NCT04643743

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 198 (actual)
• Sponsor: Perouse Medical · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-06-10
• Completion: 2022-06-10
• First posted: 2020-11-25
• Last updated: 2022-08-24

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated device study