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Completed

NCT Number: NCT02209350

Study of the AFB and Stenting of the Iliac Arteries

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).

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novosibirsk Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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".

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).

Therapy: aspirin and clopidogrel

Drug

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

Primary outcomes

  1. Technical success

    Time frame: 1 day

    Successful implantation of all devices without the need for conversion and with residual stenosis less than 30%

  2. 30-day complication rate

    Time frame: 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

  3. 30-day primary patency rates

    Time frame: 30 days

    during the whole 30 days from the date of intervention. confirmation of patency of the arterial ultrasound of the operated segment.

  4. 30-day secondary patency rates

    Time frame: 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

Secondary outcomes

  1. Major adverse cardiovascular event (MACE)

    Time frame: 36 months

    composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

  2. Limb salvage

    Time frame: 36 months

    preservation of a functional foot, eliminating the necessity for major amputation

  3. Amputation-free survival

    Time frame: 36 months

    freedom from major limb amputation or death by any cause

  4. Primary patency rates

    Time frame: 36 months

    no occlusion or significant flow-limiting stenosis in the treated segment

  5. Secondary patency rates

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2014
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.