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 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT02209350
Eligibility Criteria:
Inclusion Criteria:
* Patients with unilateral steno-occlusive iliac lesions (TASC types C, D) and with chronic lower limb ischemia
* Rutherford classification category 3-5 chronic limb ischemia,
* age: 45-75 years old.
* Patients who consented to participate in this study.
Exclusion Criteria:
* Aortic thrombosis, concomitant abdominal aortic or iliac aneurysms, acute limb ischemia or vasculitis;
* Flush occlusion of the common iliac artery;
* Ipsilateral common femoral arteries steno-occlusive disease (occlusion or stenosis \>50%);
* Ipsilateral profunda femoris artery steno-occlusive disease (occlusion or stenosis \>50%);
* Refusal to participate in the study;
* Stroke or myocardial infarction within the past 3 months;
* Ischemic heart disease with New York Heart Association functional class IV;
* Malignant tumor with an estimated life span of under 6 months;
* Previous ipsilateral or contralateral surgery (bypass, hybrid or stenting);
* Hepatic or renal insufficiency (bilirubin\> 35 mmol/l, glomerular filtration rate \<60 ml/min/1.73 m2);
* Severe calcification of the aorta and iliac arteries intolerant to balloon angioplasty (as determined by the Peripheral Arterial Calcification Scoring System on computed tomography angiography as interpreted by a vascular radiologist):12
* unilateral calcification ≥ 5cm (Grade 2), bilateral calcification ≥ 5cm (Grade 4) or circumferential calcification , defined as 270°-360° around the circumference of aorta and/or iliac arteries.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT02209350
Study Brief:
Protocol Section:
NCT02209350