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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
202
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).
Novosibirsk Research Institute of Circulation Pathology
Novosibirsk, Russia
Technical success
Successful implantation of all devices without the need for conversion and with residual stenosis less than 30%
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 30-day
Major adverse cardiovascular event (MACE)
composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
Time frame: 36 months
Limb salvage
preservation of a functional foot, eliminating the necessity for major amputation
Time frame: 36 months
Amputation-free survival
freedom from major limb amputation or death by any cause
Time frame: 36 months
Primary patency rates
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).
no occlusion or significant flow-limiting stenosis in the treated segment
Time frame: 36 months
Secondary patency rates
no occlusion or flow-limiting stenosis following at least one re-intervention aimed at restoring patency, in addition to all instances of primary patency
Time frame: 36 months