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

Perouse Medical

Status: Completed

Conditions: Artery Stenosis, Carotid; Stroke; Artery Stenosis; Occlusion of Artery

Treatments: Device: Endarterectomy

Study type: Observational

Funder types: Industry

Identifiers

NCT04643743

2020-POL-01

Details and patient eligibility

About

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.

Enrollment: 198 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

198 participants in 1 patient group

Subjects who did receive POLYPATCH® for vascular angioplasty

Description:

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.

Treatment:

Device: Endarterectomy