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

NCT ID: NCT03173703

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-13
• Study Completion Date: 2025-11-15

Brief 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

Vascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test Arm

Test Arm are subjects to be implanted with test article -XenoSure patch. The interventions include: Repair/reconstruction of the diseased vessel; Implant the XenoSure patch

Group Type: EXPERIMENTAL

Implant the XenoSure patch

Intervention Type: DEVICE

The LeMaitre XenoSure patch will be used when close the repaired vessel

Repair/reconstruction of the diseased vessel

Intervention Type: PROCEDURE

The diseased vessel is surgically repaired such as removing the clots.

Control Arm

Test Arm are subjects to be implanted with B. Braun's Vascular-Patch.The interventions include: Repair/reconstruction of the diseased vessel; Implant the Vascular-Patch.

Group Type: ACTIVE_COMPARATOR

Repair/reconstruction of the diseased vessel

Intervention Type: PROCEDURE

The diseased vessel is surgically repaired such as removing the clots.

Implant the Vascular-Patch

Intervention Type: DEVICE

The B. Braun Vascular-Patch will be used when close the repaired vessel

Interventions

Implant the XenoSure patch

The LeMaitre XenoSure patch will be used when close the repaired vessel

Intervention Type: DEVICE

Repair/reconstruction of the diseased vessel

The diseased vessel is surgically repaired such as removing the clots.

Intervention Type: PROCEDURE

Implant the Vascular-Patch

The B. Braun Vascular-Patch will be used when close the repaired vessel

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 1) Any man or woman aged between 18~80 years old 2) The expected lifetime of no less than 12 months 3) The subject can be considered for suturing with XenoSure Biological Patch after the peripheral vascular repair surgery. The subject's targeted arterial diameter is less than 5mm or the arterial incision length is more than 4cm and less than 9cm.

4) Physical conditions and vital signs meet requirements for the surgery. 5) The subjects and/or their guardians sign the written Informed Consent Form.

Exclusion Criteria

1. Patients with severe visceral diseases in heart, liver, kidney, etc.

2. Patients have unstable vital signs and not suitable for the surgery indications

3. Patients need vascular outflow stenting repair in the same location with XenoSure® Biological Patch.

4. Pregnant or lactating women

5. Patients With severe allergic history (especially allergic to bovine materials)

6. Patients with the past medical history of severe immunodeficiency disease

7. The subject has used or plans to use immunomodulatory drugs for more than half a year.

8. The subject with poor blood clotting function is defined as that pre-operative INR or APTT is prolonged over 30% than the reference value without drug intervention, or that blood platelet count is less than 100*10^9/L.

9. The subject has severe kidney disorders or diseases with the estimated glomerular filtration rate [GRF]<30mL/min/1.73m2.

10. The subject's ALT or AST level is 2.5 times higher than the upper normal limit or the subject has active liver disease or icterus.

11. The subject has participated in another clinical study within 3 months or is participating in another clinical study now.

12. The investigator believes that the subject has other reasons unsuitable for inclusion.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LeMaitre Vascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hua Shan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

P15077-2

Identifier Type: -

Identifier Source: org_study_id