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

NCT04643743 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 198

Last updated 2022-08-24

No results posted yet for this study

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.

Conditions

  • Artery Stenosis, Carotid
  • Artery Stenosis
  • Occlusion of Artery
  • Stroke

Interventions

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.

Sponsors & Collaborators

  • Eclevar Medtech

    collaborator INDUSTRY

  • Perouse Medical

    lead INDUSTRY

Principal Investigators

  • Armel Plaine, Master · Eclevar Medtech

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-06-10
Completion
2022-06-10
FDA Device
Yes

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04643743 on ClinicalTrials.gov