Last updated on March 2019

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


Brief description of study

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.

Detailed Study Description

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.

144 subjects for peripheral vascular repair, including respective 72 subjects for the trial group and the control group.

Clinical Study Identifier: NCT03173703

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Recruitment Status: Open


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