|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|
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
|Anticipated End Date:||2014|
|Compensation for Participating:||None|