Study of the AFB and Stenting of the Iliac Arteries

NCT ID: NCT02209350

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-02
• Study Completion Date: 2020-11-02

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Aorta-femoral bypass

Intervention Type: PROCEDURE

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".

Therapy: aspirin and clopidogrel

Intervention Type: DRUG

prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).

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).

Group Type: ACTIVE_COMPARATOR

Recanalization and stenting of aorta-iliac segment

Intervention Type: PROCEDURE

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).

Therapy: aspirin and clopidogrel

Intervention Type: DRUG

prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).

Interventions

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".

Intervention Type: 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).

Intervention Type: PROCEDURE

Therapy: aspirin and clopidogrel

prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrey Karpenko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Novosibirsk Research Institute of Circulation Pathology

Locations

Novosibirsk Research Institute of Circulation Pathology

Novosibirsk, , Russia

Countries

Russia

Other Identifiers

TASC C,D

Identifier Type: -

Identifier Source: org_study_id