A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data of POLYTHESE® Vascular Prostheses
Conditions: Aneurysm Arterial, Peripheral Arterial Disease, Marfan Syndrome, Arterial Dissections, Ehlers-Danlos Syndrome
Sponsor: Perouse Medical

 
PROTOCOL 
TITLE: 
2021-PT-01  
Safety and Performance of POLYTHESE® vascular prosthesis 
EFFECTIVE DATE: 
1 July 2021 
 
 
 
 
Version: 1 
CONFIDENTIAL, PRINTED COPIES FOR REFERENCE ONLY 
Page 1/29 
 
A Retrospective, Observational, Multicenter, Study 
to Collect Clinical Safety and Performance data of 
POLYTHESE® vascular prostheses 
- Protocol 2021-PT-01 
Version 1 
 
Author 
 
Location 
Valerie LONGIN 
Clinical Trial Operations 
 
 
 
 
 
 
 
ECLEVAR 
Tour Europlaza 
20 avenue André Prothin 
92927 La Défense Cedex 
Mikaela DIMITRIU 
Head of RW solutions 
 
 
 
 
 
 
 
ECLEVAR 
Tour Europlaza 
20 avenue André Prothin 
92927 La Défense Cedex 
Verifiers 
 
Location 
Pascal CHABE 
R&D manager 
 
 
 
 
 
 
 
PEROUSE MEDICAL 
Route du Manoir 
60173 IVRY-LE-TEMPLE 
Laura JULIEN 
Principal Regulatory Affairs Manager  
 
 
 
 
 
 
 
PEROUSE MEDICAL 
Route du Manoir 
60173 IVRY-LE-TEMPLE 
Approvers 
 
Location 
Agnès JORDAN 
Regulatory Affairs DIRECTOR 
 
 
PEROUSE MEDICAL 
Route du Manoir 
60173 IVRY-LE-TEMPLE 

 
PROTOCOL 
TITLE: 
2021-PT-01  
Safety and Performance of POLYTHESE® vascular prosthesis 
EFFECTIVE DATE: 
1 July 2021 
 
 
 
 
Version: 1 
CONFIDENTIAL, PRINTED COPIES FOR REFERENCE ONLY 
Page 2/29 
 
 
Study Product Name:  
POLYTHESE® vascular prostheses 
Sponsor/manufacturer:    
PEROUSE Medical 
 
 
 
 
Route du Manoir, 
60173 Ivry-le-Temple 
France 
Participating sites: 
 
To be detailed in separate document 
 
 

 
PROTOCOL 
TITLE: 
2021-PT-01  
Safety and Performance of POLYTHESE® vascular prosthesis 
EFFECTIVE DATE: 
1 July 2021 
 
 
 
 
Version: 1 
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CONTENTS 
 
1. 
List of Abbreviations ....................................................................................................................... 5 
2. 
Synopsis .......................................................................................................................................... 6 
3. 
Introduction. ................................................................................................................................... 8 
4. 
Study device .................................................................................................................................... 9 
4.1. 
Summary description of the device ....................................................................................... 9 
4.2. 
Intended purpose and patient population .......................................................................... 10 
4.2.1. 
Intended clinical purpose ................................................................................................ 10 
4.2.2. 
Patient population characteristics .................................................................................. 10 
4.3. 
Contra-indications ............................................................................................................... 13 
5. 
Study design .................................................................................................................................. 13 
5.1. 
Summary of relevant Clinical data ....................................................................................... 13 
5.2. 
Rationale for PMCF study .................................................................................................... 17 
5.3. 
Subjects ............................................................................................................................... 17 
5.3.1. 
Inclusion criteria .............................................................................................................. 17 
5.3.2. 
Exclusion criteria ............................................................................................................. 17 
6. 
Risks and benefits of the device ................................................................................................... 17 
6.1. 
Anticipated clinical benefits ................................................................................................ 17 
6.2. 
Anticipated risks .................................................................................................................. 18 
7. 
Objectives and Endpoints ............................................................................................................. 19 
7.1. 
Performance endpoints ....................................................................................................... 19 
7.2. 
Safety endpoints .................................................................................................................. 20 
8. 
Statistical considerations .............................................................................................................. 20 
8.1. 
Statistical design, method and analytical procedures ......................................................... 20 
8.1. 
Sample size justification ...................................................................................................... 21 
9. 
Data management ........................................................................................................................ 21 
9.1. 
Data sources ........................................................................................................................ 21 
9.2. 
Data to collect ..................................................................................................................... 22 
9.3. 
Data consistency .................................................................................................................. 24 
9.4. 
Missing data ........................................................................................................................ 24 
9.5. 
Database structuration ........................................................................................................ 24 
10. 
Adverse events DEFINITIONS ................................................................................................... 24 

 
PROTOCOL 
TITLE: 
2021-PT-01  
Safety and Performance of POLYTHESE® vascular prosthesis 
EFFECTIVE DATE: 
1 July 2021 
 
 
 
 
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11. 
SAFETY REPORTING PROCEDURES ........................................................................................... 24 
12. 
REGULATORY CONSIDERATIONS .............................................................................................. 25 
13. 
Informed Consent Process ....................................................................................................... 25 
14. 
monitorING of the study .......................................................................................................... 25 
15. 
Confidentiality of the study ..................................................................................................... 25 
16. 
Publication policy ..................................................................................................................... 25 
16.1. 
Multicentre Publication ....................................................................................................... 25 
16.2. 
Publication ........................................................................................................................... 26 
17. 
Clinical Study Report ................................................................................................................ 26 
18. 
Bibliography ............................................................................................................................. 26 
19. 
Appendix .................................................................................................................................. 28 
 
 
 

 
PROTOCOL 
TITLE: 
2021-PT-01  
Safety and Performance of POLYTHESE® vascular prosthesis 
EFFECTIVE DATE: 
1 July 2021 
 
 
 
 
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1. LIST OF ABBREVIATIONS 
AAA 
 
Abdominal aortic aneurysm 
IAA 
 
Ilia arterial aneurysms 
FAA                     Femoral arterial aneurysms 
PAA                     Popliteal arterial aneurysms 
ADE 
 
Adverse Device Effect  
AE 
 
Adverse Event 
ABI 
 
Ankle Brachial Index 
AD 
 
Aortic Dissection 
CLTI  
 
Chronic limb-threatening ischemia  
MI 
 
Myocardial Infarction 
PAD 
 
Peripheral arterial disease 
PMCF   
Post-Market Clinical Follow-up 
SADE   
Serious Adverse Device Effect  
TASC   
Trans-Atlantic Inter-Society Consensus 
USADE   
Unanticipated Serious Adverse Device Effect   
aTAA 
 
 Ascending Thoracic aortic Aneurysm 
dTAA    
Descending Thoracic Aortic Aneurysm 
 
 

 
PROTOCOL 
TITLE: 
2021-PT-01  
Safety and Performance of POLYTHESE® vascular prosthesis 
EFFECTIVE DATE: 
1 July 2021 
 
 
 
 
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2. SYNOPSIS 
Title: 
A Retrospective, Observational, Multicenter, Study to Collect 
Clinical Safety and Performance data on POLYTHESE® vascular 
prostheses 
Study Population : 
Subjects who did receive POLYTHESE® at least one year ago for 
replacement or bypass of pathological arteries. 3 main sub-
populations will be studied depending on location of surgery 
(thoracic or abdominal and peripheral), but data will be collected 
for all subjects who did receive POLYTHESE® vascular prosthesis. 
Study Design: 
Multi-center retrospective case series  
Study Type: 
PMCF 
Number of subjects: 
Data from a minimum of 300 subjects will be evaluated. A 
minimum of 200 subjects will be evaluated for thoracic location 
of surgery. 
Follow-up 
At least 1-year follow-up after surgery until a maximum of 5 years. 
Study Product: 
Any POLYTHESE® vascular prosthesis of following ranges: 
- 
POLYTHESE® IC  
- 
POLYTHESE® ICT 
- 
POLYTHESE® IC-3GL 
 
Intended use: 
POLYTHESE® vascular prostheses are indicated for replacement 
or bypass of arteries presenting aneurysm or arterial disease. 
Their indication is restricted to thoracic, abdominal and 
peripheral surgery not involving the crossing of the knee flexion 
crease. 
Objectives: 
• 
Describing 
safety 
and 
performance 
of 
POLYTHESE® 
throughout its expected lifetime 
Performance primary 
endpoint: 
Primary patency rate at 1 year after surgery using 
POLYTHESE® 
 
Safety Primary endpoints:  
• 
Mortality rate at 30 days after surgery using POLYTHESE® 
Performance secondary 
endpoints: 
• 
Procedural success rate  
• 
Primary patency rate at 30 days and 6 months after surgery 
using POLYTHESE® 
• 
Primary assisted patency rate at 30 days, 6 months and 1 year 
after surgery using POLYTHESE® 
• 
Secondary patency rate at 30 days, 6 months and 1 year after 
surgery using POLYTHESE® 

 
PROTOCOL 
TITLE: 
2021-PT-01  
Safety and Performance of POLYTHESE® vascular prosthesis 
EFFECTIVE DATE: 
1 July 2021 
 
 
 
 
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• 
Device failure during procedure or at discharge, at 30 days, 6 
months and 1 year after surgery using POLYTHESE® 
Safety secondary endpoints 
• 
Mortality rate during procedure or at discharge, at 6 months 
and 1 year after surgery using POLYTHESE®  
• 
Limb salvage rate at 30 days, 6 months and 1 year after 
surgery using POLYTHESE®  
• 
Adverse event during procedure or at discharge, at 30 days, 6 
months and 1 year after surgery using POLYTHESE® 
Exploratory endpoints 
• 
After 1 year until the end of follow-up (5 years) using 
POLYTHESE®:  
o Primary patency  
o Primary assisted patency  
o Secondary patency  
o Device failure  
o Mortality  
o Limb salvage 
o Adverse events  
o Identify possible systematic misuse or off-label use of 
POLYTHESE®, with a view to verifying that the 
intended clinical purpose is correct. 
Inclusion criteria 
Subjects who did receive POLYTHESE® (IC, ICT, IC-3GL) at least one 
year ago for replacement or bypass of arteries presenting 
aneurysm or arterial disease 
Exclusion criteria 
Patients who have objected to the collect of their data 
Duration of the data collect: 
6 months from first site operational to collect data until data 
delivery 
Data to be collected (as far as 
available) 
• 
Identification and demographic data  
o Patient characteristics 
o Indication and location of surgery   
o Patients demographics and risk factors  
o Summary of previous cardiovascular 
interventions  
o Relevant medications 
o Diagnosis  
• 
Operative data  
o Date of procedure  

 
PROTOCOL 
TITLE: 
2021-PT-01  
Safety and Performance of POLYTHESE® vascular prosthesis 
EFFECTIVE DATE: 
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o Identification data for the prosthesis  
o Information related to the surgical procedure 
o Relevant medication  
o Assessment of prosthesis function and mode of 
assessment if available  
o Device failure modes and documented adverse 
operative events 
• 
Post-operative data (follow-up) 
o Date of follow-up visits 
o Summary of vascular interventions, including 
minimally invasive procedures 
o Clinical evaluation 
o Relevant medications  
o Device failure modes and documented adverse 
events  
• 
Any documented adverse events data (as far as 
available) 
o Type of event, date of occurrence, severity, 
management, outcome  
o Any Documentation of probable causative factors 
(e.g. caused by the prosthesis, patient factors, 
technical factors)  
Timepoints of collected data 
- 
During procedure and at discharge (7-14 days) 
- 
30-days after surgery (‘peri-operative’) 
- 
6, 12 months 
- 
Annually up to 5 years post procedure   
 
3. INTRODUCTION.  
POLYTHESE® IC and ICT devices are CE-marked and were initially introduced in the international market 
in 1997, followed in 2003 and 2005 respectively by POLYTHESE® and POLYTHESE® devices. POLYTHESE® 
IC-3GL devices were then introduced in 2009. 
Since January 2002, more than 60 000 single devices have been sold across various markets worldwide.
 
 

 
PROTOCOL 
TITLE: 
2021-PT-01  
Safety and Performance of POLYTHESE® vascular prosthesis 
EFFECTIVE DATE: 
1 July 2021 
 
 
 
 
Version: 1 
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4. STUDY DEVICE 
The studied device is POLYTHESE®, which consists in uniform straight or bifurcated tubular synthetic 
textile coated vascular grafts.  
POLYTHESE® vascular prostheses are made by weaving of polyethylene terephthalate (PET – polyester) 
yarns and impregnated with collagen CXE® coating of bovine origin.   
CXE® collagen impregnation of the POLYTHESE® vascular prostheses ensure water permeability of less 
than 10 ml/cm2/min at a pressure of 120 mm of mercury (Hg) and allows direct implantation of the 
prosthesis without the need for pre-clotting. 
4.1. Summary description of the device  
The POLYTHESE® vascular prostheses are divided into 3 different ranges according to their 
configuration: 
• 
POLYTHESE® IC 
POLYTHESE® IC are straight tubes or bifurcated prostheses (Figure 1), with nominal diameters 
ranging from 6 to 28 mm, and usable length from 15cm to 100 cm.  
• 
POLYTHESE® ICT  
POLYTHESE® ICT are straight tubes with two equidistant longitudinal black guidelines over the entire 
length (Figure 1), with nominal diameters ranging from 30 to 38 mm, and usable length from 15cm to 
60 cm. 
• 
POLYTHESE® IC-3GL 
POLYTHESE® IC-3GL are straight tubes with three equidistant longitudinal black guidelines over the 
entire length (Figure 1), with nominal diameters ranging from 20 to 38 mm, and usable length from 
15cm to 60 cm. 
A wide range of dimensions / references is available for each device listed in Appendix. 
 
 
 
Straight POLYTHESE® IC/ICT 
Bifurcated POLYTHESE® IC 
POLYTHESE® IC-3GL 
Figure 1: POLYTHESE® IC/ICT and POLYTHESE® IC-3GL vascular grafts 
 

 
PROTOCOL 
TITLE: 
2021-PT-01  
Safety and Performance of POLYTHESE® vascular prosthesis 
EFFECTIVE DATE: 
1 July 2021 
 
 
 
 
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4.2. Intended purpose and patient population 
4.2.1. Intended clinical purpose  
POLYTHESE® IC, ICT and IC-3GL vascular prostheses ranges are indicated for replacement or bypass of 
arteries presenting aneurysm or arterial disease. Their indication is restricted to thoracic (POLYTHESE® 
ICT), abdominal and peripheral surgery not crossing the knee flexion crease. 
POLYTHESE® IC-3GL prostheses are especially indicated in aortic root and ascending thoracic aorta 
surgery. 
4.2.2. Patient population characteristics  
Patient population conditions that may indicate abdominal, thoracic and/or peripheral vascular open 
surgical repair with implantation of a vascular graft include:  
• 
Peripheral arterial diseases (PAD), characterized by reduced blood flow to the lower 
extremities, which may be categorized as: 
- 
Intermittent claudication (IC)  
- 
Chronic limb-threatening ischemia (CLTI) 
- 
Acute limb ischemia (ALI) 
- 
Chronic total occlusion (CTO) 
• 
Arterial aneurysms, characterized by a permanent localized (i.e., focal) dilatation having at 
least a 50% increase in diameter, which may be categorized by location:  
- 
Thoracic aortic aneurysm (TAA) 
§ 
Ascending thoracic aortic aneurysm  
§ 
Aortic arch thoracic aortic aneurysm  
§ 
Descending thoracic aortic aneurysm 
§ 
Thoraco-abdominal aortic aneurysm  
- 
Thoracic aortic aneurysms  
§ 
Ascending aorta  
§ 
Descending thoracic aorta  
- 
Abdominal aortic aneurysms (AAA)  
- 
Peripheral arterial aneurysms  
§ 
Ilia arterial aneurysms (IAA)  
§ 
Femoral arterial aneurysms (FAA)  
§ 
Popliteal arterial aneurysms (PAA) 
• 
Arterial dissections are classified according to the location of the entry intimal tear and the 
extent of aorta involved in the dissection:  
- 
Stanford type A dissection  
§ 
Type I Dissection (originates in the ascending aorta, extends through the aortic 
arch, and continues into the descending aorta and/or abdominal aorta). 
§ 
Type II Dissection (originates in and is confined to the ascending aorta) 

 
PROTOCOL 
TITLE: 
2021-PT-01  
Safety and Performance of POLYTHESE® vascular prosthesis 
EFFECTIVE DATE: 
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- 
Stanford type B dissection  
§ 
Type IIIa Dissection (originates in the descending aorta and is limited to same) 
§ 
Type IIIb Dissection (involves descending and variable extents of the 
abdominal aorta) 
• 
Connective tissues abnormalities such as in Marfan Syndrome, Ehler-Danlos Syndrome, 
annulo-ecstasia disease, hereditary dysplasia, conjunctival elastic and media dystrophies 
4.2.2.1. 
Peripheral arterial diseases (PAD)  
Reported PAD risks factors are:  
• 
History of cardiovascular disease  
• 
Smoking  
• 
Diabetes mellitus  
• 
Hypertension  
• 
Dyslipidemia 
• 
Obesity  
• 
Age  
Age is the strongest risk factor for PAD. The disease is rare in individuals younger than 40 years, rises 
in prevalence in the sixth to eighth decades, and may affect 25% or more of individuals 80 years and 
older. 
4.2.2.2. 
Arterial aneurysms  
Reported arterial aneurysms risks factors are:  
• 
advanced age,  
• 
gender,  
• 
smoking,  
• 
family history,  
• 
obesity,  
• 
hypertension, 
• 
co-morbidities such as coronary heart disease, diabetes, atherosclerosis.  
Although abdominal aortic aneurysms (AAAs) and ascending aortic aneurysms are more common, 
descending thoracic aortic aneurysms (TAAs) and thoracoabdominal aortic aneurysms (TAAAs) are not 
rare, with an estimated incidence of around 10 cases per 100,000 person-years.  
TAAAs are primarily a disease of the elderly. The average age of patients with TAAAs is 65 years, with 
a male-female ratio of 1.7 : 1. TAAAs clearly have a genetic component, since more than 20% of 
patients will have a first-degree relative affected by aneurysm disease.  
Aneurysms involving the aortic arch account for about 10% of the total cases of thoracic aorta 
aneurysms. 

 
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Safety and Performance of POLYTHESE® vascular prosthesis 
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Prevalence of abdominal aortic aneurysms (AAA) 4 cm or larger is approximately 1% of men between 
the ages of 55 and 64 years and increases with advancing age by 2% to 4% by decade. Emergence of 
AAAs rises sharply in individuals aged ≥60 years old. It has also been consistently demonstrated that 
AAAs occur with greater frequency in men, smokers, and those with a family history of aortic 
aneurysm.  
Data on prevalence of AAA varies between 1.3% and 12.5% in males, and between 0.0% and 5.2% in 
females. Overall prevalence varies from 4 to 8%.  
Iliac artery aneurysms (IAAs) commonly occur concurrently with other more proximal arterial 
aneurysms. In contrast to generalized aorto-iliac aneurysms, isolated iliac aneurysms are prevalent in 
≤ 2% of the general population. 
Femoral artery true aneurysms are found predominantly in older men (70 years or older) and are 
associated with smoking and hypertension.  
Popliteal artery aneurysms are rare in the general populations, although they are the most common 
peripheral artery aneurysms (70% of them). PAAs are exclusively found in men. A prevalence of around 
1% in men has been reported in UK between 65 and 85 years. 
4.2.2.3. 
Aortic dissections 
Factors that predispose one to develop aortic dissection include: 
• 
age,  
• 
hypertension,  
• 
structural abnormalities of the aortic wall 
Incidence of acute aortic dissection ranges from 2 to 4 per 100,000 person-years. The incidence of type 
A dissection peaks between 50 and 60 years, while type B dissections occur more frequently between 
60 and 70 years of age.  
4.2.2.4. 
Connective tissue abnormalities including Marfan syndrome, Ehler-Danlos 
Syndrome, conjunctival elastic and media disorders 
A connective tissue disease is a genetic disease in which the primary target is either collagen or elastin 
protein assembly, disruption of which leads to an inherent predisposition to degeneration, loss of 
structural integrity, and consequent aneurysm formation or spontaneous vascular dissection and 
rupture. These connective tissue abnormalities have severe vascular manifestations, and most 
commonly include Marfan syndrome (MFS), the vascular type of Ehlers-Danlos syndrome (EDS IV), 
Loeys-Dietz syndrome (LDS), and familial thoracic aortic aneurysm and dissection.  
The vascular manifestations of Marfan syndrome invariably involve aortic root dilation, progressive 
root and ascending aortic aneurysmal degeneration, and potentially aortic dissection of variable 
extent. The incidence of Marfan syndrome (MFS) is about 2 to 3 per 10,000 individuals, with no 
gender predisposition. This genetic disorder is a dominant Mendelian trait in 75% of cases.  
The prevalence of Ehler-Danlos Syndrom (EDS), with type III procollagen disorder, is currently 
estimated to be 1 in 50,000 to 90,000. Major complications in childhood are rare, even if 25% of the 

 
PROTOCOL 
TITLE: 
2021-PT-01  
Safety and Performance of POLYTHESE® vascular prosthesis 
EFFECTIVE DATE: 
1 July 2021 
 
 
 
 
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subjects may present medical or surgical complications by the age of 20. By 40 years of age, major 
complications in the vascular or gastrointestinal systems or reproductive system (women) had 
developed in around 90 %.  
4.3. Contra-indications 
The use of any model of POLYTHESE® vascular prostheses is contra-indicated for:  
• 
Coronary bypasses 
• 
Patients with hypersensitivity to collagen 
5. STUDY DESIGN  
POLYTHESE® study is a retrospective, observational, multicentre, case series which examine short and 
long-term outcomes of using POLYTHESE®. This study will be done on Real World Data to describe the 
safety and performance of the device. 
5.1. Summary of relevant Clinical data  
Relevant clinical data on POLYTHESE® vascular prostheses consist in: 
• 
1 prospective randomized clinical trial (published data): Tofigh 2007 (52 patients)  
• 
1 prospective comparative non-randomized study (published data): Benetis 2014 (7 patients)  
• 
1 clinical non-comparative study (published data): Kaplan 2015 (12 patients) 
• 
1 multicenter retrospective study (unpublished data): Fabiani & Maiza 1996 (51 patients)  
• 
7 case reports (published data) – 15 patients:  
o Touati 2003 (n=6),  
o Colak 2012 (n=1),  
o Martens 2013 (n=1),  
o Baydar 2013 (n=1),  
o Yazici 2012 (n=1),  
o Alexoiu 2014 (n=1),  
o Kollias 2014 (n=4).  
Prospective randomized clinical trial (published data) 
A prospective randomized Clinical trial [Tofigh 2007] was performed to compare the outcome of the 
use of reversed saphenous vein and collagen impregnated woven polyester prosthesis. In a 3-year 
period, 103 above-knee femoropopliteal bypass graft operations were performed and followed in 85 
patients (52 males, 33 female). The indication for operation was severe claudication in 74 cases, rest 
pain in 7 cases, and ulceration in 4 cases. For the bypass graft, a reversed saphenous vein was used in 
each of 51 cases, and a collagen impregnated woven polyester prosthesis was used in each of 52 cases. 
Preoperative risk factors were diabetes (24%), a history of myocardial infarction (23%), and current 
status with respect to smoking (74%). On a total of 85 patients, 103 operations were performed, 51 of 

 
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Safety and Performance of POLYTHESE® vascular prosthesis 
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which used reversed vein and 52 of which used 6-mm POLYTHESE® IC collagen prosthesis. When 
collagen prosthesis was used, operating time was shorter than vein bypass graft (73±9.1 minutes vs. 
105±8.8 minutes, p=0.002). Two cases with collagen prosthesis had superficial wound infection which 
did not require reoperation and result in graft loss. None of the patients who had collagen prosthesis 
were lost to follow-up. Primary patency rates of collagen prosthesis vs. vein bypass graft were 67% vs. 
81% (p=0.065) at 2-year. After reintervention, the secondary patency rates of autogenous grafts vs 
collagen prosthesis were 81% vs. 77% (p=0.298) at 3-year. The difference between collagen prosthesis 
and bypass graft in terms of patency rates were not statistically significant due to short follow-up time 
and longer time is required to see a significant difference. Nevertheless, results suggest that collagen 
prosthesis can be safely used for femoropopliteal bypass grafting. 
Prospective non-randomized single-centre study (published data)  
A prospective non-randomized single-centre study [Benetis 2014] was performed to compare the 
outcome of stent and surgery in terms of treatment success. Of 316 patients who underwent 
angiography, 101 consecutive patients treated for TASC II type B, C, and D iliac lesions were divided 
into two groups: (i) 54 patients (stent group) who underwent iliac endovascular procedures and (ii) 47 
patients (surgery group) who underwent direct aortoiliac bypass reconstructions. All patients were 
followed up to assess the early, 1-year and 2-year stent and graft patency. Patients who underwent 
direct aortoiliac bypass reconstruction underwent either bilateral (n=7) or unilateral bypass (n=40) 
reconstruction, and collagen coated POLYTHESE® IC prostheses were used for bilateral 
reconstructions. Overall, 1- and 2-year prosthetic graft patencies were 97.1±2.9% and 97.1±2.9%, 
respectively. No perioperative mortality was observed in either of the groups. In the surgery group, 2 
patients were lost to myocardial infarction (MI), one after 14 months and the other after 19 months 
following the surgery. Assisted primary patency rates of the surgery group were higher than the stent 
group. Complication rate was 7.4% in the stent group whereas it was 6.3% in the surgery group, which 
included pneumonia, wound complications and inguinal lymphorrhoea. Neither graft infection nor 
early mortality were observed in the surgery group, although this was attributed to the small number 
of patients undergoing above-knee femoropopliteal bypass procedures (n=7). In conclusion, both stent 
and grafting were found to be safe procedures for patients with severe aortoiliac occlusive disease. 
Clinical non-comparative study 
Kaplan et al. (2015) conducted a clinical non-comparative study with the aim to report the outcomes 
of patients who underwent proximal thoracic aortic aneurysm surgery with open distal anastomosis 
technique but without cerebral perfusion, instead under deep hypothermic circulatory arrest. A total 
of 30 patients (21 male, 9 female) with an average age was 60.2 ± 11.7 years (range, 30-74 years), with 
ascending aorta aneurysm associated with aortic valvular disease, coronary artery disease, or mitral 
valve disease were included. During this study, 12 patients were implanted with POLYTHESE® for 
proximal thoracic aortic aneurysm repair (other types of grafts were implanted).  
There was one hospital death (3.3%) due to chronic obstructive pulmonary disease at postoperative 
day 22. No neurological dysfunction was observed during the postoperative period. Revision was 
required in 3 patients due to bleeding (10%) and wound side revision was required in another 2 (6.6%). 
Four patients had postoperative atrial fibrillation (13.3%) and sinus rhythm was reestablished with 
medical treatment in all patients.  

 
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Safety and Performance of POLYTHESE® vascular prosthesis 
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Multicenter retrospective study (unpublished data) 
A multicenter retrospective study was conducted (unpublished data) with the aim to report clinical 
and ultrasound results on the use of the POLYTHESE® IC Prosthesis in the treatment of infra-renal aortic 
lesions. Between 1993 and 1994, 26 patients (22 men and 5 women) were operated at Pr. Fabiani’s 
unit (Centre 01) and 25 patients (22 men and 3 women) were operated at Caen Hospital (Pr. Maiza’s 
unit, Centre 02). A total of 51 patients with infra-aortic lesions were included in the study, with an 
average age of 71 years in Centre 01, and 66 years in Centre 02. Overall, 41 cases of aneurysms, mostly 
aorto-iliac and infra renal aortic aneurysms, were operated during the study, in addition to 15 cases of 
occlusion / stenosis of femoral, iliac artery and the aortic bifurcation. Among the implanted prostheses, 
41% of POLYTHESE® Grafts were tubular graft, mostly 20mmØ (11 cases) and 18mmØ (5 cases), and 
59% were bifurcated grafts, mostly 16mmØ (8 cases) and 18mmØ (8 cases). Of note, length of 
prostheses was not measured per-operatively.  
Postoperative permeability and stability were controlled by Doppler Ultrasound almost one year after 
implantation. Analysis of the Echo-Doppler results concluded that the one-year patency rate was 
99.7%. Permeability of the prostheses was satisfactory.  
Regarding safety, no death cases were associated to the prosthesis. Nonetheless, one patient 
developed a perioperative acute pulmonary oedema on day 2 with shock associated with ischemic 
heart disease and deterioration of renal failure requiring dialysis. Immediate post-operative 
complications were a bleeding case from the suture site, a Scarpa haematoma evacuated on D+7 and 
a retroperitoneal haematoma evacuated on D+1, leaving the complication of a reversible left femoral 
nerve paresis. Late postoperative complications related to surgery were a 16mmØ false aneurysm in 
the left prosthesis-femoral anastomosis and a graft occlusion detected by Doppler 19 months after the 
procedure. No infectious complications were reported during the study. Some other postoperative 
complications were reported but concluded not to be associated with the prosthesis or the procedure.  
Case reports (published data)  
A total of 7 case reports, describing the use of POLYTHESE® vascular prostheses in a limited number of 
patients (from 1 to 6 patients) have been identified, recording a total of 15 patients.  
These case reports describe the use of POLYTHESE® vascular prostheses in the following procedures: 
• 
Prosthetic graft replacement of the ascending aorta or aortic arch following an aneurysm 
(Touati 2003, Yazici 2012, Baydar 2013, Martens 2013, Alexoiu 2014, Kollias 2014)  
• 
Prosthetic graft replacement of a descending aortic aneurysm (Colak 2012)  
 
Touati et al. (2003) described six cases of patients (median age of 57.6±11 years) who were candidates 
for a new strategy of normothermic perfusion for replacement of the aortic arch to avoid the 
complications of profound hypothermic circulatory arrest. A POLYTHESE® vascular prosthesis was used 
in all patients. No patient died and all woke without neurologic deficit. No transient or permanent 
neurologic deficit was observed.  
Colak et al. (2012) presented a case of 56-year-old woman with a history of prosthetic graft 
replacement of the ascending aortic and total aortic arch, using the elephant trunk technique 12 years 
previously for acute aortic dissection. Patient was admitted for surgical treatment of a descending 

 
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aortic aneurysm (6.8 cm in diameter) with the previously placed prosthetic graft detected in the 
aneurysm. Complete occlusion of the elephant trunk portion of the graft was achieved by inflating a 
compliant aortic occlusion balloon. A new graft, 28-mm diameter POLYTHESE® was placed with a 
polypropylene running suture to the elephant trunk. The prosthesis was then wrapped with the 
aneurysmal wall. The postoperative course was uneventful. She was discharged home on the fourth 
postoperative day in good condition. 
Yazici et al. (2012) presented a case of 66-year-old male who had an intimal flap in the ascending aorta 
with a diagnosis of type A aortic dissection. A hemiarch replacement was therefore performed with a 
30 mm diameter POLYTHESE®. Early postoperative course was uneventful, but, an acute renal failure 
was developed in day 3 and treated medically. No other complications occurred. Patient was 
discharged in Day 16, and was well during the 15-months follow up.  
Baydar et al. (2013) reported a case of a 41-year-old woman who had a left ventricular outflow tract 
pseudoaneurysm following aortic valve replacement, which was reconstructed with a 24 mm diameter 
POLYTHESE®. The patient’s postoperative course was uneventful, and a control transthoracic 
echocardiography evaluation showed a good surgical repair. She was discharged on the sixth 
postoperative day. Currently, the patient is under follow-up without any problem (no further detail).  
Martens et al. (2013) described a case report of a 32-year-old male who was initially diagnosed with a 
saccular aneurysm (maximal diameter of 69 mm) of the right common iliac artery and a partially 
thrombosed left common iliac artery aneurysm. Patient was treated with an aortobifurcated graft in 
an end-to-end confirguration to both internal and external iliac arteries, without complications. A 
diagnostic workup revealed a dilated aortic root of 49 mm at the level of the sinuses of Valsalva. A 
second procedure was conducted to replace the dilated aortic root with reimplantation of the aortic 
valve and the coronary buttons in a 28 mm diameter POLYTHESE®. The postoperative recovery was 
uneventful and the patient was discharged on postoperative day 7 with good outcome.  
Alexoiu et al. (2014) reported a case of a 73 year-old male who had communication between aortic 
aneurysm and the origin of the left pulmonary artery (aorto-pulmonary fistula). Total aortic arch 
replacement was conducted with short elephant-trunk extension into the ascending aorta using a 24 
mm diameter POLYTHESE®. The left subclavian artery was reimplanted into the ascending aorta using 
a Gelweave graft and the expected 8-mm fistula was obliterated through the inside aneurysmal sac 
using small Gore-tex patch. Postoperative CT scan control at 3 months confirmed satisfactory exclusion 
of the aortic aneurysm, closure of the fistula and decompression of the left pulmonary artery. This case 
report did not describe complication. 
Kollias et al. (2014) presented cases report of 4 patients with atherosclerotic aortic arch and 
descending thoracic aorta (DTA) aneurysms where a hybrid repair surgery technique was performed. 
All patients were assessed to be at high risk for conventional open repair. This technique employs 
surgical debranching and revascularization of the aortic arch, and placement of endovascular stent-
grafts within the ascending aorta, the aortic arch and the DTA. Surgical procedure used the proximal 
end of a bifurcated POLYTHESE® vascular graft which was stitched by an end-to-side technique the rest 
of the vasculature except the last anastomosis with the left carotid artery done by an end-to-end 
anastomosis. There were no strokes or spinal cord ischemic injuries, even in the cases with extensive 
DTA stent-grafting.  

 
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5.2. Rationale for PMCF study 
Available evidence confirms acceptability of performance and side effects related to POLYTHESE®; 
however, intended claims on clinical safety and performance are not sufficiently supported with 
existing clinical evidence, especially for long term assessment and thoracic use. In order to keep 
POLYTHESE® in European market, a post-market clinical follow-up (PMCF) study is needed. 
5.3. Subjects 
The participating hospitals will screen all potential subjects and will select those who are appropriate 
for study inclusion, i.e. subjects implanted with POLYTHESE® for at least one year, or with complete 
data to death. As the study explores real world data, there is no exclusion criteria for subjects and all 
subjects with POLYTHESE® implanted for at least one year and have not objected to the collect of their 
data will be included in the study. 
All data will be retrieved from medical charts for each patient from time of surgery (considered as 
index date) until a maximum of 5 years after surgery. 
Data from a minimum of 300 from 3 to 8 different sites in France will be evaluated. A minimum of 200 
subjects with thoracic location of surgery will be evaluated. 
Not more than 50% of study total enrolled subjects shall pertain to one unique centre.  
5.3.1. Inclusion criteria  
Patients must meet the following inclusion criteria in order to be eligible for inclusion in the study:  
• 
Patient has a minimum of 1-year post-operative follow-up data available, or complete data to 
death 
5.3.2. Exclusion criteria  
There are no exclusion criteria apart from patients who have objected to the collect of their data.  
6. RISKS AND BENEFITS OF THE DEVICE  
6.1. Anticipated clinical benefits 
There is no clinical benefit expected from the study as the evaluated device is already commercially 
available and used in routine, and as there will be no extra procedure for subjects who have been 
already implanted and followed. The study will only analyse already collected data. 
There is no anticipated additional clinical benefit expected from the use of POLYTHESE® devices rather 
than other commercially available similar devices with same indications for use. 
Anticipated clinical benefits of the device are thus equivalent to anticipated clinical benefits of open 
surgical vascular repair of thoracic, abdominal and peripheral arteries.  

 
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Replacement or bypass of arteries presenting obliterative arterial disease is required to restore the 
function of the artery: restore the blood flow to distal tissues. Anticipated clinical benefits may consist 
in patient’s symptoms relief, improved quality of life and reduced tissular ischemia, amputation and 
mortality risks. 
Replacement or bypass of arteries presenting dissection and/or aneurysmal disease is required to 
exclude the false lumen entry tear(s) and/or aneurysmal part without compromising the blood flow to 
distal tissues. Anticipated clinical benefits may consist in reduced risks of dissection and/or aneurysm 
associated complications and reduced risk of aneurysm rupture and mortality. 
6.2. Anticipated risks 
There is no risk either associated to the study as there is no procedure performed in the scope of the 
study. The risks listed below are those related to revascularization surgery and use of grafts and will 
be the ones monitored 
The type and rate of anticipated risks may differ according to indication and location of the surgical 
procedure, and may result in: 
- 
Medically important event or reaction  
- 
Persistent or significant incapacity or substantial disruption of the ability to conduct normal 
life functions 
- 
Re-intervention and re-hospitalization or prolongation of existing hospitalization  
- 
Life-threatening event, reaction up to death.  
Early (peri-operative) and late adverse events of abdominal aortic and peripheral arteries open 
vascular repair with POLYTHESE® devices include (but are not restricted to): 
- 
Bleeding 
- 
Hematoma  
- 
Adherence to surrounding tissues  
- 
Allergic reaction  
- 
Inflammatory reaction / oedema  
- 
Seroma / lymphorrea formation  
- 
Wound complications: infection (superficial or deep), revision  
- 
Graft infection 
- 
Graft dilatation  
- 
Pseudo aneurysm / false aneurysm (para-anastomotic aneurysm; non-anastomotic aneurysm) 
- 
Graft stenosis / occlusion  
- 
Limb occlusion 
- 
Amputation (major or minor) 
- 
Secondary aorto-enteric fistula 
- 
Renal dysfunction 
- 
Neurologic deficit  
- 
Pericardial effusion  

 
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- 
Pulmonary complication (pneumonia, perioperative acute pulmonary oedema) 
- 
Cardiac complications (myocardial infarction or arrhythmia, ischemic heart disease, atrial 
fibrillation)  
7. OBJECTIVES AND ENDPOINTS 
The principal objective of the POLYTHESE® study is to describe safety and performance of POLYTHESE®. 
Identification and analysis of potential emergent risks will be performed according to the availability 
of the collected adverse events. 
Identification of possible systematic misuse or off-label use of POLYTHESE®, with a view to verifying 
that the intended purpose is correct, will also be performed according to the availability of the data.  
The following table summarizes the performance and safety endpoints and timeframe after surgery.  
 
 
Time period following surgery 
Study endpoints 
At surgery 
30 days 
6 months 
1 year 
>1 year until 5 years 
of follow-up 
 
Performance endpoints 
Primary patency rate* 
--- 
X 
X 
X* 
X 
Primary assisted patency rate 
--- 
X 
X 
X 
X 
Secondary patency rate 
--- 
X 
X 
X 
X 
Device Failure 
X 
X 
X 
X 
X 
Procedural success rate 
X 
--- 
--- 
--- 
--- 
 
Safety endpoints 
Mortality rate*  
X 
X* 
X 
X 
X 
Limb salvage rate  
--- 
X 
X 
X 
X 
Adverse events ** 
X 
X 
X 
X 
X 
* Primary endpoint 
** Listed in section 6.2 
7.1. Performance endpoints 
Primary performance endpoints are primary patency rate at 1 year after surgery using POLYTHESE®. 
The others effectiveness endpoints are: 
- 
Procedural success rate, defined as: 
o 
Ability to use with no need for replacement by another device and,  
o 
Effective vascular flow restoration after procedure and,  
o 
In case of aneurysm, exclusion of aneurysmal portion after procedure. 

 
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- 
Primary patency rate, defined as rate patency of the bypass graft without procedure or 
intervention of the conduit itself (except for occlusion)  
- 
Primary assisted patency rate, defined as rate patency of the bypass graft with or without 
procedure or intervention of the conduit itself (except for occlusion) after device implantation  
- 
Secondary patency, defined as rate patency of the bypass graft with or without procedure or 
intervention of the conduit itself for occlusion after device implantation  
- 
Device Failure, defined as:  
o Uncontrolled blood leakage from device  
o Loss of structural integrity, e.g. rupture and/or exaggerated dilation (> 50 %)  
o Occlusion of the device  
o Total or partial replacement of the device required 
 
7.2. Safety endpoints  
Primary safety endpoint is mortality rates at 30 days after surgery using POLYTHESE®. 
- 
Others study safety endpoints are: 
o Mortality rate, defined as freedom % from death  
o Limb salvage rate, defined as freedom % from target limb amputation  
o Adverse events, defined as any documented adverse events, including anticipated (as 
listed in section 6.2) and non-anticipated adverse events.   
8. STATISTICAL CONSIDERATIONS  
8.1. Statistical design, method and analytical procedures 
All patients participating in the study who met the eligibility criteria will be included in the study 
population.  
A descriptive analysis with clinical characteristics of all patients included in the study will be performed 
at the index date.  
Exploratory analyses will be conducted globally and stratified by sub-populations. Sub-populations will 
be defined according to the three main areas of surgery: 
• 
Thoracic 
o Ascending aorta and/or aortic arch and/or descending thoracic aorta and/or thoraco-
abdominal aorta  
• 
Abdominal 
o Aorto-aortic and/or aorto-iliac and/or aorto-femoral repair 
• 
Peripheral 

 
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o Peripheral artery repair and extra anatomic bypasses not crossing the knee flexion 
crease 
Since no hypotheses will be tested, study objectives will be addressed using descriptive statistics only. 
Given the real-world nature of the data, the use of multiple imputation methods for missing data would 
introduce bias as missing data cannot be considered completely at random (MCAR) or at random 
(MAR). Variables will not be imputed, with the exception of dates in which the exact day is missing: 
the missing day will be replaced by the middle day of the month.  
Continuous variables will be described with number of patients with valid / missing observations, mean 
and its 95% confidence interval (95%CI), standard deviation (SD), median, 25 and 75 percentiles (P25 
and P75, respectively), minimum and maximum. For non-normally distributed continuous variables 
geometric mean and its 95%CI will be reported too.  
For categorical variables counts and percentages per category will be presented. Missing observations 
(including invalid or outlier observations) will be tabulated as a separate category. The calculation of 
proportions will not include the missing/invalid category in the denominators. 
P-values will be presented in the summary tables, in association with the descriptive statistics. In 
addition, 95% confidence intervals (95%CI) will be presented when considered convenient or relevant. 
Results will be graphically represented when appropriate to make interpretation easier. 
The two-sided level of significance will be set at 0.05 for all the statistical tests performed.  
Statistical calculations will be carried out by using R software. More details on the statistical analysis 
will be provided in the Statistical Analysis Plan. 
8.1. Sample size justification 
Data from a minimum of 300 subjects will be evaluated. A minimum of 200 subjects will be evaluated 
for thoracic location of surgery. The number of patients has been chosen in accordance with the 
realistic number of operated patients in the involved hospitals. 
 
9. DATA MANAGEMENT 
9.1. Data sources 
Real World Data sources used to generate Real World Evidence are:  
- 
Data derived from Electronic health Record  
- 
Medical claims and/or billing data 
- 
Product and/or disease registry data 

 
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9.2. Data to collect 
As mentioned previously considering study is retrospective and considering that every site can have 
different ways to follow their patients after surgery, data will be collected as much as possible in order 
to determine the clinical safety and performance. 
The following data will be collected, when available according to participating site available data.  
• 
Identification and demographic data  
o Patient identification  
o Indication and location of the treatment 
o Location of the surgery  
o Patients demographics 
§ 
Year of birth 
§ 
Sex  
§ 
Mass  
o Identification of implanting physician  
o Name of the institution  
• 
Pre-operative data 
o Risks factors, such as hypertension, diabetes, coronary artery disease, 
hyperlipidaemia, tobacco use, obesity, anaesthesia risk and any cardiovascular risk 
factor.  
o Summary of previous vascular interventions at the same or other relevant vascular 
sites, including non-surgical interventions and previously implanted vascular devices 
(e.g. stents, endovascular prostheses, surgically placed vascular grafts) 
o Relevant medications 
o Diagnostic criteria  
§ 
Clinical assessment (e.g. non-invasive hemodynamic assessment); 
§ 
Objective assessment (e.g. C.T. scanning, magnetic resonance imaging, 
ultrasonography, arteriography, duplex Doppler) 
• 
Operative data  
o Date of procedure  
o Identification data for the vascular prosthesis including configuration (e.g. straight 
uniform or bifurcated) and diameter  
o Information regarding the procedure: 
§ 
Identity of native vessel treated 

 
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§ 
Details of anastomoses (e.g. type (end-to-end), location 
§ 
Length of prosthesis implanted (if available)  
§ 
Adjunctive vascular procedures  
o Relevant medication (e.g. heparin, other anticoagulants) 
o Assessment of prosthesis function and mode of assessment if available (e.g. 
intraoperative angiography, intraoperative Doppler)  
o Failure modes and adverse operative events  
• 
Post-operative data  
o Interval of follow-up (e.g. discharge or 7 d to 14 d after surgery, 30 days, 6 and 12 
months after surgery, up to 5 years for exploratory time points) 
o Date of follow-up visits 
o Summary of vascular interventions, including minimally invasive procedures 
o Clinical evaluation: 
§ 
Clinical assessment (e.g. non-invasive hemodynamic assessment) 
§ 
Objective assessment of prosthesis (e.g. C.T. scanning, magnetic resonance 
imaging, ultrasonography, arteriography, duplex Doppler) 
o Relevant medications (e.g. anticoagulants or antiplatelets) 
o Any documented adverse events including the events listed in section 6.2 anticipated 
risks and any events that lead to the patient’s death  
 
• 
Any documented adverse events data 
As far as available the following data will be collected per adverse event:  
o Type of event, date of occurrence, severity, management (e.g. none, medical 
treatment, endovascular procedure, open surgery), outcome (e.g. continuing, 
resolved, unknown, death) 
o Any Documentation of prosthesis involvement  
o Any Documentation of probable causative factors (e.g. caused by the prosthesis, 
patient factors, technical factors)  
o Explant data: 
§ 
Date 
§ 
Whether the subject is living or deceased 
§ 
Reason for explant, if applicable 

 
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§ 
Relevant observations (e.g. device integrity, device positioning, tissue 
incorporation, vascular tissue erosion), if available 
 
A separate document with all available data to collect will be produced in a second time to add further 
details depending on the level of details available. 
9.3. Data consistency 
Data consistency will be verified for each variable. Harmonization of units (conversion), categorical 
variables consistency and ranges of numerical variables will be also verified. This step will be proceeded 
before database freezing and analyses. If inconsistencies are noticed, monitoring and checks will be 
asked from the sites. 
9.4. Missing data 
Some endpoints can be missing for some subjects. Endpoints proportions will be calculated on the 
number of non-missing observations. No imputation method is planned. 
9.5. Database structuration 
After data consistency step, databases will be compiled to one database frozen for analyses. Variables 
might be created for the analyses. 
 
10. ADVERSE EVENTS DEFINITIONS  
An Adverse Event (AE) 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 studied medical device. 
 
11. SAFETY REPORTING PROCEDURES 
Considering the nature of this PMCF study (retrospective study), only Vigilance reporting applies. Any 
event that meets the vigilance criteria as per MEDDEV 2.12-1 and that would not have already been 
reported to the Authorities will be reported in accordance to manufacturer and hospital/manufacturer 
standard procedures.  

 
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12. REGULATORY CONSIDERATIONS 
This PMCF study will be conducted in accordance with the ethical principles that have their origin in 
the Declaration of Helsinki and any regional or national regulations applicable in France.  
This PMCF study will be conducted in compliance with GDPR and by following the Methodology of 
Reference MR-004 developed by CNIL (French Data Protection Agency).  
The principals set forth in the ISO14155:2011 will be followed as far as possible considering the nature 
of this PMCF study (retrospective collect of data).  
13. INFORMED CONSENT PROCESS 
An information letter explaining the purpose of this PMCF study will be sent to patients who meet the 
inclusion criteria. In accordance with the MR-004, the collection of data of patients who have not 
objected this collect will be initiated.   
The completion of this process will be recorded in study documentation.  
14. MONITORING OF THE STUDY  
The conduct of this retrospective study will be monitored by the sponsor to ensure that it is conducted, 
recorded and reported in accordance with this protocol and the applicable regulatory requirements.  
A centralized visit (phone call) will be performed at the start of the study, during the study to oversee 
its progress and at the end of the study.  
15. CONFIDENTIALITY OF THE STUDY   
Subjects will be identified by a study number and subject identification code. Subject ID log will be 
maintained in a secure storage facility and archived for at least 2 years after study completion or for a 
longer period as required by the local regulations. Study records will not be destroyed without 
authorisation from the Sponsor.  
16. PUBLICATION POLICY 
16.1. 
Multicentre Publication 
The sponsor may invite the participating hospitals to take part to a multicenter publication of the study 
results, in which case it will be ensured that the documents submitted for publication comply with the 
publisher’s requirements for authors and contributors. Also, the sponsor will select a publisher based 
on mutual agreement with the participating hospitals, who are invited to participate in the publication. 

 
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16.2. 
Publication 
The participating hospitals may publish his/her own data subject to the following restrictions: 
- 
the multicenter manuscript must be published prior to each participating hospital publishing their 
own data; 
- 
the manuscript shall be submitted to the Sponsor for review prior to submitting the manuscript 
for publication; 
- 
the manuscript must reference the study multicenter manuscript. 
17. CLINICAL STUDY REPORT 
The Sponsor will prepare a Clinical Study Report that will comprehensively describe study findings. 
Before finalization, a draft will be circulated to the participating hospital physician for review and 
endorsement. 
 
 
18. BIBLIOGRAPHY 
1. Tofigh, A. Mohammadi; Warnier De Wailly, G.; Rhissassi, B. (2007) Comparing vein with 
collagen impregnated woven polyester prosthesis in above-knee femoropopliteal bypass 
grafting. In : International journal of surgery (London, England), vol. 5, n° 2, p. 109–113. DOI: 
10.1016/j.ijsu.2006.07.003.  
2. Alexoiu, Valerica Lenuta; Ou, Phalla; Messika-Zeitoun, David; Jacob, Brice Lortat; Kirsch, 
Matthias (2014) Post-Traumatic Aortic Arch Aneurysm Complicated by Aorto-Pulmonary 
Fistula. In : Aorta (Stamford, Conn.), vol. 2, n° 6, p. 293–295. DOI: 10.12945/j.aorta.2014.14-
035.  
3. Baydar, Onur; Coşkun, Ugur; Balaban, Betul; Cetin, Gurkan; Firatli, Inci; Ersanli, Murat Kazim; 
Kucukoglu, Mehmet Serdar (2013) Cardiac tamponade due to left ventricular pseudoaneurysm 
after aortic valve replacement. In : The heart surgery forum, vol. 16, n° 1, E49-51. DOI: 
10.1532/HSF98.20121083.  
4. Benetis, Rimantas; Kavaliauskiene, Zana; Antusevas, Aleksandras; Kaupas, Rytis Stasys; Inciura, 
Donatas; Kinduris, Sarunas (2016) Comparison of results of endovascular stenting and bypass 
grafting for TransAtlantic Inter-Society (TASC II) type B, C and D iliac occlusive disease. In : 
Archives of medical science : AMS, vol. 12, n° 2, p. 353–359. DOI: 10.5114/aoms.2016.59261.  
5. Colak, Necmettin; Nazli, Yunus; Kirbas, Ismail; Cakir, Omer (2012) Transbrachial endoclamping 
of the graft for descending aortic aneurysm after the elephant trunk procedure. In : The Annals 
of thoracic surgery, vol. 93, n° 3, p. 1004–1006. DOI: 10.1016/j.athoracsur.2011.10.071.  

 
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6. Kaplan, Mehmet; Temur, Bahar; Can, Tolga; Abay, Gunseli; Olsun, Adlan; Aydogan, Hakki 
(2015) Open distal anastomosis technique for ascending aortic aneurysm repair without 
cerebral perfusion. In : The heart surgery forum, vol. 18, n° 4, E124-8. DOI: 10.1532/hsf.1284.  
7. Kollias VD (2014) Single-stage, off-pump hybrid repair of extensive aneurysms of the aortic 
arch and the descending thoracic aorta. In : Hellenic J Cardiol., 55(5):355-60.  
8. Martens, Thomas; van Herzeele, Isabelle; Ryck, Frederic de; Renard, Marjolijn; Paepe, Anne 
de; François, Katrien et al. (2013) Multiple aneurysms in a patient with aneurysms-
osteoarthritis syndrome. In : The Annals of thoracic surgery, vol. 95, n° 1, p. 332–335. DOI: 
10.1016/j.athoracsur.2012.05.085.  
9. Touati, Gilles D.; Roux, Nicolas; Carmi, Doron; Degandt, Alexandra; Benamar, Amar; Marticho, 
Paul et al. (2003) Totally normothermic aortic arch replacement without circulatory arrest. In 
: The Annals of thoracic surgery, vol. 76, n° 6, p. 2115–2117. DOI: 10.1016/S0003-
4975(03)00739-2.  
10. Yazici, Pinar; Oz, Kursad; Celik, Omer; Erek, Ersin (2012) Extensive anterior chest wall 
ecchymosis as a sign of subacute type A aortic dissection. In : Interactive cardiovascular and 
thoracic surgery, vol. 15, n° 4, p. 797–799. DOI: 10.1093/icvts/ivs204.  
 
 

 
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19. APPENDIX 
Table 1: POLYTHESE® IC CE-marked straight tube reference 
 
Reference 
Diameter (mm) 
Length (cm) 
MD Class 
1201 0600 
6 
60 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
III 
1201 0601 
6 
100 
1201 0602 
6 
15 
1201 0603 
6 
70 
1201 0700 
7 
60 
1201 0701 
7 
100 
1201 0702 
7 
15 
1201 0703 
7 
70 
1201 0800 
8 
60 
1201 0801 
8 
100 
1201 0802 
8 
15 
1201 0803 
8 
70 
1201 1000 
10 
60 
1201 1001 
10 
100 
1201 1002 
10 
15 
1201 1003 
10 
70 
1201 1200 
12 
60 
1201 1202 
12 
15 
1201 1203 
12 
70 
1201 1400 
14 
40 
1201 1401 
14 
60 
1201 1402 
14 
15 
1201 1600 
16 
40 
1201 1601 
16 
60 
1201 1602 
16 
15 
1201 1800 
18 
40 
1201 1801 
18 
60 
1201 1802 
18 
15 
1201 2000 
20 
40 
1201 2001 
20 
60 
1201 2002 
20 
15 
1201 2200 
22 
40 
1201 2201 
22 
60 
1201 2202 
22 
15 
1201 2400 
24 
40 
1201 2401 
24 
60 
1201 2402 
24 
15 
1201 2600 
26 
40 
1201 2601 
26 
60 
1201 2602 
26 
15 
1201 2608 
26 
8 
1201 2800 
28 
40 
1201 2801 
28 
60 
1201 2802 
28 
15 
1201 2808 
28 
8 
 
 
Table 2: POLYTHESE® IC CE-marked bifurcated references 
 
Reference 
Diameter (mm) 
Length (cm) 
MD Class 
1202 1206 
12 x 6 
45 
 
 
 
III 
1202 1407 
14 x 7 
45 
1202 1608 
16 x 8 
45 
1202 1809 
18 x 9 
45 
1202 2010 
20 x 10 
45 

 
PROTOCOL 
TITLE: 
2021-PT-01  
Safety and Performance of POLYTHESE® vascular prosthesis 
EFFECTIVE DATE: 
1 July 2021 
 
 
 
 
Version: 1 
CONFIDENTIAL, PRINTED COPIES FOR REFERENCE ONLY 
Page 29/29 
 
1202 2211 
22 x 11 
45 
1202 2412 
24 x 12 
45 
 
 
Table 3: POLYTHESE® ICT CE-marked straight bifurcated references 
 
Reference 
Diameter (mm) 
Length (cm) 
MD Class 
1301 3000 
30 
30 
 
 
 
 
 
 
 
III 
1301 3001 
30 
60 
1301 3002 
30 
15 
1301 3008 
30 
8 
1301 3200 
32 
30 
1301 3201 
32 
60 
1301 3202 
32 
15 
1301 3400 
34 
30 
1301 3401 
34 
60 
1301 3402 
34 
15 
1301 3600 
36 
30 
1301 3601 
36 
60 
1301 3602 
36 
15 
1301 3800 
38 
30 
1301 3801 
38 
60 
1301 3802 
38 
15 
 
Table 4: POLYTHESE® IC-3GL CE-marked references 
 
Reference 
Diameter (mm) 
Length (cm) 
MD Class 
PT3GL020015 
20 
15  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
III 
PT3GL020030 
20 
30  
PT3GL020060 
20 
60  
PT3GL022015 
22 
15  
PT3GL022030 
22 
30  
PT3GL022060 
22 
60  
PT3GL024015 
24 
15  
PT3GL024030 
24 
30  
PT3GL024060 
24 
60 
PT3GL026015 
26 
15  
PT3GL026030 
26 
30  
PT3GL026060 
26 
60  
PT3GL028015 
28 
15  
PT3GL028030 
28 
30  
PT3GL028060 
28 
60  
PT3GL030015 
30 
15  
PT3GL030030 
30 
30  
PT3GL030060 
30 
60  
PT3GL032015 
32 
15  
PT3GL032030 
32 
30  
PT3GL032060 
32 
60  
PT3GL034015 
34 
15  
PT3GL034030 
34 
30  
PT3GL034060 
34 
60  
PT3GL036015 
36 
15  
PT3GL036030 
36 
30  
PT3GL036060 
36 
60  
PT3GL038015 
38 
15  
PT3GL038030 
38 
30  
PT3GL038060 
38 
60