Claudication Clinical Trial
Official title:
Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)
This is a prospective randomized controlled trial to compare clinical improvement, cost
effectiveness and patency rates between new and improved Nitinol stents and open bypass
surgery in the superficial femoral artery disease.
Secondary outcomes also include comparing quality of life, re-intervention rate, mortality,
morbidity and time to return to work or regular activities.
Patients with superficial femoral artery lesions will be considered. Patients with TASC II A
lesions will not be randomized but treated with PTA/stenting as standard of care. Patients
with TASC II B and C lesions will be prospectively randomized into either receiving open
bypass or stenting.
Patients with TASC D lesions will be treated with open bypass surgery after angiography.
The investigators will collect pre-procedure, peri-procedural and clinical follow-up data on
all enrolled the patients.
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