Comparison of Bypass Surgery and Endovascular Treatment for Long Blockages in the Superficial Femoral Artery Causing Leg Pain During Walking

What this Trial Is About

Researchers are evaluating treatment options for patients with lower limb peripheral arterial disease who have long lesions 15-25 cm in the superficial femoral artery causing intermittent claudication. This condition affects many active patients over age 60. The study aims to compare the effectiveness of femoro-popliteal bypass surgery versus endovascular procedures, as current evidence is limited and no dedicated clinical trial has directly compared these approaches. Participants will be randomly assigned to one of two groups. One group will receive a femoro-popliteal bypass under general or local anesthesia using the best available vascular substitute, such as an inverted saphenous vein or prosthesis. The other group will undergo an endovascular procedure involving balloon angioplasty, often followed by stent placement or drug-coated balloon angioplasty, performed under general anesthesia, local anesthesia, or sedation. During the study, participants will be monitored for up to two years. Researchers will assess the primary patency rate of the treated artery at 2 years, along with secondary patency rates at 1 and 2 years. Clinical improvements will be evaluated at several time points using the Rutherford classification and walking distance measures. Additional assessments include systolic pressure index, quality of life questionnaires, treatment burden, and adverse events like hematoma or infection. Participants will have regular follow-ups throughout the study period to track these outcomes.

Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant