Skip to main content
OpenTrials
Completed

NCT Number: NCT04643743

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Artery Stenosis, Carotid Arterial Occlusive Diseases Artery Stenosis Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Nervous System Diseases Occlusion of Artery Stroke Thrombosis Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eclevar Medtech

Paris, 75017, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Endarterectomy

Device

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

Primary outcomes

  1. Change rate of restenosis

    Time frame: 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 outcomes

  1. Procedural success rate

    Time frame: 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

  2. target-artery restenosis Target-artery restenosis

    Time frame: 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.

  3. target-artery re-intervention

    Time frame: 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.

  4. stroke (ipsilateral and any)

    Time frame: 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

  5. transient ischemic attack

    Time frame: 3 years

    within 30 days after surgery and long term (up to 3 years)

  6. myocardial infarction

    Time frame: 3 years

    within 30 days after surgery and long term (up to 3 years)

  7. mortality (cardiovascular and all causes)

    Time frame: 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

  8. occurrence of other complications

    Time frame: within 30 days after surgery and long term (up to 3 years)

    within 30 days after surgery and long term (up to 3 years)

  9. Operation time

    Time frame: up to 24 weeks

Sponsors and collaborators

Lead sponsor

Perouse Medical

Industry

Collaborators

  • Eclevar Medtech

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 25, 2020
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.