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

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT01602159

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

14.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Superficial Femoral Artery Stenosis Superficial Femoral Artery Occlusion Claudication Rest Pain	Procedure: Open Bypass Surgery Procedure: Angioplasty and Stenting	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Life Stent flexStar Stent System by Bard Inc. Tempe AZ

Arm

Intervention/Treatment

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 Names:

Life Stent flexStar Stent System by Bard Inc. Tempe AZ

Outcome Measures

Primary Outcome Measures

Clinical improvement [12 Month Post Operatively]
Clinical Improvement is measured as at least 1 Rutherford category
Patency rate [12 Month Post Operatively]
Primary, primary assisted and secondary at 6, 12 month
Cost effectiveness [12 Month Post Operatively]
Cost Effectiveness factoring procedure and hospital admission costs

Secondary Outcome Measures

Quality of Life improvement [12 Month Post Operatively]
Improvement of quality of life measured using VQL
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).