Endovascular revascularization and open bypass grafting above the knee show comparable results in primary 2-year patency (about 65%) in medium-length lesions - TASC II, C (Pereira et al, 2006). At the same time, a recent study, where the authors studied the effectiveness of stenting of long lesions (200 mm or more) of the chronic occlusions of the femoropopliteal segments (TASC II, D), showed unsatisfactory results (primary patency 45%) of the stented segment within 2 years (Lin et al, 2015). One of the possible solutions to the problem of breakage of stents in the femoral-popliteal position is a modified method of their manufacture by braiding from nitinol wire. Some studies with intervowen nitinol stents did show their resistance to breakage in this position. Moreover, the primary patency was \> 70%. (Werner et al, 2014). These data suggest a better primary patency rate within 2 years with a longer lesion length (\>200 mm). This is a prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal segment above the knee, TASC II type D - femoropopliteal proximal shunting and recanalization with angioplasty and stenting using biomimetic interwoven nitinol stent in patients with symptomatic peripheral arterial disease at 24 months. Secondary objectives are to identify predictors of restenosis and occlusions of the operating segment and compare the quality of life of patients after the procedure. It is planned to recruit 110 patients (55 patients in each group). Observation period 2 years. Primary endpoint: -The effectiveness of the method of surgical treatment after 24 months (primary patency, primary-assisted patency, secondary patency). Secondary endpoints: * Clinical efficacy of the method of surgical treatment after 24 months (MALE); * Safety of the method of surgical treatment in the early postoperative period (hematoma of the surgical access area, peripheral neuropathy, purulent-infectious complications of the surgical access area) and after 24 months (MACE); * Assessment of the quality of life in patients after surgical treatment at 6, 12, and 24 months (SF-36 questionnaire); * Evaluation of prognostic factors for adverse outcomes after surgical treatment.
Age range
18 Years
Sex
ALL
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primary patency
Timeframe: 24 months
primary assisted patency
Timeframe: 24 months
secondary patency
Timeframe: 24 months