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Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST) — ROBUST  

Claudication Clinical Trial

Official title:
Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01602159
Study type Interventional
Source Johns Hopkins University
Contact
Status Completed
Phase N/A
Start date July 2009
Completion date June 2014
View Details
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