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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01602159
Recruitment Status : Completed
First Posted : May 18, 2012
Last Update Posted : September 28, 2018
Information provided by (Responsible Party):
Johns Hopkins University

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : July 2009
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

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 Name: Life Stent flexStar Stent System by Bard Inc. Tempe AZ

Primary Outcome Measures :
  1. Clinical improvement [ Time Frame: 12 Month Post Operatively ]
    Clinical Improvement is measured as at least 1 Rutherford category

  2. Patency rate [ Time Frame: 12 Month Post Operatively ]
    Primary, primary assisted and secondary at 6, 12 month

  3. Cost effectiveness [ Time Frame: 12 Month Post Operatively ]
    Cost Effectiveness factoring procedure and hospital admission costs

Secondary Outcome Measures :
  1. Quality of Life improvement [ Time Frame: 12 Month Post Operatively ]
    Improvement of quality of life measured using VQL

  2. Re-intervention rate [ Time Frame: 12 Month Post Operatively ]
  3. Technical success of both treatment modalities [ Time Frame: 12 Month Post Operatively ]
  4. 30-day operative mortality [ Time Frame: 12 Month Post Operatively ]
  5. Time to return to work and regular activities [ Time Frame: 12 Month Post Operatively ]
  6. Morbidity associated with both treatment modalities [ Time Frame: 12 Month Post Operatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01602159

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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Mahmoud B Malas, M.D., MHS Johns Hopkins University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Johns Hopkins University Identifier: NCT01602159    
Other Study ID Numbers: NA_00027939
First Posted: May 18, 2012    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Keywords provided by Johns Hopkins University:
Open Bypass
Additional relevant MeSH terms:
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Intermittent Claudication
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases