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ACTIVE NOT RECRUITING
NCT03173703
NA

Evaluate Safety and Effectiveness of XenoSure® Biological Patch in the Application of Peripheral Vascular Repair

Sponsor: LeMaitre Vascular

View on ClinicalTrials.gov

Summary

The purpose of this trial is to collect safety and effectiveness data to support peripheral vascular indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulation in this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.

Official title: Random, Controlled, Single-blinded, Multi-center and Non-inferiority Clinical Study to Evaluate Safety and Effectiveness of XenoSure® Biological Patch in the Application of Peripheral Vascular Repair

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2017-07-13

Completion Date

2025-11-15

Last Updated

2025-03-10

Healthy Volunteers

No

Interventions

DEVICE

Implant the XenoSure patch

The LeMaitre XenoSure patch will be used when close the repaired vessel

PROCEDURE

Repair/reconstruction of the diseased vessel

The diseased vessel is surgically repaired such as removing the clots.

DEVICE

Implant the Vascular-Patch

The B. Braun Vascular-Patch will be used when close the repaired vessel

Locations (1)

Hua Shan Hospital

Shanghai, Shanghai Municipality, China