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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
144
The LeMaitre XenoSure patch will be used when close the repaired vessel
The diseased vessel is surgically repaired such as removing the clots.
The B. Braun Vascular-Patch will be used when close the repaired vessel
Hua Shan Hospital
Shanghai, Shanghai Municipality, China
Primary patency measured by ultrasound
The treated vessel is considered "patent" if the re-narrowing of the ID of the vessel is less than 20% of the ID that measured immediately after procedure. The study is considered achieved its primary endpoint if the primary patency rate of test device is non-inferior to the rate of the comparator device.
Time frame: 6 months
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