 Catheterization and Stenting Procedure 
The stenting procedure will follow standard procedures for balloon angioplasty and shall 
be in accordance with the Instructions for Use packaged with each DESyne X2 stent.  The 
available stent diameters are  2.25 mm, 2.75 mm, 3.0 mm, 3.5 mm, and 4.0 mm with stent 
lengths of 14 mm, 18 mm, 23 mm 28 mm, 32 mm, and 38 mm lengths.3    Pre-dilate the 
lesion using a balloon that is shorter in length than the planned DESyne X2 stent length.  
Deploy the stent slowly until the stent is completely expanded. Maintain pressure for 30 
seconds. Direct stenting is not recommended. 
• Should any resistance be felt at any time during either lesion access or removal of 
the delivery system post stent implantation, the entire system should be removed as 
a single unit (See appropriate IFU for further information). 
• According to the IFU, stent expansion should not exceed the RBP of 16 atm and 
the stent should not be expanded beyond 0.5 mm over the nominal diameter. 
Evaluate the lesion via angiography.  If an optimal angiographic result has still not been 
achieved using the coronary stent system, additional balloon inflations using an 
appropriately sized, non-compliant balloon may be performed.   
The stenting procedure will include a single lesion treatment in a single epicardial vessel 
or a single lesion treatment in up to three separate major epicardial territories. 
Maintain a copy of all of the index procedure angiographic images for possible analysis by 
an independent angiographic core laboratory.  
 
 
 
 
                                                 
3 Not all sizes available in all regions. Subject to commercial availability. Availability is based on regulatory 
and hospital approvals. 

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Flowchart for Treatment of Two Lesions in Two Separate Epicardial Territories 
 
 
 
 
 
 
 
Second lesion                               is treated with an  
 
 
Optimal lesion/vessel treatment is defined as:  
 
a. < 20% residual stenosis by visual assessment  
b. no evidence of dissection  
c. no evidence of thrombus in the target lesion or vessel 
d. TIMI 3 flow 
 Bailout Procedures 
In the event that a patient experiences a dissection or an occlusive complication or if there 
is incomplete lesion coverage, further stenting may be employed as a bailout treatment 
using a DESyne X2 stent or other  commercially available stent of the same metal 
composition and the same drug family.  The stents should overlap by at least 1-2 mm. 
 Treatment Failures 
Failure to implant the DESyne X2 stent at the intended target site will be recorded as a 
treatment failure on the case report form.  In the event of the inability to treat the lesion 
with the study stent, the physician may treat the patient according to his/her medical 
judgment with another approved device.  These patients should receive standard anti-
platelet therapy. 
 Concomitant Medical Therapy 
It is recommended that all patients receive dual antiplatelet therapy including aspirin and 
aP2Y12 inhibitor for at least one year as currently recommended by the AHA/ACC 
guidelines and hospital standards. 
Patient has  up to three single, de novo lesions in 
separate major epicardial territories, which meet all 
inclusion/exclusion criteria 
A target lesion is identified and treated  with a DESyne X2 
stent. 
Stent implantation result is 
classified as optimal. 
Each additional target lesion is 
treated with a DESyne X2 stent 
and classified as optimal before 
treating the next lesion   
Stent implantation result is NOT 
classified as optimal. 
Additional target lesion is NOT 
treated with a DESyne X2 stent. 

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Protocol ELX-CL-1705, Rev C, 18 September 2020 
 Clinical and Laboratory Procedures 
It is recommended to perform an electrocardiogram and cardiac enzymes be assessed prior 
to the procedure and post-procedure as per hospital standard. 
 Other Follow-up Guidelines 
There may be situations where an attempt to treat the patient with the DESyne X2 stent is 
made, but the procedure is stopped prior to the stent being delivered to the target site (i.e., 
the stent is introduced into the guiding catheter and circulation but patient becomes 
unstable, power outage, etc.).  In these situations, the patient will be deregistered from the 
study and treated per standard hospital practice. 
 
In the situation where an attempt to treat the patient with the DESyne X2 stent is made but 
due to a device malfunction or failure to cross the lesion, no DESyne X2 stent is 
subsequently implanted, the case shall be noted as not meeting the Device Success 
endpoint.  All device failures will be recorded and reported. 
4.0 
ENDPOINTS 
The following endpoints chosen for the post market clinical follow-up evaluation are the 
recognized professional and industry standards in determining performance of drug eluting 
stents in interventional cardiology.   
• Acute Device Success: attainment of final result with < 50% residual stenosis of 
the target site, using a DESyne X2 stent and standard pre-dilation catheters and 
post-dilatation catheters (if applicable) 
Physician feedback will be obtained for the following device characteristics: 
• Device preparation  
• Lesion access and cross 
• Stent expansion  
• Delivery system removal  
• Stent crossability for post-dilatation as required 
• Device malfunction assessment 
4.1 
Lesion, vessel, and stent characteristics 
Lesion, vessel, and stent characteristics recorded in the source documentation should 
include: 
• Estimated reference vessel diameter (target lesion) 
• Estimated lesion length 
• Estimated % DS (target lesion) 

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• Number of stents used 
• Stent brand 
• Vessel (LAD, LCX, RCA, Left Main) 
• Lesion location (ostial, proximal, mid, distal, branch) 
• Stent diameter (mm) 
• Stent length (mm) 
• Lot number of the DESyne X2 stent 
• Success of stent implantation or device malfunction details  
Note:  Maintain a copy of all of the index procedure angiography for possible analysis by 
an angiographic core laboratory. 
4.2 
Device and Drug Related Adverse Events 
A list of adverse events which may result from the use of the device, the implant procedure, 
the drug on the stent, or the use of concomitant procedural drugs are described in the 
Instructions for Use for each device.  
5.0 
EARLY WITHDRAWAL FROM THE STUDY 
Following the introduction into the body of the intended device, all patients are considered 
enrolled into the study.  Patients will be exempt from only if they withdraw their consent 
or the physician withdraws them from the study. 
6.0 
STATISTICAL CONSIDERATIONS 
This Post Marketing Clinical Follow-up (PMCF) study is designed to confirm the 
performance of the DESyne X2 Novolimus Eluting Coronary Stent System with regards to 
the residual risks of lesion access and acute device implantation through visually-assessed 
angiographic endpoints and physician feedback and demonstrate that these characteristics 
are not different than the DESyne Novolimus Eluting CSS.  The overall result of this study 
will be summarized descriptively, and examined relative to the clinical results observed in 
the EXCELLA II Randomized Study. 
Data for all categorical endpoints will be summarized with patient counts, percentages, and 
exact 95% Clopper-Pearson confidence intervals. 
One study population will be examined during the analyses: the modified intent-to-treat 
population (MITT), which will consist of all patients treated with at least one DESyne X2 
stent. 
While this post marketing study is not powered to determine extremely rare events, a 
sample size of 100 patients is sufficient to detect rare, acute device related performance 
issues.   

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7.0 
DATA MONITORING AND QUALITY CONTROL 
7.1 
Required Data 
All required data for this trial will be collected using Case Report Forms (CRF). Only 
authorized personnel will be permitted to enter data on the CRFs. The computerized 
handling of the data by the sponsor and/or designee after receipt of the CRFs may generate 
additional requests to which the investigator is obliged to respond by confirming or 
modifying the data questioned. 
7.2 
Training 
The training of appropriate clinical site personnel will be the responsibility of the study 
sponsor, Elixir Medical, or their appointed designee. 
7.3 
Logs and Case Report Forms 
An authorized signature log, screening log, protocol deviation log, and issues log will be 
maintained by the investigative site and be available for review by the sponsor when 
requested.  All appropriate CRFs should be completed as soon as possible after enrollment 
or follow-up contact with the patient.  Submission of the CRFs will be coordinated between 
the investigative site and the data management group.  This includes coordination of data 
discrepancy forms. 
7.4 
Data Collection, Monitoring, and Tracking 
The sponsor and/or designee will monitor the study over its duration according to the pre-
specified monitoring plan. The study monitor will utilize an electronic database system to 
collect completed CRFs and monitor study progress. The study monitor may visit the sites 
to review investigational data for accuracy and completeness and ensure compliance with 
the protocol or may require redacted documents to be forwarded by electronic means for 
off-site examination.  
The study monitor may inspect all documents and required records that are maintained by 
the investigator or investigative site, including medical records (office, clinic or hospital) 
for the patients in this study.  The investigator and site will permit access to such records. 
Source documentation must be available to substantiate proper informed consent 
procedures, adherence to protocol procedures, adequate reporting and follow-up of adverse 
events, accuracy of data collected on case report forms, and device information. 
8.0 
ETHICAL AND REGULATORY CONSIDERATIONS  
8.1 
Investigator Responsibilities and Performance 
The investigator shall ensure that all work and services shall be conducted in accordance 
with the highest standards of medical and clinical research practice.  The investigator will 
provide copies of the study protocol to all sub-investigators or other staff responsible for 
study conduct. 

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 Informed Consent and IRB/Ethics Committee Approval 
Institutional Review Board (IRB) or Ethics Committee (EC) written approval for the 
protocol, protocol amendments, and informed consent form will be obtained by each 
Investigator prior to initiation of patient enrollment in this study.  Until the study is 
completed, each Investigator will update the IRB/Ethics Committee per institutional 
requirements. 
 Source Documentation 
Regulations require that investigators maintain information in the study subject’s medical 
records which corroborate the data collected on the case report forms.  In order to comply 
with these regulatory requirements, the following information should be maintained: 
• Medical history and physical condition of the study subject before involvement in 
the study sufficient to verify protocol entry criteria 
• Dated and signed notes on the day of entry into the study including the study 
sponsor name (Elixir Medical)  
• Notes regarding device information and performance and concomitant medications 
taken during the study 
• Study subject’s condition upon completion of or withdrawal from the study 
 Record Retention 
Site specific essential documentation of study conduct to be maintained at the site will 
include:  completed CRFs and data correction forms, internal and external correspondence; 
agreements, logs (authorized signatures, monitoring, screening, protocol deviations, 
issues), and any other trial-related documents. 
The investigator shall maintain the clinical investigation documents as required by the 
applicable regulatory requirement(s). All investigative sites will maintain study records for 
two years after research has been terminated by the sponsor. They shall take measures to 
prevent accidental or premature destruction of these documents. The investigator may 
transfer custody of records to another person/party and document the transfer at the 
investigation site. 
 Non-Protocol Research 
Elixir Medical has a legal responsibility to comply with regulatory reporting requirements.  
No investigative procedures during the acute period of treatment and follow-up described 
in this protocol shall be undertaken on the enrolled patients without the agreement of Elixir 
Medical. 

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Protocol ELX-CL-1705, Rev C, 18 September 2020 
8.2 
Role of the Sponsor - Elixir Medical  
As the study sponsor of this PMCF study, Elixir Medical has the overall responsibility for 
the conduct of the study, including assurance that the study satisfies international 
regulations and guidelines.4 
 General Duties  
The sponsor is responsible for selecting investigators and establishing agreements. The 
sponsor is also responsible to ensure the study is conducted according to applicable 
MEDDEV and Good Clinical Practice guidelines (GCPs).5 
 Selection and Monitoring of Clinical Sites and Investigators 
Physicians seeking participation should be trained to the hospital procedures for 
angioplasty and coronary stent implantation, the study protocol, and have clinical study 
experience. 
Elixir Medical will select qualified investigators, obtain signed investigator agreements, 
and provide the investigators with the information necessary to conduct the study. Ongoing 
monitoring of each site will be conducted by the sponsor or designee to assure compliance 
with the protocol. 
The sponsor, Elixir Medical, or a designee will monitor the sites either on-site or remotely 
to ensure the ensure that all investigators and procedures are in compliance with the 
protocol and that the completed case report forms match the medical records and resolve 
any differences. 
 Maintaining Records 
Elixir Medical will maintain copies of correspondence, data, adverse device effects and 
other records related to the clinical trial for a minimum of 2 years following completion of 
the study.  Investigative sites will maintain records related to the study in accordance with 
local regulations. 
 Submitting Reports 
Elixir Medical will submit the appropriate reports identified by the regulations.  This 
includes unanticipated adverse device effects, annual progress reports, recall information, 
and final reports. 
                                                 
4 MEDDEV 2.12/2 rev2. Guidelines on medical devices. Post market clinical follow-up studies. A guide for 
manufacturers and notified bodies. January 2012. 
5 ISO 14155:2011, Clinical investigation of medical devices for human subjects - good clinical practice. 
December 2011. 

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 Patient Confidentiality 
The Sponsor will make all efforts to not collect any patient information during this study. 
To maintain patient confidentiality, the use of alpha-numeric identification of patients will 
be used on CRFs.  Further, any publication of study information will not include any 
information that would disclose the patient’s identity. 
 Publication Policies 
At the conclusion of the DESyne X2 PMCF Study, an abstract reporting the primary results 
may be prepared and presented in an appropriate international forum. A manuscript may 
also be prepared for publication in a reputable scientific journal regardless of positive or 
negative results. The publication of the principal results from any single center experience 
within the trial is not allowed until both the preparation and publication of the multi-center 
results as appropriate. All proposed publications and presentations by investigators or their 
personnel resulting from or relating to the study must be submitted to the sponsor for 
review and approval at least 60 days prior to the submission for publication or presentation.  
Elixir Medical will review all materials for proposed publication or presentation for 
accuracy, confidential information, or patentable inventions and the sponsor may delay any 
publication or presentation for a reasonable period of time.  All information and data 
relating to the clinical study, Elixir stents, and other study-related data are the sole property 
of Elixir Medical. 
9.0 
DEFINITIONS 
Acute Success 
Acute success will be classified according to the following categories, which serve as 
comparable "benchmarks" between the similar treatments. 
Device success:  attainment of final result with < 50% residual stenosis of the target 
site, using a DESyne X2 stent and standard pre-dilation catheters 
and post-dilatation catheters (if applicable) 
Physician feedback will be obtained summarizing the following device characteristics: 
• Device preparation  
• Lesion access and cross 
• Stent expansion  
• Delivery system removal  
• Stent crossability for post-dilatation as required 
• Device malfunction assessment 

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Adverse Events and Adverse Device Effects 
The following definitions for adverse events are from EN ISO 14155:2011. 
• Adverse Event 
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 study device. 
• Serious Adverse Event 
An adverse event that led to death, -OR- led to serious 
deterioration in the health of the subject, that resulted in a 
life-threatening illness or injury, or, a permanent impairment 
of a body structure or a body function, or in-patient or 
prolonged hospitalization, or medical surgical intervention 
to prevent life-threatening illness or injury, or, a permanent 
impairment of a body structure or a body function -OR- led 
to fetal distress, fetal death or a congenital anomaly or birth 
defect. 
• Adverse Device Effect 
Adverse event related to the use of the study device. This 
definition includes adverse events resulting from insufficient 
or inadequate instructions for use, deployment, implantation, 
installation, or operation, or any malfunction of the study 
device. This definition also includes any event resulting 
from use error or from intentional misuse of the study 
device. 
• Serious Adverse Device Effect 
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
• Unanticipated Serious Adverse Device Effect 
Serious adverse device effect which by its nature, incidence, 
severity or outcome has not been identified in the current 
version of the risk analysis report. 
Adverse Event Categorization (from EN ISO 14155:2011) 
Adverse 
Event 
Non-device-related 
Device- or procedure-related 
Non-serious Adverse Event (AE) 
Adverse Device Effect (ADE) 
Serious 
Serious Adverse 
Event (SAE) 
Serious Adverse Device Effect (SADE) 
Anticipated 
Unanticipated 
Anticipated Serious Adverse 
Device Effect (ASADE) 
Unanticipated Serious Adverse 
Device Effect (USADE) 

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Angina Pectoris 
• Canadian Cardiovascular Society Classification of Angina: 
1) 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. 
2) 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 2 blocks on the level or climbing 
more than one flight of ordinary stairs at a normal pace and in normal conditions. 
3) Marked limitation of ordinary activity; for example, angina occurs walking 1 or 
2 blocks on the level or climbing one flight of stairs in normal conditions and at a 
normal pace. 
4) Inability to carry on any physical activity without discomfort - angina syndrome 
may be present at rest. 
Bleeding complications 
All transfusions and bleeding complications such as gastrointestinal (GI) bleed, 
hemoglobin drop of >5 g/dl.  Severe bleeding is defined at intracranial bleeding or 
hemorrhage resulting in hemodynamic compromise.  Moderate bleeding is defined as 
bleeding requiring blood transfusion, but without hemodynamic compromise. 
CK and CK-MB 
Creatine kinase and creatine kinase - muscle/brain (an isoenzyme of creatine kinase). 
De novo lesion 
A native coronary artery lesion not previously treated. 
Device Related Procedure Complications 
• Abrupt Closure 
Abrupt (or acute) closure is defined as acute treatment failure in the catheterization 
laboratory, in which persistent reduced flow requires rescue by another device or 
emergency surgery in order to prevent myocardial injury.  The occurrence of 
transient closure or "no reflow," in which further stent or balloon use restores 
normal flow and a patent (<50% residual stenosis) lumen, is occasionally seen and 
does not represent abrupt closure.  Abrupt closure will thus be reserved for the 
occurrence of reduced flow (TIMI grade 0 or 1), due to mechanical dissection, 
coronary thrombus, or severe microvascular spasm, that results in:  1) repeat 
treatment not allowable in the assigned treatment arm, 2) emergent surgery, 3) 
myocardial infarction, or 4) death. 
• Dissection 
Dissection is defined as defects that occur during the stent implant procedure that 
cannot be treated during the procedure to obtain an optimal outcome. Dissection 

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will be graded according to NHLBI Grades: A: intraluminal radiolucent defect; 
B: extraluminal cap without staining; C: extraluminal cap with persistence of dye 
(staining); D: spiral defects; E: persistent filling defect; and F: filling defect with 
total occlusion. 
Optimal treatment of lesion/vessel 
Optimal lesion/vessel treatment is defined as: 
• < 20% residual stenosis by visual assessment  
• no evidence of dissection  
• no evidence of thrombus in the target lesion or vessel 
• TIMI 3 flow 
Ostial lesion 
Lesion involving the origin of the coronary artery within the first 3 mm. 
Restenotic lesion 
A lesion in a vessel segment that has undergone prior percutaneous treatment. 
Target Lesion 
The target lesion is the treated lesion starting 5 mm proximal of the stented lesion and 
ending 5 mm distal beyond the stented lesion. 
Target Vessel 
The target vessel is the entire major coronary vessel proximal and distal to the target lesion 
including upstream and downstream branches and the target lesion itself. 
TIMI flow grades  
1.  No contrast flow through the stenosis. 
2.  A small amount of contrast flows through the stenosis but fails to fully opacify the 
artery beyond. 
3.  Contrast material flows through the stenosis to opacify the terminal artery segment.  
However, contrast enters the terminal segment perceptibly more slowly than more 
proximal segments.  Alternatively, contrast material clears from a segment distal to a 
stenosis noticeably more slowly than from a comparable segment not preceded by a 
significant stenosis. 
4.  Anterograde flow into the terminal coronary artery segment through a stenosis is as 
prompt as anterograde flow into a comparable segment proximal to the stenosis.  
Contrast material clears as rapidly from the distal segment as from an uninvolved, more 
proximal segment.  

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10.0 
 Appendix I:  Sample Patient Informed Consent     
A NON-RANDOMIZED, POST MARKETING CLINICAL FOLLOW-UP (PMCF) 
STUDY OF THE DESyne® X2 NOVOLIMUS ELUTING CORONARY STENT 
SYSTEM IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE 
CORONARY ARTERY LESIONS 
 
“DESyne X2 PMCF Study” 
ELX-CL-1705 
Background 
Your physician has determined that one of your coronary arteries has a significant narrowing that 
is causing decreased blood flow to your heart muscle.  There are two methods commonly used to 
correct this problem.  The first is balloon angioplasty usually followed by the placement of a stent.  
Balloon angioplasty does not leave a permanent device in the artery after the balloon catheter is 
removed.  Stent placement means that the small metal scaffold (stent), some containing a small 
amount of drug (drug-eluting stent – DES), is left behind after the balloon is removed and the stent 
becomes a permanent part of your artery.  Stents have been used for many years to treat narrowing 
in both coronary arteries and bypass grafts (saphenous vein grafts). 
 
Purpose and Procedures 
The purpose of this study is to confirm the acute (during the implant procedure) safety and 
effectiveness of the CE Mark approved DESyne® X2 Novolimus Eluting Coronary Stent System.  
Patients deemed by their physician to be eligible for this study will be enrolled.  Your physician has 
described the stent procedure to you during which the CE Mark approved and commercially 
available DESyne X2 stent will be used.  This stent system is similar to other market approved 
stents and is implanted using the same technique.  Implantation procedure information will be 
collected during this study and you will be closely observed by medical staff during your procedure. 
 
The DESyne X2 Stent System incorporates the drug Novolimus and is similar to sirolimus, 
everolimus and zotarolimus, which are drugs currently approved for use on drug eluting stents.  The 
dose of the drug on the stent is approximately 5.0 mcg of drug per mm of stent length (80 mcg for 
an 18 mm stent) and similar to or less than the dose on other drug eluting stents.  The DESyne X2 
stent is covered by a thin coating called a polymer that holds the drug and which allows the release 
of the drug over a known period of time.  The research staff will be able to answer any questions 
you have concerning the stent system or about the study itself. 
 
As with any stent procedure, you will be required to take routine medications, intended to help 
prevent your blood from clotting. These routine medications may include clopidogrel, prasugrel, 
or ticagrelor, and aspirin for at least one year.  Please do not stop taking the medications without 
first getting approval from your doctor.  It is very important that you take this medication 
everyday as your doctor has prescribed. 
 

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Potential Risks 
The drug used on the stent is in such a low dose there is little potential to cause side effects.  
However, if you experience any signs of an allergic reaction such as rash, itching or swelling, 
inform your physician immediately.  Previous stent implantation studies involving the use of 
clopidogrel have shown a 1 to 2% chance of blood clotting within the stent. As with any stent 
implantation procedure, if clotting of the stent does occur, it may lead to repeat 
catheterization/angioplasty, myocardial infarction (heart attack), urgent bypass surgery, or death. 
 
Furthermore, even with successful initial implantation, there is still a chance of the treated area re-
narrowing usually occurring within the first 4 to 9 months.  This may require additional therapy, 
such as repeat angioplasty, stenting, and/or bypass surgery to provide adequate blood flow to the 
heart muscle jeopardized by the re-narrowing.  This treatment may involve some other risks to you, 
the nature of which is unknown. 
 
Potential Benefits 
The use of drug eluting coronary stents has shown the potential to reduce the incidence of re-
narrowing in the artery at the treated site. 
 
Confidentiality 
Your physician and the study sponsor will maintain your confidentiality during your participation 
in this study.  You will not be identified by name, tax identification number, address, telephone 
number, or any other direct personal identifier in study records.  However, copies of your 
angiography which may contain your full name, may be sent to an independent reviewer for 
analysis.  When results of a study such as this are reported in medical journals, symposia, 
or www.clinicaltrials.gov website, the identification of patients is withheld.  Medical records of 
participants are maintained according to current legal requirements and will be made available for 
review to the appropriate Regulatory Authorities, the study sponsor or its representatives. 
 
Policy Regarding Research-Related Injuries 
In the event of injury resulting from your participation in this research there will be no monetary 
compensation or subsidized medical treatment for this injury provided to you by the study sponsor, 
(Name of the Institution) or any person involved in this research project. 
 
Pregnancy (risk to fetus) 
Pregnant or nursing women as well as women of childbearing potential, or those who do not agree 
to contraception for at least one year following stent implant, are excluded from this study as there 
is inadequate information about the long-term effect of this drug on pregnant women.  There is no 
evidence of effect on fertility in males, however the effect of the drug on human sperm is not 
known. 
   
Alternative Treatment(s) 
There are alternative methods available to treat the narrowing in your coronary artery. These 
include; conventional balloon angioplasty; atherectomy, whereby a cutting device is used to remove 

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the material causing the narrowing; stent implantation with a different bare metal or drug eluting 
stent or, coronary artery bypass graft (CABG) surgery. 
 
Problems or Questions 
Your doctor has the right to terminate this study or your individual participation at any point. Should 
any problem or question arise with regard to this study, with regard to your rights as a participant 
in clinical research or with regard to any research-related injury, you may contact the Principal 
Investigator. 
 
Physician Name: ________________________________________   
 
Telephone number: ________________________________________   
 
Your family physician will be advised of your participation in this trial. You should inform your 
physician if you sustain any injury during the course of this study or are admitted to a hospital. 
 
It is suggested that you retain a copy of this document for your later reference and personal records. 

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Protocol ELX-CL-1705, Rev C, 18 September 2020 
INFORMED CONSENT 
“DESyne X2 PMCF Study” 
ELX-CL-1705 
You are being invited to take part in a research study involving approximately 100 patients who 
will be enrolled at this site and others in Europe and other international locations. It is important 
that you understand several facts that apply to patients participating in clinical studies: 
a. Taking part in the study is voluntary; 
b. You may or may not receive personal benefits from taking part in the study, but 
knowledge may be gained from your participation that will benefit others; 
c. You may withdraw from the study at any time without penalty or loss of any 
benefits to which you are otherwise entitled;  
d. Significant new findings discovered during the course of this study, which may 
affect your willingness to continue participating in this study, will be provided to 
you. 
During your treatment for coronary artery disease, you will receive one or more DESyne® X2 
Novolimus Eluting Coronary Stent.  This stent has CE Mark approval.  The purpose of this study 
is to provide an acute (during the procedure) evaluation of the safety and performance of the stent.  
The research staff will have your permission to review your medical records during your 
hospitalization.  
Your physician and the study sponsor will assure that your participation in this study is confidential. 
You will not be identified by name, social security number, medical record number, or any other 
direct personal identifier in the study records. 
You will not receive additional charges for participation in this study nor will you receive any 
payment for participation in this study.  
You understand that there are no known additional risks involved in your participation in this study 
which exceed the risks outlined in the consent you have already provided for interventional 
coronary treatment.  You are urged to discuss any questions you have about this study with 
staff members. If you need to talk to someone about your experiences at [hospital name], you can 
call [research coordinator name] at [phone number] or your doctor at [phone number]. You may 
also contact the Ethics Committee Chairman at any time during the study if you have questions or 
concerns at [phone number]. 
By signing below, I voluntary agree to participate in the study and will comply with the directions 
provided by the research staff. 
Participant’s 
signature: 
 
 
Date 
 
 
Printed 
name: 
 
 
 
 
 
I have explained and defined in detail the research procedure in which the participant has agreed to 
participate, and have made a copy of this informed consent form available for the patient. 

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Consent 
obtained 
by: 
 (signature)  
 
Date 
 
 
 
(printed 
name) 
  
Title