Trials / Completed
CompletedNCT01602159
Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Johns Hopkins University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Open Bypass Surgery | Open Bypass Surgery with Autogenous vein or PTFE Graft |
| 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). |
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2014-06-01
- Completion
- 2014-06-01
- First posted
- 2012-05-18
- Last updated
- 2018-09-28
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01602159. Inclusion in this directory is not an endorsement.