Study of the AFB and Stenting of the Iliac Arteries

NCT02209350 | Completed Phase 1 DMC

• 1 other identifier: TASC C,D
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Major adverse cardiovascular event (MACE)

  36 months

• Limb salvage

  36 months

• Amputation-free survival

  36 months

• Primary patency rates

  36 months

• Secondary patency rates

  36 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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; Drug: Therapy: aspirin and clopidogrel

Group 2

ACTIVE COMPARATOR

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).

Procedure: Recanalization and stenting of aorta-iliac segment; Drug: Therapy: aspirin and clopidogrel

Interventions

Aorta-femoral bypass 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".

Group 1

Recanalization and stenting of aorta-iliac segment 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).

Group 2

Therapy: aspirin and clopidogrel DRUG

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

Group 1; Group 2

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

Novosibirsk Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Location

MeSH Terms

Interventions

Clopidogrel

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Andrey Karpenko, MD, PhD

  Novosibirsk Research Institute of Circulation Pathology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: August 5, 2014
• Study Start: August 2, 2015
• Primary Completion: November 1, 2020
• Study Completion: November 2, 2020
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

RU (1)