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 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT03477604
Eligibility Criteria:
General Inclusion Criteria:
1. Subject is a male or a non-pregnant female adult between the age of 21 and 90 years old.
2. Subject has documented clinical evidence of critical limb ischemia (CLI) in the target limb prior to the index procedure, with a Rutherford Classification score of 4-5.
3. The subject, or subject's designated legal representative, has been informed of the nature of the study and is willing to provide written informed consent.
4. Subject is willing to comply with all required follow-up visits.
5. Subject life expectancy is ≥1 year per the Principal Investigator.
Angiographic Inclusion Criteria
6. Target vessel reconstitutes at or above the ankle with inline flow to at least one patent (\<50% stenosis) inframalleolar outflow vessel.
7. Subject has a lesion, with ≥ 70% stenosis and ≤ 12.0 cm in length located at or distal to the tibial-peroneal trunk and above the tibiotalar joint; including the anterior tibial, posterior tibial or peroneal arteries.
8. Target lesion has a reference vessel diameter of 2.5 - 4.5 mm
9. The target lesion is able to be crossed with a guidewire to facilitate treatment with the randomized device.
General Exclusion Criteria:
1. Subject had a prior or has a planned index limb amputation above the ankle.
2. Subject has a wound/ulcer on the forefoot with a surface area \>4cm² or osteomyelitis involving the calcaneus bone.
3. Subject is pregnant, plans to become pregnant, or is nursing.
4. Subject has clinical conditions that severely inhibit X-ray or duplex ultrasound visualization (e.g. body habitus).
5. Subject has a history of hypercoagulation/clotting disorders or acute thrombosis.
6. Subject has allergy to iodinated contrast media that cannot be adequately managed with medication.
7. Subject is in acute renal failure.
8. Subject has an active systemic infection.
9. Subject is participating in another research study involving an investigational device, biologic, or drug that has not completed the primary endpoint at the time of randomization/enrollment.
10. Subject has other comorbidities that - in the opinion of the investigator - preclude them from receiving study treatment and/or from completing the required study follow-up assessments.
11. Subject presents with acute limb ischemia or acute thrombosis of the target limb.
12. Subject has experienced myocardial infarction, thrombolysis, or angina less than 30 days prior to the index procedure.
13. Subject had a stroke within 3 months of index procedure.
Angiographic exclusion criteria
14. Failure to successfully treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries. Successful treatment is defined as obtaining ≤30% residual stenosis with no major procedural complications (e.g embolism).
15. Failure to successfully treat significant non-target infra-popliteal lesions. Successful treatment is defined as obtaining ≤30% residual stenosis with no major procedural complications (e.g. embolism).
16. Target lesion is within a previously placed stent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03477604
Study Brief:
Protocol Section:
NCT03477604