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

NCT01602159 | Completed DMC

• 1 other identifier: NA_00027939
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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.

Conditions

Superficial Femoral Artery Stenosis; Superficial Femoral Artery Occlusion; Claudication; Rest Pain

Keywords

Claudication; SFA; Open Bypass; Angioplasty; Stenting

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Quality of Life improvement

  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

Study Arms (2)

Open Bypass Surgery

ACTIVE COMPARATOR

Open Bypass Surgery

Procedure: Open Bypass Surgery

Angioplasty and Stenting

ACTIVE COMPARATOR

Procedure: Angioplasty and Stenting

Interventions

Open Bypass Surgery PROCEDURE

Open Bypass Surgery with Autogenous vein or PTFE Graft

Open Bypass Surgery

Angioplasty and Stenting PROCEDURE

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

Also known as: Life Stent flexStar Stent System by Bard Inc. Tempe AZ

Angioplasty and Stenting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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).
• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• 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.

  PMID: 25353642 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Intermittent Claudication

Interventions

Angioplasty; Stents

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Prostheses and Implants; Equipment and Supplies

Study Officials

• Mahmoud B Malas, M.D., MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2012
• First Posted: May 18, 2012
• Study Start: July 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 28, 2018

Record last verified: 2018-09

Locations

US (2)