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

• ClinicalTrials.gov Identifier: NCT01602159
• Recruitment Status: Completed
• First Posted: May 18, 2012
• Last Update Posted: September 28, 2018
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Tracking Information

• First Submitted Date: May 16, 2012
• First Posted Date: May 18, 2012
• Last Update Posted Date: September 28, 2018
• Actual Study Start Date: July 2009
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 17, 2012)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 17, 2012)

• Quality of Life improvement [ Time Frame: 12 Month Post Operatively ]
  Improvement of quality of life measured using VQL
• Re-intervention rate [ Time Frame: 12 Month Post Operatively ]
• Technical success of both treatment modalities [ Time Frame: 12 Month Post Operatively ]
• 30-day operative mortality [ Time Frame: 12 Month Post Operatively ]
• Time to return to work and regular activities [ Time Frame: 12 Month Post Operatively ]
• Morbidity associated with both treatment modalities [ Time Frame: 12 Month Post Operatively ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)
• Official Title: Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

• Procedure: Open Bypass Surgery
  Open Bypass Surgery with Autogenous vein or PTFE Graft
• 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

Study Arms

• Active Comparator: Open Bypass Surgery
  Open Bypass Surgery
  Intervention: Procedure: Open Bypass Surgery
• Active Comparator: Angioplasty and Stenting
  Intervention: Procedure: Angioplasty and Stenting

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 26, 2018): 29
• Original Estimated Enrollment (submitted: May 17, 2012): 70
• Actual Study Completion Date: June 2014
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01602159
• Other Study ID Numbers: NA_00027939
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Johns Hopkins University
• Study Sponsor: Johns Hopkins University
• Collaborators: Not Provided

Investigators

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

• PRS Account: Johns Hopkins University
• Verification Date: September 2018