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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2014-06-30

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.

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Detailed Description

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Conditions

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Superficial Femoral Artery Stenosis Superficial Femoral Artery Occlusion Claudication Rest Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Bypass Surgery

Group Type ACTIVE_COMPARATOR

Open Bypass Surgery

Intervention Type PROCEDURE

Open Bypass Surgery with Autogenous vein or PTFE Graft

Angioplasty and Stenting

Group Type ACTIVE_COMPARATOR

Angioplasty and Stenting

Intervention Type PROCEDURE

Angioplasty and Stenting of the superficial Femoral artery with Nitinol stent (Life Stent flexStar Stent System by Bard Inc. Tempe AZ).

Interventions

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Open Bypass Surgery

Open Bypass Surgery with Autogenous vein or PTFE Graft

Intervention Type 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).

Intervention Type PROCEDURE

Other Intervention Names

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Life Stent flexStar Stent System by Bard Inc. Tempe AZ

Eligibility Criteria

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Inclusion Criteria

Clinical Inclusion:

1. Must be at least 18 years of age.
2. 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.
3. Symptomatic patient as evidence by IC or CLI.
4. Patient has failed maximized medical treatment and exercise program.
5. 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.
6. Patient has a de novo or restenotic lesion(s) with \> 50% stenosis documented angiographically.
7. Patient agrees to return for all required clinical contacts following study enrollment.
8. Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure.

Anatomical Inclusion:

1. Patient with any SFA lesion
2. At least one tibial vessel runoff with \< 50% stenosis
3. Lesion starts start at least 1 cm distal to the deep femoral artery
4. Lesion end at least 3 cm above the knee joint
5. Target vessel reference diameter is \> 3 mm \& \< 6.5 mm

Exclusion Criteria

Clinical exclusion:

1. Known allergic reaction to anesthesia not able to overcome by medication.
2. Known allergic reaction to contrast not able to overcome by medication.
3. Known history of intolerance to study medicating including ASA, clopidogrel, or ticlopidine.
4. Bleeding disorder or refuses blood transfusion.
6. Unstable angina, recent MI within a month
7. Malignancy or other condition limiting life expectancy to \< 5 years.
8. Renal insufficiency (serum Cr \> 2.0)
9. Patient has any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe (e.g., morbid obesity).

Anatomic Exclusion:

1. Lesion \< 1 cm from origin of DFA
2. Lesion \< 3 cm from the knee joint
3. Chronic total occlusion of SFA \> 20cm.
4. Chronic total occlusion of CFA.
5. Proximal trifurcation occlusions.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No