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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Artery Stenosis; Artery Stenosis, Carotid; Occlusion of Artery
• Intervention / Treatment: Device: Endarterectomy

• Study Type: Observational
• Enrollment (Actual): 198

Contacts and Locations

Study Locations

• France
  • Paris, France, 75017
    • Eclevar Medtech

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The investigators will screen all potential subjects and will select those who are appropriate for study inclusion, i.e. adult subjects implanted with POLYPATCH® for at least one year.

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects who did receive POLYPATCH® for vascular angioplasty; 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.	Device: Endarterectomy; Endarterectomy is a surgical procedure to remove the atheromatous plaque material, or blockage, in the lining of an artery constricted by the buildup of deposits. It is carried out by separating the plaque from the arterial wall.; Other Names: Carotid Endarterectomy; Femoral Endarterectomy; Patch Angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change rate of restenosis	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®	within 30 days after surgery and long term (up to 1 year after surgery )

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success rate	ability to use with no need for using another device,; effective vascular closure after endarterectomy procedure,; no need to re-operate before patient discharge	within 30 days after surgery and long term (up to 1 year after surgery )
target-artery restenosis Target-artery restenosis	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.	within 30 days after surgery and long term (up to 3 years)
target-artery re-intervention	angioplasty and stenting,; surgical bypass,; thrombectomy and re-do patchoplasty,; evacuation of hematoma.	within 30 days after surgery and long term (up to 3 years)
stroke (ipsilateral and any)	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	within 30 days after surgery and long term (up to 3 years)
transient ischemic attack	within 30 days after surgery and long term (up to 3 years)	3 years
myocardial infarction	within 30 days after surgery and long term (up to 3 years)	3 years
mortality (cardiovascular and all causes)	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	within 30 days after surgery and long term (up to 3 years)
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)
Operation time		up to 24 weeks

Collaborators and Investigators

• Sponsor: Perouse Medical
• Collaborators: Eclevar Medtech
• Investigators: Study Director: Armel Plaine, Master, Eclevar Medtech

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ACTUAL): June 10, 2022
• Study Completion (ACTUAL): June 10, 2022

Study Registration Dates

• First Submitted: November 1, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (ACTUAL): November 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: carotid endarterectomy; Thrombosis; vascular patch; Polypatch; femoral endarterectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Artery Diseases; Carotid Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 2020-POL-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No