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

NCT03173703 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-03-10

No results posted yet for this study

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.

Conditions

  • Vascular Diseases

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

Sponsors & Collaborators

  • LeMaitre Vascular

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-13
Primary Completion
2025-11-15
Completion
2025-11-15
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03173703 on ClinicalTrials.gov