Study of the AFB and Stenting of the Iliac Arteries (NCT02209350) | Clinical Trial Compass
CompletedPhase 1
Study of the AFB and Stenting of the Iliac Arteries
Russia202 participantsStarted 2015-08-02
Plain-language 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).
Who can participate
Age range45 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Technical success
Timeframe: 1 day
2
30-day complication rate
Timeframe: 30 days
3
30-day primary patency rates
Timeframe: 30 days
4
30-day secondary patency rates
Timeframe: 30-day
Trial details
NCT IDNCT02209350
SponsorMeshalkin Research Institute of Pathology of Circulation