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Evaluate Safety and Effectiveness of XenoSure® Biological Patch in the Application of Peripheral Vascular Repair
Sponsor: LeMaitre Vascular
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
Conditions
Interventions
Implant the XenoSure patch
The LeMaitre XenoSure patch will be used when close the repaired vessel
Repair/reconstruction of the diseased vessel
The diseased vessel is surgically repaired such as removing the clots.
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