Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST) (ROBUST)
Recruitment status was: Recruiting
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.
|Superficial Femoral Artery Stenosis Superficial Femoral Artery Occlusion Claudication Rest Pain||Procedure: Open Bypass Surgery Procedure: Angioplasty and Stenting|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)|
- Clinical improvement [ Time Frame: 12 Month Post Operatively ]Clinical Improvement is measured as at least 1 Rutherford category
- Patency rate [ Time Frame: 12 Month Post Operatively ]Primary, primary assisted and secondary at 6, 12 month
- Cost effectiveness [ Time Frame: 12 Month Post Operatively ]Cost Effectiveness factoring procedure and hospital admission costs
- Quality of Life improvement [ Time Frame: 12 Month Post Operatively ]Improvement of quality of life measured using VQL
- Re-intervention rate [ Time Frame: 12 Month Post Operatively ]
- Technical success of both treatment modalities [ Time Frame: 12 Month Post Operatively ]
- 30-day operative mortality [ Time Frame: 12 Month Post Operatively ]
- Time to return to work and regular activities [ Time Frame: 12 Month Post Operatively ]
- Morbidity associated with both treatment modalities [ Time Frame: 12 Month Post Operatively ]
|Study Start Date:||July 2009|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Open Bypass Surgery
Open Bypass Surgery
Procedure: Open Bypass Surgery
Open Bypass Surgery with Autogenous vein or PTFE Graft
|Active Comparator: Angioplasty and Stenting||
Procedure: Angioplasty and Stenting
Angioplasty and Stenting of the superficial Femoral artery with Nitinol stent (Life Stent flexStar Stent System by Bard Inc. Tempe AZ).
Other Name: Life Stent flexStar Stent System by Bard Inc. Tempe AZ
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602159
|Contact: Mahmoud B Malas, M.D., MHSemail@example.com|
|Contact: Umair M Qazi, M.D., MPHfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Sub-Investigator: Bruce Perler, M.D|
|Sub-Investigator: Elizabeth Ratchford, M.D|
|Sub-Investigator: James Black, M.D|
|Johns Hopkins Bayview Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Sub-Investigator: Umair M Qazi, M.D., MPH|
|Sub-Investigator: Thomas Reifsnyder, M.D|
|Sub-Investigator: Maya Salameh, M.D|
|Sub-Investigator: Rajiv Thakkar, M.D|
|Principal Investigator:||Mahmoud B Malas, M.D., MHS||Johns Hopkins University|