A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data on POLYMAILLE®C
Conditions: Abdominal Vascular Surgery, Peripheral Vascular Surgery, Vascular Prothesis, Aneurysm Abdominal, Aneurysm; Peripheral, Obliterative Arterail Disease
Sponsor: Perouse Medical

 
PROTOCOL 
TITLE: 
2020-PMC-01  
Safety and Performance of POLYMAILLE® C vascular prosthesis 
EFFECTIVE DATE: 
15 January 2021 
 
 
 
 
Version: 1 
CONFIDENTIAL, PRINTED COPIES FOR REFERENCE ONLY 
Page 1/27 
 
A Retrospective, Observational, Multicenter, Study 
to Collect Clinical Safety and Performance data on 
POLYMAILLE®C  
 - Protocol 2020-PMC-01 
Version 1 
 
Author 
Date & Signature 
Location 
Armêl PLAINE 
Clinical Trial Operations 
 
ECLEVAR MEDTECH 
8 rue Vernier 
75017 PARIS 
Jihane TAMINE 
Head of RW solutions 
 
ECLEVAR MEDTECH 
8 rue Vernier 
75017 PARIS 
Verifiers 
Date & Signature 
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 
Approver 
Date & Signature 
Location 
Agnès JORDAN 
Regulatory Affairs DIRECTOR 
 
PEROUSE MEDICAL 
Route du Manoir 
60173 IVRY-LE-TEMPLE 
 
Study Product Name:  
POLYMAILLE® C vascular prosthesis 
Sponsor/manufacturer:        
PEROUSE Medical 
 
 
 
 
Route du Manoir, 
60173 Ivry-le-Temple 
France 
Participating sites: 
 
To be detailed in separate document 
 
 
 
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PROTOCOL 
TITLE: 
2020-PMC-01  
Safety and Performance of POLYMAILLE® C vascular prosthesis 
EFFECTIVE DATE: 
15 January 2021 
 
 
 
 
Version: 1 
CONFIDENTIAL, PRINTED COPIES FOR REFERENCE ONLY 
Page 2/27 
 
CONTENTS 
Contents .................................................................................................................................................. 2 
1. 
List of Abbreviations ........................................................................................................................ 4 
2. 
Synopsis ........................................................................................................................................... 5 
3. 
Introduction. .................................................................................................................................... 8 
4. 
Study device .................................................................................................................................... 8 
4.1. 
Summary description of the device ......................................................................................... 8 
4.2. 
Intended purpose and patient population ............................................................................ 11 
4.2.1. 
Intended clinical purpose .............................................................................................. 11 
4.2.2. 
Patient population characteristics................................................................................. 11 
4.3. 
Contra-indications ................................................................................................................. 12 
5. 
Study design .................................................................................................................................. 13 
5.1. 
Summary of relevant Clinical data ........................................................................................ 13 
5.2. 
Rationale for PMCF study ...................................................................................................... 15 
5.3. 
Subjects ................................................................................................................................. 15 
5.3.1. 
Inclusion criteria ............................................................................................................ 15 
5.3.2. 
Exclusion criteria ........................................................................................................... 15 
6. 
Risks and benefits of the device .................................................................................................... 16 
6.1. 
Anticipated clinical benefits .................................................................................................. 16 
6.2. 
Anticipated risks .................................................................................................................... 16 
7. 
Objectives and Endpoints .............................................................................................................. 17 
7.1. 
Performance endpoints ......................................................................................................... 19 
7.2. 
Safety endpoints .................................................................................................................... 19 
8. 
Statistical considerations ............................................................................................................... 20 
8.1. 
Statistical design, method and analytical procedures ........................................................... 20 
8.2. 
Sample size justification ........................................................................................................ 20 
9. 
Data management ......................................................................................................................... 22 
9.1. 
Data sources .......................................................................................................................... 22 
9.2. 
Data to collect ....................................................................................................................... 22 
9.3. 
Data consistency .................................................................................................................... 24 
9.4. 
Missing data .......................................................................................................................... 24 
9.5. 
Database structuration .......................................................................................................... 24 
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PROTOCOL 
TITLE: 
2020-PMC-01  
Safety and Performance of POLYMAILLE® C vascular prosthesis 
EFFECTIVE DATE: 
15 January 2021 
 
 
 
 
Version: 1 
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10. 
Adverse events DEFINITIONS .................................................................................................... 24 
11. 
SAFETY REPORTING PROCEDURES ............................................................................................ 25 
12. 
REGULATORY CONSIDERATIONS ............................................................................................... 25 
13. 
Informed Consent Process ........................................................................................................ 25 
14. 
monitorING of the study ........................................................................................................... 25 
15. 
Confidentiality of the study ....................................................................................................... 25 
16. 
Publication policy ...................................................................................................................... 26 
16.1. 
Multicentre Publication ..................................................................................................... 26 
16.2. 
Publication ......................................................................................................................... 26 
17. 
Clinical Study Report ................................................................................................................. 26 
18. 
Bibliography ............................................................................................................................... 27 
 
 
 
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PROTOCOL 
TITLE: 
2020-PMC-01  
Safety and Performance of POLYMAILLE® C vascular prosthesis 
EFFECTIVE DATE: 
15 January 2021 
 
 
 
 
Version: 1 
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1. LIST OF ABBREVIATIONS 
AAA 
 
Abdominal aortic aneurysm 
ADE 
 
Adverse Device Effect  
AE 
 
Adverse Event  
CER 
 
Clinical Evaluation Report 
CTO  
 
Chronic Total Occlusion  
IAA 
 
Iliac Artery Aneurysm  
IC 
 
Intermittent Claudication  
ISO  
 
International Organization for Standardization 
MEDDEV  
MEDical DEVice (i.e. European Commission’s official guidance for medical devices) 
PMCF   
Post-Market Clinical Follow-up  
CLTI 
 
Chronic Limb Threatening Ischemia  
 
 
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PROTOCOL 
TITLE: 
2020-PMC-01  
Safety and Performance of POLYMAILLE® C vascular prosthesis 
EFFECTIVE DATE: 
15 January 2021 
 
 
 
 
Version: 1 
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Page 5/27 
 
2. SYNOPSIS 
Title: 
A Retrospective, Observational, Multicentre Study to Collect 
Clinical Safety and Performance data on POLYMAILLE® C 
vascular prosthesis 
Study Population: 
Subjects who did receive POLYMAILLE® C at least one year ago for 
replacement or bypass of arteries. 2 main sub-populations will be 
studied depending on location of surgery (abdominal and 
peripheral), but data will be collected for all subjects who did 
receive POLYMAILLE® C. 
Study Design: 
Multi-center retrospective case series  
Study Type: 
PMCF 
Number of subjects: 
Data from a minimum of 200 subjects will be evaluated. A 
minimum of 100 subjects will be evaluated for each main location 
of surgery (abdominal and peripheral). 
Follow-up 
At least 1 year follow-up after surgery until a maximum of 5 years. 
Study Product: 
POLYMAILLE® C vascular prosthesis 
Intended use: 
POLYMAILLE®C vascular prostheses are indicated for replacement 
or bypass of arteries presenting aneurysm or obliterative arterial 
disease. Their indication is restricted to abdominal and peripheral 
surgery not crossing the knee flexion crease. 
Objectives: 
Describe safety and performance of POLYMAILLE® C  
Performance primary 
endpoint:  
Primary patency rate at 1 year after surgery using POLYMAILLE® 
C  
Safety primary endpoint: 
Mortality 
rate 
at 
30 
days 
after 
surgery 
using  
POLYMAILLE® C  
Performance secondary 
endpoints: 
 
Procedural success rate 
 
Primary patency rate at 30 days and 6 months after 
surgery using POLYMAILLE® C  
 
Primary assisted patency rate at 30 days, 6 months and 1 
year after surgery using POLYMAILLE® C  
 
Secondary patency rate at 30 days, 6 months and 1 year 
after surgery using POLYMAILLE® C  
 
Device failure during procedure or at discharge, at 30 
days, 6 months and 1 year after surgery using 
POLYMAILLE® C 
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PROTOCOL 
TITLE: 
2020-PMC-01  
Safety and Performance of POLYMAILLE® C vascular prosthesis 
EFFECTIVE DATE: 
15 January 2021 
 
 
 
 
Version: 1 
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Safety secondary endpoints 
 
Mortality rate during procedure or at discharge, at 6 
months and 1 year after surgery using POLYMAILLE® C  
 
Limb salvage rate at 30 days, 6 months and 1 year after 
surgery using POLYMAILLE® C  
 
Adverse event during procedure or at discharge, at 30 
days, 6 months and 1 year after surgery using 
POLYMAILLE® C 
Exploratory endpoints  
- 
After 1 year until the end of follow-up (5 years) using 
POLYMAILLE® C:  
o Primary patency  
o Primary assisted patency  
o Secondary patency  
o Device failure  
o Mortality  
o Limb salvage 
o Adverse events  
- 
Identify possible systematic misuse or off-label use of 
POLYMAILLE® C, with a view to verifying that the 
intended clinical purpose is correct. 
Inclusion criteria 
Subjects who did receive POLYMAILLE® C at least one year ago for 
replacement or bypass of pathological arteries. 
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 
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PROTOCOL 
TITLE: 
2020-PMC-01  
Safety and Performance of POLYMAILLE® C vascular prosthesis 
EFFECTIVE DATE: 
15 January 2021 
 
 
 
 
Version: 1 
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Data to be collected (as far as 
available) 
 
 
Identification and demographic data  
o Patient identification  
o Indication and location of the lesion(s)   
o Patients demographics and risk factors  
o Summary 
of 
previous 
cardiovascular 
interventions  
o Relevant medications 
o Diagnosis  
 
Operative data  
o Date of procedure  
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)  
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PROTOCOL 
TITLE: 
2020-PMC-01  
Safety and Performance of POLYMAILLE® C vascular prosthesis 
EFFECTIVE DATE: 
15 January 2021 
 
 
 
 
Version: 1 
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Timepoints of interests 
- 
During procedure and at discharge (7-14 days) 
- 
30-days after surgery (‘peri-operative’) 
- 
6, 12 months 
- 
 After 1 year until the end of follow-up (5 years) 
 
3. INTRODUCTION.  
POLYMAILLE® C devices are CE-marked and were initially introduced in the international market in 
2002. Since January 2004, more than 55 000 single devices have been sold across various markets 
worldwide. 
 
4. STUDY DEVICE 
4.1. Summary description of the device  
The studied device is POLYMAILLE® C (Figure 1), which consists in uniform straight or bifurcated tubular 
synthetic textile coated vascular grafts.  
POLYMAILLE® C vascular grafts are made by knitting of polyethylene terephthalate (PET – polyester) 
yarns and impregnated with collagen CXE® coating of bovine origin.   
CXE® collagen impregnation of the POLYMAILLE® C vascular grafts ensure water permeability of less 
than 5 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. 
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PROTOCOL 
TITLE: 
2020-PMC-01  
Safety and Performance of POLYMAILLE® C vascular prosthesis 
EFFECTIVE DATE: 
15 January 2021 
 
 
 
 
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Figure 1: Uniform straight and bifurcated POLYMAILLE® C vascular grafts 
POLYMAILLE® C vascular grafts are available in different configurations as summarized in the below 
tables:  
Table 1 – POLYMAILLE® C CE-marked straight references  
Reference  
Nominal relaxed and 
pressurized inner 
diameter (mm)  
Minimum usable 
length (cm)  
PMC000640  
6  
40  
PMC000660  
6  
60  
PMC000670  
6  
70  
PMC0006100  
6  
100  
PMC000740  
7  
40  
PMC000760  
7  
60  
PMC000770  
7  
70  
PMC0007100  
7  
100  
PMC000840  
8  
40  
PMC000860  
8  
60  
PMC000870  
8  
70  
PMC0008100  
8  
100  
PMC001040  
10  
40  
PMC001060  
10  
60  
PMC001070  
10  
70  
PMC0010100  
10  
100  
PMC001230  
12  
30  
PMC001240  
12  
40  
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PROTOCOL 
TITLE: 
2020-PMC-01  
Safety and Performance of POLYMAILLE® C vascular prosthesis 
EFFECTIVE DATE: 
15 January 2021 
 
 
 
 
Version: 1 
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Reference  
Nominal relaxed and 
pressurized inner 
diameter (mm)  
Minimum usable 
length (cm)  
PMC001260  
12  
60  
PMC001270  
12  
70  
PMC001415  
14  
15  
PMC001430  
14  
30  
PMC001440  
14  
40  
PMC001460  
14  
60  
PMC001470  
14  
70  
PMC001615  
16  
15  
PMC001630  
16  
30  
PMC001640  
16  
40  
PMC001815  
18  
15  
PMC001830  
18  
30  
PMC001840  
18  
40  
PMC002015  
20  
15  
PMC002030  
20  
30  
PMC002040  
20  
40  
PMC002215  
22  
15  
PMC002230  
22  
30  
PMC002240  
22  
40  
PMC002415  
24  
15  
PMC002430  
24  
30  
PMC002440  
24  
40  
  
  
Table 2 – POLYMAILLE® C CE-marked bifurcated references  
Reference  
Main tube nominal 
relaxed and 
pressurized inner 
diameter (mm) 
Branches 
nominal relaxed and 
pressurized inner 
diameter (mm) 
Minimum 
usable overall 
length (cm)  
PMC120650  
12   
6  
50  
PMC140750  
14   
7  
PMC160850  
16   
8  
PMC180950  
18   
9  
PMC201050  
20   
10  
PMC221150  
22  
11  
PMC241250  
24   
12  
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PROTOCOL 
TITLE: 
2020-PMC-01  
Safety and Performance of POLYMAILLE® C vascular prosthesis 
EFFECTIVE DATE: 
15 January 2021 
 
 
 
 
Version: 1 
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4.2. Intended purpose and patient population 
4.2.1. Intended clinical purpose  
POLYMAILLE®C vascular prostheses are indicated for replacement or bypass of arteries presenting 
aneurysm or obliterative arterial disease. Their indication is restricted to abdominal and peripheral 
surgery not crossing the knee flexion crease. 
Abdominal vascular surgery includes abdominal aorto-aortic and/or aorto-iliac and/or aorto-femoral 
vascular repair, i.e. graft implantation with proximal anastomosis to abdominal aorta (supra and/or 
infra-renal).  
Peripheral vascular surgery includes peripheral arteries repair, i.e. graft implantation with no aortic 
anastomosis, and/or extra-anatomic vascular repair such as axillo-femoral and/or crossover bypass 
(femoro-femoral and/or ilio-femoral). 
4.2.2. Patient population characteristics  
Patient population conditions that may indicate abdominal 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:  
- 
Abdominal aortic aneurysms (AAA)  
- 
Peripheral arterial aneurysms  
 
Ilia arterial aneurysms (IAA)  
 
Femoral arterial aneurysms (FAA)  
 
Popliteal arterial aneurysms (PAA) 
4.2.2.1. 
Peripheral arterial diseases (PAD)  
Reported PAD risks factors are:  
 
History of cardiovascular disease  
 
Smoking  
 
Diabetes mellitus  
 
Hypertension  
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PROTOCOL 
TITLE: 
2020-PMC-01  
Safety and Performance of POLYMAILLE® C vascular prosthesis 
EFFECTIVE DATE: 
15 January 2021 
 
 
 
 
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 
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,  
 
co-morbidities such as coronary heart disease, diabetes, atherosclerosis.  
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.  
4.3. Contra-indications 
POLYMAILLE®C vascular prostheses are contraindicated for surgery of the thoracic aorta, coronary 
bypass, arteriovenous access, extracorporeal circulation and crossing the knee flexion crease. 
POLYMAILLE®C vascular prostheses are contraindicated in patients with an immune reaction or 
hypersensitivity, known or suspected, to collagen of bovine origin. 
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PROTOCOL 
TITLE: 
2020-PMC-01  
Safety and Performance of POLYMAILLE® C vascular prosthesis 
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15 January 2021 
 
 
 
 
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5. STUDY DESIGN  
POLYMAILLE® C is a retrospective, observational, multicentre, descriptive study which examine short 
and long-term outcomes of using POLYMAILLE® C. This study will be done on all comers Real World 
Data to collect clinical safety and performance data on the device. 
5.1. Summary of relevant Clinical data  
Prospective randomized clinical trial 
El-Barbary (2014) conducted on its own initiative, a prospective randomized clinical trial with the aim 
to compare expanded polytetrafluoroethylene (ePTFE; 6-mm LifeSpan®) prosthesis and collagen-
impregnated knitted polyester (Dacron; 6-mm POLYMAILLE® C) for above-knee (AK) femoro-popliteal 
bypass grafts in chronic ischemia patients. Between March 2010 and September 2012, 44 AK femoro-
popliteal bypass grafts were randomly allocated to either an ePTFE (n=22) or a Dacron (n=22) vascular 
graft (6 mm in diameter). The median age was 62 (35-76) years for ePTFE group and 62 (39-69) years 
for Dacron group. The primary end point of the study was the primary patency at 6, 12 and 24 months. 
Secondary patency, amputation rate and complications were chosen as secondary endpoints. 
Primary patency at 6, 12 and 24 months was 95%, 91% and 76% for PTFE and 95%, 95% and 86% for 
Dacron, respectively (p = 0.47). Secondary patency at 6, 12 and 24 months was 95%, 95% and 86% for 
PTFE and 95%, 95% and 91% for Dacron, respectively (p = 0.77). 
Regarding safety, no deaths occurred within 30 days of surgery. Thirty-days complications occurred 
equally frequent in both groups. The following complications were reported in the Dacron group: 2 
deaths (at 2 years), 1 deep wound infection, 1 major limb amputation, 3 minor amputations on toes 
or forefoot, 1 case of 30-day cardiac complications (myocardial infarction or arrhythmia). There was 
no significant difference in amputation, overall morbidity, or mortality rates between the two surgical 
graft populations, and the rate of limb salvage was not significantly different for the two graft 
materials. Results has also shown that the most significant predictors of early graft failure were 
diabetes mellitus and critical limb ischaemia. 
This study showed that Dacron grafts may be at least as durable as ePTFE for above-knee bypass 
procedures, and might even be superior.  
This study supports the use of knitted prosthetic grafts (POLYMAILLE® C) for the replacement of 
peripheral arteries during peripheral atherosclerotic arterial disease and collects the performance of 
vascular grafts (primary patency) up to 2 years of follow-up. This study also provides safety 
information. 
Clinical survey (unpublished) 
PEROUSE MEDICAL conducted a multicentre, non-prospective, non-comparative post-marking 
evaluation using evaluation questionnaires where the POLYMAILLE® C vascular graft was evaluated 
(NPCI 2009, Manufacturer’s own report). The aim of this investigation was to evaluate the 
characteristics of the POLYMAILLE® C vascular graft by surgeons, in terms of comfort and ease of use 
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TITLE: 
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Safety and Performance of POLYMAILLE® C vascular prosthesis 
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(suppleness, conformability, clean and safe cutting with scissors, ideal suturability, optimal 
circumferential stability).  
From May 2008 to February 2009, 88 implanted POLYMAILLE® C vascular grafts have been included in 
this clinical survey. No inclusion or exclusion criteria were imposed. This clinical survey was conducted 
in 4 countries: Italia, Austria, Czech Republic and Belgium. There were no follow-up visits of implanted 
patients, as the aim of this survey was the assessment of the peri-operative prosthesis characteristics 
(before implantation, during implantation and after blood flow restoration).  
As results from the questionnaire, it was concluded that: main interventions were elective (75%) with 
conventional surgery; interventions were conducted in the abdominal site or peripheral site (no 
thoracic use); bifurcated prosthesis was preferred (85.7%) for the abdominal site, while straight 
prosthesis was preferred (91.7%) for the peripheral site. This survey did not mention patient’s data, 
therefore indication of prosthesis (aneurysmal or obliterative arteries) is not reported. 
Surgeons considered the sensation (touch) of POLYMAILLE® C graft as excellent or good (97.7%), 
similarly to the suppleness (93.2%) and the ease of cutting (97.7%).  
During the implantation, 94.3% considered the anastomotic conformability as excellent or good, 
similarly to the suturability (95.4%). Proximal anastomosis (both terminal and lateral) was easily 
performed as rated by 98.9% of the surgeons. Similarly, the distal anastomosis was considered easy to 
perform by 96.6% of the surgeons. The most frequent needles used in suture were round in both 
proximal and distal anastomosis (86.4% and 76.1% respectively). Comfort of POLYMAILLE® C vascular 
grafts was considered as excellent or good by 84.1% of surgeons (against 7.9% who considered the 
comfort as average or insufficient).  
Difficulties during implantation were reported from one centre: leakage of graft beneath bifurcation, 
twisted markings of the graft, torsion of the graft in the canal of Hunter, bleeding of the graft.  
After blood flow restoration: the general appearance was considered as excellent or good in 98.8% of 
cases; the limited circumferential dilatation and the longitudinal elongation were assessed as excellent 
or good (95.4% in both cases). Despite some cases of leakage of graft beneath bifurcation, torsion of 
the prosthesis in the canal of Hunter and bleeding of the graft, it was reported that the blood tightness 
of the graft was excellent or good in 95.5% of cases, and similar results were recorded for the blood 
tightness of the anastomoses (93.1%).  
Regarding safety, among the 88 implanted patients, only 3 complications (3.4%) were reported during 
the intervention (1 bleeding, 1 cardiorespiratory failure leading to patient’s death the day after, 1 
operative re-anastomosis from external iliac to common femoral artery).  
Following this NPCI evaluation questionnaire, it was concluded that POLYMAILLE® C was associated 
with high level of comfort and ease of use during conventional surgery. This clinical survey also 
supports the use of knitted prosthetic grafts for the replacement of abdominal and peripheral arteries. 
This clinical survey may be adapted to procedural success, however, it does not support long-term 
performance and safety of the prosthesis, as only peri-operative data were available. 
This study supports the use of knitted prosthetic grafts (POLYMAILLE® C) for the replacement of 
abdominal and peripheral arteries and confirms the performance of vascular grafts (procedural 
success) in peri-operative period. This study also provides peri-operative safety information. 
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TITLE: 
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Safety and Performance of POLYMAILLE® C vascular prosthesis 
EFFECTIVE DATE: 
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Vigilance data  
An ad hoc analysis of sales and complaints was obtained for the sixteen-year time period since January 
2004. During that period more than 55 000 POLYMAILLE® C devices were sold. During the same time 
period a total of 37 complaints were reported yielding an overall complaint rate of 0.066% of 
POLYMAILLE® C (Manufacturer’s data).  
5.2. Rationale for PMCF study 
Available evidence confirms acceptability of performance and side effects related to POLYMAILLE® C; 
however intended claims on clinical safety and performance are not sufficiently supported with 
existing clinical evidence, especially for long term assessment and for abdominal surgical locations. In 
order to keep POLYMAILLE® C 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 POLYMAILLE® C 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 POLYMAILLE® C implanted for at least one year and up to 5 years 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 200 from 3 to 8 different sites in France will be evaluated. A minimum of 100 
subjects will be evaluated for each main location of surgery (peripheral and abdominal). 
Not more than 50% of study total enrolled subjects shall pertain to one unique centre.  
5.3.1. Inclusion criteria  
Patients must meet all 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  
Patients who have objected to the collect of their data.  
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TITLE: 
2020-PMC-01  
Safety and Performance of POLYMAILLE® C vascular prosthesis 
EFFECTIVE DATE: 
15 January 2021 
 
 
 
 
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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 analyze already collected data. 
There is no anticipated additional clinical benefit expected from the use of POLYMAILLE® C 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 abdominal and peripheral arteries.  
Replacement or bypass of arteries presenting obliterative arterial disease (PAD) 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 aneurysmal disease is required to exclude the 
aneurysmal part without compromising the blood flow to distal tissues. Anticipated clinical benefits 
may consist in reduced risks of aneurysm associated thrombotic 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 POLYMAILLE® C devices include:  
- 
Bleeding 
- 
Hematoma  
- 
Adherence to surrounding tissues  
- 
Allergic reaction  
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PROTOCOL 
TITLE: 
2020-PMC-01  
Safety and Performance of POLYMAILLE® C vascular prosthesis 
EFFECTIVE DATE: 
15 January 2021 
 
 
 
 
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- 
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  
- 
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 POLYMAILLE® C study is to describe safety and performance of 
POLYMAILLE® C. 
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 POLYMAILLE® C, 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 
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PROTOCOL 
TITLE: 
2020-PMC-01  
Safety and Performance of POLYMAILLE® C vascular prosthesis 
EFFECTIVE DATE: 
15 January 2021 
 
 
 
 
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* Primary endpoint 
**Listed in section 6.2 
 
 
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7.1. Performance endpoints 
- 
Primary performance endpoint is primary patency rate at 1 year after surgery using 
POLYMAILLE® C.  
- 
The others performance 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. 
- 
Primary patency rate, defined as rate of patent grafts without any procedure or 
intervention of the conduit itself  
- 
Primary assisted patency rate, defined as rate of patent grafts, with or without 
procedure or intervention of the conduit itself after device implantation, such as 
endovascular balloon angioplasty or anastomotic revision, however with graft 
never thrombosed (graft occlusion) 
- 
Secondary patency rate, defined as rate of patent grafts, with or without procedure 
or intervention of the conduit itself after device implantation, such as endovascular 
balloon angioplasty or anastomotic revision, lysis and/or thrombectomy.  
- 
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 rate at 30 days after surgery using POLYMAILLE® C.  
- 
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.   
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Safety and Performance of POLYMAILLE® C vascular prosthesis 
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15 January 2021 
 
 
 
 
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8. STATISTICAL CONSIDERATIONS  
8.1. Statistical design, method and analytical procedures 
All the 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 by the 2 sub-populations. Results will be stratified 
according to 2 main surgical locations: 
 
Abdominal surgical location: 
o  Aorto-aortic and/or aorto-iliac and/or aorto-femoral repair  
 
Peripheral surgical location:  
o Peripheral artery repair and extra anatomic bypasses  
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 observations) will be tabulated as a separate category. If the % of missing data does 
not exceed 10 %, 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. 
8.2. Sample size justification 
Data from a minimum of 200 subjects will be evaluated. A minimum of 100 subjects will be evaluated 
for each main location of surgery (abdominal and peripheral). 
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TITLE: 
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Safety and Performance of POLYMAILLE® C vascular prosthesis 
EFFECTIVE DATE: 
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The number of patients has been chosen in accordance with the realistic number of operated patients 
in the involved hospitals. 
 
 
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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 
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 effectiveness. 
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 
 
Date 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, hyperlipidemia, 
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); 
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Safety and Performance of POLYMAILLE® C vascular prosthesis 
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 
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 
 
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) 
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Safety and Performance of POLYMAILLE® C vascular prosthesis 
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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 
 
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. 
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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.  
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 the CIP 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.  
 
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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. 
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. 
 
 
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18. BIBLIOGRAPHY 
1. Elbarbary A. Dacron or Polytetrafluoroethylene for Above-knee Femoropopliteal Bypass. Ain 
Shams Journal of Surgery. 2014 Nov 1; 
 
2. MPH ANSM, MBA BAPM. Rutherford’s Vascular Surgery and Endovascular Therapy, 2-Volume 
Set. 9th edition. Philadelphia, PA: Elsevier; 2018. 2832 p. 
3. Clinical Evaluation Report – Woven [Polythese®] or knitted [Polymaille®] Vascular Prostheses 
coated with bovine collagen. NAMSA n°FR005044-002. 2020.  
  
 
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