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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Mahmoud B Malas, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01602159
First received: May 16, 2012
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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 Intervention
Superficial Femoral Artery Stenosis
Superficial Femoral Artery Occlusion
Claudication
Rest Pain
Procedure: Open Bypass Surgery
Procedure: Angioplasty and Stenting

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Clinical improvement [ Time Frame: 12 Month Post Operatively ] [ Designated as safety issue: No ]
    Clinical Improvement is measured as at least 1 Rutherford category

  • Patency rate [ Time Frame: 12 Month Post Operatively ] [ Designated as safety issue: No ]
    Primary, primary assisted and secondary at 6, 12 month

  • Cost effectiveness [ Time Frame: 12 Month Post Operatively ] [ Designated as safety issue: No ]
    Cost Effectiveness factoring procedure and hospital admission costs


Secondary Outcome Measures:
  • Quality of Life improvement [ Time Frame: 12 Month Post Operatively ] [ Designated as safety issue: No ]
    Improvement of quality of life measured using VQL

  • Re-intervention rate [ Time Frame: 12 Month Post Operatively ] [ Designated as safety issue: No ]
  • Technical success of both treatment modalities [ Time Frame: 12 Month Post Operatively ] [ Designated as safety issue: No ]
  • 30-day operative mortality [ Time Frame: 12 Month Post Operatively ] [ Designated as safety issue: No ]
  • Time to return to work and regular activities [ Time Frame: 12 Month Post Operatively ] [ Designated as safety issue: No ]
  • Morbidity associated with both treatment modalities [ Time Frame: 12 Month Post Operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: July 2009
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602159

Contacts
Contact: Mahmoud B Malas, M.D., MHS 410-550-4335 bmalas1@jhmi.edu
Contact: Umair M Qazi, M.D., MPH 410-550-1355 uqazi1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Sub-Investigator: Umair M Qazi, M.D., MPH         
Sub-Investigator: Thomas Reifsnyder, M.D         
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Sub-Investigator: Bruce Perler, M.D         
Sub-Investigator: Elizabeth Ratchford, M.D         
Sub-Investigator: James Black, M.D         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Mahmoud B Malas, M.D., MHS Johns Hopkins University
  More Information

Additional Information:
No publications provided

Responsible Party: Mahmoud B Malas, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01602159     History of Changes
Other Study ID Numbers: ROBUST
Study First Received: May 16, 2012
Last Updated: May 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Claudication
SFA
Open Bypass
Angioplasty
Stenting

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014