Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT03173703
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:
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.
\-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03173703
Study Brief:
Protocol Section:
NCT03173703