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

NCT03173703 | Active Not Recruiting DMC FDA Device

• 1 other identifier: P15077-2
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

Test Arm

EXPERIMENTAL

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

Device: Implant the XenoSure patch; Procedure: Repair/reconstruction of the diseased vessel

Control Arm

ACTIVE COMPARATOR

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.

Procedure: Repair/reconstruction of the diseased vessel; Device: Implant the Vascular-Patch

Interventions

Implant the XenoSure patch DEVICE

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

Test Arm

Repair/reconstruction of the diseased vessel PROCEDURE

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

Control Arm; Test Arm

Implant the Vascular-Patch DEVICE

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

Control Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with severe visceral diseases in heart, liver, kidney, etc.
• Patients have unstable vital signs and not suitable for the surgery indications
• Patients need vascular outflow stenting repair in the same location with XenoSure® Biological Patch.
• Pregnant or lactating women
• Patients With severe allergic history (especially allergic to bovine materials)
• Patients with the past medical history of severe immunodeficiency disease
• The subject has used or plans to use immunomodulatory drugs for more than half a year.
• 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.
• The subject has severe kidney disorders or diseases with the estimated glomerular filtration rate \[GRF\]\<30mL/min/1.73m2.
• 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.
• The subject has participated in another clinical study within 3 months or is participating in another clinical study now.

Sponsors & Collaborators

• LeMaitre Vascular: lead

Study Sites (1)

Hua Shan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Vascular Diseases

Interventions

Wound Healing

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: June 2, 2017
• Study Start: July 13, 2017
• Primary Completion: November 15, 2025
• Study Completion: November 15, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)