Study of the AFB and Stenting of the Iliac Arteries

Prospective Randomized Clinical Study of the Aorto-femoral Bypass and the Iliac Arteries With Stenting Recanalization Effectiveness in Patients With the Iliac Segment Occlusive Disease

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).

Study Overview

• Status: Completed
• Conditions: Aorta-iliac Segment Lesion (C,D Type by TASC II)
• Intervention / Treatment: Procedure: Aorta-femoral bypass; Drug: Therapy: aspirin and clopidogrel; Procedure: Recanalization and stenting of aorta-iliac segment

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • Novosibirsk Research Institute of Circulation Pathology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; 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).	Procedure: Aorta-femoral bypass; Access to the femoral artery is performed through a lateral incision from the inguinal ligament. Operations technique on the abdominal aorta. Aorta-femoral bypass. Proximal anastomosis between the prosthesis and aorta is applied in the sort of "end-to-side" in the reconstruction by shunting. After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. In a case of preserved antegrade blood flow the femoral artery anastomosis applied in the sort of "end-to-side". If antegrade flow is absent, anastomosis is formed in the sort of "end to end".; Drug: Therapy: aspirin and clopidogrel; prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).
Active Comparator: Group 2; 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).	Drug: Therapy: aspirin and clopidogrel; prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).; Procedure: Recanalization and stenting of aorta-iliac segment; Standard endovascular access is performed under local anesthesia and affected arterial segment is visualized. Stenosis or artery occlusion is passed with hydrophilic guide. In case of occlusion transluminal or subintimal (often "mixed") artery recanalization is performed. To maximize the preservation of the affected artery initial patency, occlusion recanalization is performed by ante-and retrograde accesses. Then stenosis or occlusion predilation is performed with balloon catheter (balloon catheter diameter is smaller than the affected artery diameter for 1-2 mm). After control angiography stent is installed in the aorta-iliac area throughout the lesion (lesion diameter corresponds to the stenotic arteries diameter).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Successful implantation of all devices without the need for conversion and with residual stenosis less than 30%	1 day
30-day complication rate	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 days
30-day primary patency rates	during the whole 30 days from the date of intervention. confirmation of patency of the arterial ultrasound of the operated segment.	30 days
30-day secondary patency rates	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	30-day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Investigators: Principal Investigator: Andrey Karpenko, MD, PhD, Novosibirsk Research Institute of Circulation Pathology

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2015
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): November 2, 2020

Study Registration Dates

• First Submitted: July 30, 2014
• First Submitted That Met QC Criteria: August 1, 2014
• First Posted (Estimated): August 5, 2014

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 12, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrin Modulating Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Neurotransmitter Agents; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel; Aspirin
• Other Study ID Numbers: TASC C,D