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Clinical Trials in China / NCT03173703
Active, not recruiting Not applicable

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

NCT03173703 · tracked via the Priya Life Science China tracker
Sponsor
LeMaitre Vascular
Phase
Not applicable
Started
2017-07-13
Last updated
2025-03-10

Condition(s) studied

Vascular Diseases

Investigational drug(s) / intervention(s)

Implant the XenoSure patchRepair/reconstruction of the diseased vesselImplant the Vascular-Patch

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

Repair/reconstruction of the diseased vessel: The diseased vessel is surgically repaired such as removing the clots.

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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. \-

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hua Shan Hospital Shanghai Shanghai Municipality

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03173703 on ClinicalTrials.gov ↗ ← All trials in China