Novosibirsk Research Institute of Circulation Pathology
Novosibirsk, 630055, Russia
NCT Number: NCT02209350
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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Notify Me45 year–75 year
All sexes
Interventional
Phase 1
Novosibirsk, 630055, Russia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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".
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).
prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).
Time frame: 1 day
Successful implantation of all devices without the need for conversion and with residual stenosis less than 30%
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
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.
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
Time frame: 36 months
composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
Time frame: 36 months
preservation of a functional foot, eliminating the necessity for major amputation
Time frame: 36 months
freedom from major limb amputation or death by any cause
Time frame: 36 months
no occlusion or significant flow-limiting stenosis in the treated segment
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
Meshalkin Research Institute of Pathology of Circulation
Network
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
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