Choosing an Access for Endovascular Treatment of Femoral-popliteal Segment Occlusions

The purpose of the study: to compare the complication rate of the shoulder and retrograde femoral access in elderly patients with occlusive lesions of the femoral-popliteal segment of the lower extremity arteries.

Scientific hypotheses:

1. The shoulder access has a lower number of complications compared to the femoral access
2. The shoulder access has a lower number of complications requiring surgical intervention compared to the femoral access
3. The shoulder access has a comparable % of success of the main intervention with the femoral access Inclusion criteria: arterial diameter at the access site of at least 3 mm, indications for endovascular intervention on the lower extremity arteries, age of 60 years or more, and patient consent to participate in the study.

Exclusion criteria: inability to perform an access due to stenotic lesions of the above-mentioned arteries (common femoral, iliac, axillary, subclavian arteries, brachiocephalic trunk); height more than 180 cm; presence of concomitant pathology limiting the survival of patients; pathology of the blood coagulation system (hemophilia, thrombocytopathies, etc.), previously performed catheterization through the access artery.

The required sample size was calculated using the M. Blanda method for a study with increased accuracy. The required level of significance (α) was 0.05, and the study's power was 95%. The estimated complication rates in the Femoral and Brachial groups were assumed to be 2% and 9%, respectively. Under these conditions, the estimated sample size was 269 patients. The planned loss rate during the study was 5%. Therefore, the minimum sample size was 283 patients.