ROBUST.

Trial name or title	Revascularization with Open Bypass versUs angioplasty and STenting of the lower extremity trial (ROBUST)
Methods	Allocation: randomised Intervention model: parallel assignment Masking: open label Primary purpose: treatment
Participants	Symptomatic individuals with IC or CLI; individuals with TASC II B and C lesions of the SFA
Interventions	Open bypass surgery with autogenous vein or PTFE graft versus angioplasty and stenting of the SFA with nitinol stent
Outcomes	Primary outcome measures: Clinical improvement Patency rate Cost effectiveness Secondary outcome measures: QoL improvement Reintervention rate 30‐day operative mortality Time to return to work and regular activities Morbidity associated with both treatment modalities
Starting date	July 2009
Contact information	Mahmoud B Malas, M.D., MHS: bmalas1@jhmi.edu; Umair M Qazi, M.D., MPH: uqazi1@jhmi.edu
Notes	NCT01602159 Sponsors and Collaborators: Johns Hopkins University