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 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT04442802
Eligibility Criteria:
Inclusion Criteria:
1. Chronic limb threatening ischemia category 4-6 according to Rutherford classification;
2. Ankle-brachial index \<0.8 or \>1.4
3. Clinical stage ≥2 of WIfI (Wound, Ischemia, foot Infection) classification;
4. Stenosis of ≥50% or occlusion in superficial femoral or popliteal artery, confirmed by duplex ultrasound, computer tomography angiography or digital subtraction angiography;
5. Use of endovascular approach for treatment of the lesion;
6. Patient willing to sign informed consent.
Exclusion Criteria:
1. Acute arterial occlusion (symptoms duration less than 14 days);
2. Recurrent stenosis or occlusion of femoropopliteal segment;
3. Impossibility to cross the lesion intraluminally during the endovascular intervention;
4. Life expectancy of less than 1 year -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04442802
Study Brief:
Protocol Section:
NCT04442802