Trials / Active Not Recruiting
Active Not RecruitingNCT03173703
Evaluate Safety and Effectiveness of XenoSure® Biological Patch in the Application of Peripheral Vascular Repair
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
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- Sponsor
- LeMaitre Vascular · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2017-07-13
- Primary completion
- 2025-11-15
- Completion
- 2025-11-15
- First posted
- 2017-06-02
- Last updated
- 2025-03-10
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03173703. Inclusion in this directory is not an endorsement.