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:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT05361967
Eligibility Criteria:
Inclusion Criteria:
General Inclusion Criteria
1. Age ≥ 18 years
2. Willingness to comply with study follow-up evaluations at the predefined time intervals
3. Signs the written informed consent
4. Meets Rutherford classification criteria:
1. ATK subjects can be RCC 3, 4 or 5
2. BTK subjects must be RCC 4 or 5
Angiographic Inclusion Criteria
1. A de novo or restenotic, non-stented target lesion with pre-intervention stenosis or occlusion (by visual estimate)
2. ATK Lesions:
1. must be in the superficial femoral and/or proximal popliteal (P1) arteries and
2. have a reference vessel diameter range of 3.5-6.0mm or 4.0-8.0mm.
3. BTK Lesions:
1. must be in the mid/distal popliteal (P2/P3), peroneal and/or tibial arteries and
2. have a reference vessel diameter range of 1.5-4.5mm Note: The mid popliteal artery begins at the superior aspect of the patella.
Post-IVUS Inclusion Criteria
1. Presence of an arterial dissection requiring repair per investigator judgement
2. ATK reference vessel diameter range of 3.5-6.0mm or 4.0-8.0mm
3. BTK reference vessel diameter range of 1.5-4.5mm
Exclusion Criteria:
General Exclusion Criteria
1. Subject is known to be breastfeeding, pregnant or planning to become pregnant during the study
2. Anticipated life expectancy \< 12 months
3. Known COVID positive test within 14 days and active symptoms
4. Known renal disease that precludes contrast administration
5. Presence of a wound that in the opinion of the investigator cannot be healed with transmetatarsal amputation (TMA)
6. Contraindication to anticoagulation and/or antiplatelet therapy
7. Known allergy to nitinol (nickel and/or titanium)
8. Known allergy to contrast media that cannot be adequately pre-medicated prior to index procedure
9. Previous or planned surgical or interventional procedure within 3 days before or 30 days after the index procedure.
Note: this excludes successful inflow artery treatment within the same hospitalization or a documented pre-planned minor amputation.
10. Subject has any condition that in the opinion of the investigator precludes the subject from participation
Angiographic Exclusion Criteria
1. Residual diameter stenosis ≥30% (visual estimate) after PTA
2. Aneurysm, acute or sub-acute thrombosis in target lesion
3. Acute vessel occlusion after PTA not attributed to dissection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05361967
Study Brief:
Protocol Section:
NCT05361967