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

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.

Study Overview

• Status: Completed
• Conditions: Superficial Femoral Artery Occlusion; Claudication; Superficial Femoral Artery Stenosis; Rest Pain
• Intervention / Treatment: Procedure: Open Bypass Surgery; Procedure: Angioplasty and Stenting

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Hospital
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
5. Prior stenting or bypass of SFA (prior PTA is not an exclusion criteria)
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Mahmoud B Malas, M.D., MHS, Johns Hopkins University

Publications and helpful links

General Publications

• Malas MB, Qazi U, Glebova N, Arhuidese I, Reifsnyder T, Black J, Perler BA, Freischlag JA. Design of the Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST): a randomized clinical trial. JAMA Surg. 2014 Dec;149(12):1289-95. doi: 10.1001/jamasurg.2014.369.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2009
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: May 16, 2012
• First Submitted That Met QC Criteria: May 17, 2012
• First Posted (ESTIMATE): May 18, 2012

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2018
• Last Update Submitted That Met QC Criteria: September 26, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Claudication; Angioplasty; SFA; Stenting; Open Bypass
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intermittent Claudication
• Other Study ID Numbers: NA_00027939