Study of the AFB and Stenting of the Iliac Arteries

Phase 1

Completed

• Conditions: Aorta-iliac Segment Lesion (C,D Type by TASC II)
• Interventions: Procedure: Aorta-femoral bypass; Procedure: Recanalization and stenting of aorta-iliac segment

• Registration Number: NCT02209350
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-30
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-05
• Study Start: 2015-08-02
• Primary Completion: 2020-11-01
• Study Completion: 2020-11-02
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-12
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Aorta-femoral bypass	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).
Group 2	Recanalization and stenting of aorta-iliac segment	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).

Primary Outcome Measures

Name	Time	Method
30-day secondary patency rates	30-day	during the whole 30 days from the date of intervention. confirmation of patency of the arterial ultrasound of the operated segment after reintervention due to thrombosis
Technical success	1 day	Successful implantation of all devices without the need for conversion and with residual stenosis less than 30%
30-day complication rate	30 days	clinically significant bleeding, hematoma, infection of the prosthesis, infection of postoperative wound, lymphorrhea, renal failure, myocardial infarction, stroke, mortality, thrombosis of the operated segment, distal embolism
30-day primary patency rates	30 days	during the whole 30 days from the date of intervention. confirmation of patency of the arterial ultrasound of the operated segment.

Secondary Outcome Measures

Name	Time	Method
Limb salvage	36 months	preservation of a functional foot, eliminating the necessity for major amputation
Primary patency rates	36 months	no occlusion or significant flow-limiting stenosis in the treated segment
Major adverse cardiovascular event (MACE)	36 months	composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
Amputation-free survival	36 months	freedom from major limb amputation or death by any cause
Secondary patency rates	36 months	no occlusion or flow-limiting stenosis following at least one re-intervention aimed at restoring patency, in addition to all instances of primary patency

Trial Locations

Locations (1)

Novosibirsk Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation