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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

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:

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.

Sites / Locations

Johns Hopkins Hospital
Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

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

NCT ID

NCT01602159

First Posted

May 16, 2012

Last Updated

September 26, 2018

Sponsor

Johns Hopkins University

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

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

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

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