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Summary of Trial: 
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.
Principal Investigator:Mahmoud B Malas, M.D., MHS, FACS
Study Coordinator:

Umair Qazi, M.D., MPH

Study Long Title: 

Revascularization with Open Bypass vs. Angioplasty and STenting of the Lower Extremity Trial.

Study Short Title: ROBUST
JHU IRB Number:


Funding Source:No Outside Funding
Important Inclusion Criteria:

Patient has failed maximized medical treatment and exercise program.

Patient has a resting ABI < 0.9 or an abnormal exercise ABI if resting ABI is normal. Patient with non-compressible arteries (ABI > 1.2) must have a TBI < 0.8.

Patient has a de novo or restenotic lesion(s) with > 50% stenosis

Important Exclusion Criteria:

Prior stenting or bypass of SFA (prior PTA is not an exclusion criteria)

Unstable angina, recent MI within a month.

Malignancy or other condition limiting life expectancy to <5 years.

Renal insufficiency (serum Cr>2.0

Clinical Trial Site: Johns Hopkins Bayview Medical Center
4940 Eastern Ave
Baltimore MD 21224
Start Date:2009
Anticipated End Date:2014
Compensation for Participating: None