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

Study Overview
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Brief Summary
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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.

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

Conditions
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Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion, Claudication, Rest Pain

Intervention / Treatment
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* Procedure: Open Bypass Surgery
* Procedure: Angioplasty and Stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical Inclusion: Must be at least 18 years of age. Patient has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB)/Medical Ethics Committee (MEC) of the respective clinical site. Symptomatic patient as evidence by IC or CLI. 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 documented angiographically. Patient agrees to return for all required clinical contacts following study enrollment. Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure. Anatomical Inclusion: Patient with any SFA lesion At least one tibial vessel runoff with < 50% stenosis Lesion starts start at least 1 cm distal to the deep femoral artery Lesion end at least 3 cm above the knee joint Target vessel reference diameter is > 3 mm & < 6.5 mm Exclusion Criteria: Clinical exclusion: Known allergic reaction to anesthesia not able to overcome by medication. Known allergic reaction to contrast not able to overcome by medication. Known history of intolerance to study medicating including ASA, clopidogrel, or ticlopidine. Bleeding disorder or refuses blood transfusion. 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) Patient has any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe (e.g., morbid obesity). Anatomic Exclusion: Lesion < 1 cm from origin of DFA Lesion < 3 cm from the knee joint Chronic total occlusion of SFA > 20cm. Chronic total occlusion of CFA. Proximal trifurcation occlusions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open Bypass Surgery<br>Open Bypass Surgery | Procedure: Open Bypass Surgery<br>* Open Bypass Surgery with Autogenous vein or PTFE Graft<br>|
| Active Comparator: Angioplasty and Stenting<br> | Procedure: Angioplasty and Stenting<br>* Angioplasty and Stenting of the superficial Femoral artery with Nitinol stent (Life Stent flexStar Stent System by Bard Inc. Tempe AZ).<br>* Other names: Life Stent flexStar Stent System by Bard Inc. Tempe AZ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement | Clinical Improvement is measured as at least 1 Rutherford category | 12 Month Post Operatively | 
| Patency rate | Primary, primary assisted and secondary at 6, 12 month | 12 Month Post Operatively | 
| Cost effectiveness | Cost Effectiveness factoring procedure and hospital admission costs | 12 Month Post Operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life improvement | Improvement of quality of life measured using VQL | 12 Month Post Operatively | 
| Re-intervention rate |  | 12 Month Post Operatively | 
| Technical success of both treatment modalities |  | 12 Month Post Operatively | 
| 30-day operative mortality |  | 12 Month Post Operatively | 
| Time to return to work and regular activities |  | 12 Month Post Operatively | 
| Morbidity associated with both treatment modalities |  | 12 Month Post Operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Claudication, SFA, Open Bypass, Angioplasty, Stenting