The Pilot Clinical Trial Comparing the Efficacy of Single-stage Multilevel Revascularization of the Iliac-femoral-popliteal Segment Using the FULL METALL JACKET Technology in Comparison With the Hybrid Revascularization Procedure

Mortality from cardiovascular disease occupies a leading position worldwide. Patients with atherosclerotic lesions of the peripheral arteries account for 20% of the total number of patients with cardiovascular diseases. Special attention should be paid to patients with multilevel lesions artery since the maximum reduction in blood flow leads to the development of critical limb ischemia (CLI) and a high risk of limb loss. Almost 25% of patients with CLI require multistory revascularization of the arteries of the lower extremities. In this group of patients, proximal revascularization of the only iliac segment is usually the initial approach, but in some cases leads to disappointing relief of symptoms due to concomitant severe lesions of the infra-anginal arteries. Whereas the combined implementation of femoral-popliteal bypass surgery or endovascular revascularization of SFA can increase the likelihood of ulcer healing and avoid multi-stage surgical interventions. In turn, an adequate inflow to the revascularized segment is necessary for its long-term functioning.

Femoral-popliteal bypass surgery is still the procedure of choice for long occlusions of the superficial femoral artery TASC C, D. The "total" endovascular correction (full metal jacket) may become an alternative to hybrid technology since allows for less traumatic and fully revascularization of the wall occlusal lesions of SFA. The salvation of the limb and the achievement of compensation for the clinic of chronic lower limb ischemia in patients with multi-vessel atherosclerotic lesions of the arteries of the lower extremities is possible using both hybrid procedures and endovascular reconstruction. The main goal of stenting the iliac arteries during hybrid procedures is not only to restore blood flow in the common and deep femoral arteries but also to support the long-term functioning of the femoral-popliteal shunt or stent in SFA.

Similar analogues of the comparative study of the two methods of revascularization in the world literature the investigators have not seen.

In the first group, stenting of the iliac artery under x-ray control with the bypass of the femoral-popliteal segment above the gap of the knee joint is performed. The first stage is performed femoral-popliteal bypass surgery above the fissure of the knee joint according to conventional technology. Conduit is at the discretion of the operating surgeon. Intraoperatively bolus is administered heparin 5000 IU. The second step is the puncture of the selected CFA with a retrograde installation of the introducer sheath. The iliac segment is recanalized with angioplasty and stent implantation in the affected area. In the postoperative period, clexane is administered at a prophylactic dosage of 3 days and cardiomagnyl at a dosage of 75 mg per day. Next, the patient takes dual antiplatelet therapy cardiomagnyl 75 mg + clopidogrel 75 mg for 6 months.

In the second group, stenting of the iliac artery and recanalization SFA with angioplasty and stenting under X-ray control is performed. The first step is the puncture contralateral CFA with a retrograde installation of the introducer. Intraoperatively bolus is administered heparin 5000 IU. A conductor is placed in the contralateral iliac artery along the conductor. A stent is implanted in the iliac artery lesion. The second stage is the recanalization of the femoral-popliteal segment with angioplasty and stent implantation in the affected area. In the postoperative period, a loading dose of clopidogrel 300 mg + cardiomagnyl 75 mg is taken. Next, the patient takes dual antiplatelet therapy cardiomagnyl 75 mg + clopidogrel 75 mg for 6 months.