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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

198 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-06-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Artery Stenosis, Carotid Artery Stenosis Occlusion of Artery Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Endarterectomy

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE