Vascular Diseases
Conditions
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
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.
Interventions
DEVICEImplant the XenoSure patch
The LeMaitre XenoSure patch will be used when close the repaired vessel
PROCEDURERepair/reconstruction of the diseased vessel
The diseased vessel is surgically repaired such as removing the clots.
DEVICEImplant the Vascular-Patch
The B. Braun Vascular-Patch will be used when close the repaired vessel
Sponsors
LeMaitre Vascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency measured by ultrasound | 6 months | 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. |
Countries
China
Outcome results
None listed