search
Back to results

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

Primary Purpose

Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion, Claudication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Open Bypass Surgery
Angioplasty and Stenting
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Superficial Femoral Artery Stenosis focused on measuring Claudication, SFA, Open Bypass, Angioplasty, Stenting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Hospital
  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Open Bypass Surgery

Angioplasty and Stenting

Arm Description

Open Bypass Surgery

Outcomes

Primary Outcome Measures

Clinical improvement
Clinical Improvement is measured as at least 1 Rutherford category
Patency rate
Primary, primary assisted and secondary at 6, 12 month
Cost effectiveness
Cost Effectiveness factoring procedure and hospital admission costs

Secondary Outcome Measures

Quality of Life improvement
Improvement of quality of life measured using VQL
Re-intervention rate
Technical success of both treatment modalities
30-day operative mortality
Time to return to work and regular activities
Morbidity associated with both treatment modalities

Full Information

First Posted
May 16, 2012
Last Updated
September 26, 2018
Sponsor
Johns Hopkins University
search

1. Study Identification

Unique Protocol Identification Number
NCT01602159
Brief Title
Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)
Acronym
ROBUST
Official Title
Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 2009 (Actual)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion, Claudication, Rest Pain
Keywords
Claudication, SFA, Open Bypass, Angioplasty, Stenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Bypass Surgery
Arm Type
Active Comparator
Arm Description
Open Bypass Surgery
Arm Title
Angioplasty and Stenting
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Open Bypass Surgery
Intervention Description
Open Bypass Surgery with Autogenous vein or PTFE Graft
Intervention Type
Procedure
Intervention Name(s)
Angioplasty and Stenting
Other Intervention Name(s)
Life Stent flexStar Stent System by Bard Inc. Tempe AZ
Intervention Description
Angioplasty and Stenting of the superficial Femoral artery with Nitinol stent (Life Stent flexStar Stent System by Bard Inc. Tempe AZ).
Primary Outcome Measure Information:
Title
Clinical improvement
Description
Clinical Improvement is measured as at least 1 Rutherford category
Time Frame
12 Month Post Operatively
Title
Patency rate
Description
Primary, primary assisted and secondary at 6, 12 month
Time Frame
12 Month Post Operatively
Title
Cost effectiveness
Description
Cost Effectiveness factoring procedure and hospital admission costs
Time Frame
12 Month Post Operatively
Secondary Outcome Measure Information:
Title
Quality of Life improvement
Description
Improvement of quality of life measured using VQL
Time Frame
12 Month Post Operatively
Title
Re-intervention rate
Time Frame
12 Month Post Operatively
Title
Technical success of both treatment modalities
Time Frame
12 Month Post Operatively
Title
30-day operative mortality
Time Frame
12 Month Post Operatively
Title
Time to return to work and regular activities
Time Frame
12 Month Post Operatively
Title
Morbidity associated with both treatment modalities
Time Frame
12 Month Post Operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical Inclusion: 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. Anatomical Inclusion: 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 Exclusion Criteria: Clinical exclusion: 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. Prior stenting or bypass of SFA (prior PTA is not an exclusion criteria) 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). Anatomic Exclusion: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud B Malas, M.D., MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25353642
Citation
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.
Results Reference
derived
Links:
URL
http://www.hopkinsmedicine.org/heart_vascular_institute/clinical_trials/vascular/robust.html
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs