A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch

Completed

• Conditions: Occlusion of Artery; Artery Stenosis, Carotid; Artery Stenosis; Stroke
• Interventions: Device: Endarterectomy

• Registration Number: NCT04643743
• Lead Sponsor: Perouse Medical

Brief Summary

POLYPATCH® study is RWE multicentre study which examine short and long-term outcomes of using POLYPATCH® when exposed to a larger and more varied population.

All data will be retrieved from medical charts for each patient from time of surgery (considered as baseline of study) until a maximum of 3 years after surgery.

A minimum of 250 up to a maximum of 300 subjects will be evaluated from 3 to 8 different sites. At least 100 subjects will be evaluated in carotid location and at least 100 in femoral location.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-11-01
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-25
• Primary Completion: 2022-06-10
• Study Completion: 2022-06-10
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• Subjects who did receive POLYPATCH® at least one year ago for vascular angioplasty
• Subjects ≥ 18 years old

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects who did receive POLYPATCH® for vascular angioplasty	Endarterectomy	Subjects who did receive POLYPATCH® at least one year ago for vascular angioplasty. 2 main sub-populations will be studied depending on location of surgery (carotid and femoral) but data will be collected for all subjects who did receive POLYPATCH.

Primary Outcome Measures

Name	Time	Method
Change rate of restenosis	within 30 days after surgery and long term (up to 1 year after surgery )	Measure assessing change target-artery restenosis (defined as 70% or more diameter-reducing stenosis), occlusion, or re-intervention within 1 year after surgery using POLYPATCH®

Secondary Outcome Measures

Name	Time	Method
transient ischemic attack	3 years	within 30 days after surgery and long term (up to 3 years)
Operation time	up to 24 weeks
myocardial infarction	3 years	within 30 days after surgery and long term (up to 3 years)
Procedural success rate	within 30 days after surgery and long term (up to 1 year after surgery )	* ability to use with no need for using another device,; * effective vascular closure after endarterectomy procedure,; * no need to re-operate before patient discharge
target-artery restenosis Target-artery restenosis	within 30 days after surgery and long term (up to 3 years)	Restenosis can be identified by echo-doppler, CT scan or angiography evaluating the percentage of lumen of vessel but can also be classified as symptomatic vs asymptomatic and/or requiring or not re-intervention.
target-artery re-intervention	within 30 days after surgery and long term (up to 3 years)	* angioplasty and stenting,; * surgical bypass,; * thrombectomy and re-do patchoplasty,; * evacuation of hematoma.
stroke (ipsilateral and any)	within 30 days after surgery and long term (up to 3 years)	Stroke is a risk inherent to any surgical intervention, especially vascular surgeries. Although uncommon, stroke in the perioperative period is associated with significant morbidity and mortality in the CEA patient population
mortality (cardiovascular and all causes)	within 30 days after surgery and long term (up to 3 years)	Death is the most dramatic complication one can encounter after vascular procedure. It can result from ipsilateral stroke caused by restenosis or thrombi, patch rupture caused by patch infection, or secondary cardiovascular or neurologic risks caused by the surgery itself
occurrence of other complications	within 30 days after surgery and long term (up to 3 years)	within 30 days after surgery and long term (up to 3 years)

Trial Locations

Locations (1)

Eclevar Medtech; 🇫🇷 Paris, France