Clinical trial NCT02209350: Study of the AFB and Stenting of the Iliac Arteries
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Aorta-iliac Segment Lesion (C,D Type by TASC II)
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2014-08-05
Enrollment: 202
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Technical success
timeFrame: 1 day
measure: 30-day complication rate
timeFrame: 30 days
measure: 30-day primary patency rates
timeFrame: 30 days
measure: 30-day secondary patency rates
timeFrame: 30-day
Secondary outcomes:
measure: Major adverse cardiovascular event (MACE)
timeFrame: 36 months
measure: Limb salvage
timeFrame: 36 months
measure: Amputation-free survival
timeFrame: 36 months
measure: Primary patency rates
timeFrame: 36 months
measure: Secondary patency rates
timeFrame: 36 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Research Institute of Circulation Pathology
Study officials:
affiliation: Novosibirsk Research Institute of Circulation Pathology
name: Andrey Karpenko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: