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

Primary Purpose

Vascular Diseases

Status

Active

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Implant the XenoSure patch

Repair/reconstruction of the diseased vessel

Implant the Vascular-Patch

About this trial

This is an interventional treatment trial for Vascular Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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:

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

Sites / Locations

Hua Shan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Arm

Control Arm

Arm 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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03173703

First Posted

May 25, 2017

Last Updated

November 28, 2022

Sponsor

LeMaitre Vascular

1. Study Identification

Unique Protocol Identification Number

NCT03173703

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 13, 2017 (Actual)

Primary Completion Date

November 15, 2023 (Anticipated)

Study Completion Date

June 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LeMaitre Vascular

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vascular Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Test Arm

Arm Type

Experimental

Arm 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

Arm Title

Control Arm

Arm Type

Active Comparator

Arm 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.

Intervention Type

Device

Intervention Name(s)

Implant the XenoSure patch

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Repair/reconstruction of the diseased vessel

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Implant the Vascular-Patch

Intervention Description

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

Primary Outcome Measure Information:

Title

Primary patency measured by ultrasound

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Hua Shan Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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