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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Vascular Diseases
• Intervention / Treatment: Device: Implant the XenoSure patch; Procedure: Repair/reconstruction of the diseased vessel; Device: Implant the Vascular-Patch

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.

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Hua Shan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: LeMaitre Vascular

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2017
• Primary Completion (Estimated): November 15, 2024
• Study Completion (Estimated): November 15, 2024

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: P15077-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes