Status:
COMPLETED
Study of the AFB and Stenting of the Iliac Arteries
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Conditions:
Aorta-iliac Segment Lesion (C,D Type by TASC II)
Eligibility:
All Genders
45-75 years
Phase:
PHASE1
Brief Summary
The aim of the study is to compare effectiveness and long-term results of aorta-femoral reconstructions and endovascular treatment in the patients with aorta-iliac lesions (TASC C,D).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 2 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2020
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT02209350
Start Date
August 2 2015
End Date
November 2 2020
Last Update
January 15 2025
Active Locations (1)
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1
Novosibirsk Research Institute of Circulation Pathology
Novosibirsk, Russia, 630055