Study of the AFB and Stenting of the Iliac Arteries

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Completed; Phase 1

Conditions: Aorta-iliac Segment Lesion (C,D Type by TASC II)

Treatments: Procedure: Aorta-femoral bypass; Drug: Therapy: aspirin and clopidogrel; Procedure: Recanalization and stenting of aorta-iliac segment

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02209350

TASC C,D

Details and patient eligibility

About

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).

Enrollment: 202 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Operations technique on the abdominal aorta. Aorta-femoral bypass. Medication: after surgery all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).

Treatment:

Drug: Therapy: aspirin and clopidogrel

Procedure: Aorta-femoral bypass

Group 2

Active Comparator group

Description:

Standard endovascular treatment (stenting) in patients with the iliac segment occlusive disease. Medication: after stenting all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).

Treatment:

Procedure: Recanalization and stenting of aorta-iliac segment

Drug: Therapy: aspirin and clopidogrel