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

LeMaitre Vascular

Status: Active, not recruiting

Conditions: Vascular Diseases

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03173703

P15077-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 2 patient groups

Test Arm

Experimental group

Description:

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

Treatment:

Device: Implant the XenoSure patch

Procedure: Repair/reconstruction of the diseased vessel

Control Arm

Active Comparator group

Description:

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.

Treatment:

Device: Implant the Vascular-Patch

Procedure: Repair/reconstruction of the diseased vessel