Superficial Femoral Artery StenosisROBUSTNCT01602159
Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)
A study testing Open Bypass Surgery and Angioplasty and Stenting in people with Superficial Femoral Artery Stenosis and Superficial Femoral Artery Occlusion, run by Johns Hopkins University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion, Claudication
- What is being tested?
- Open Bypass Surgery and Angioplasty and Stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2009to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
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.
Read more
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.
- Conditions
- Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion, Claudication, Rest Pain
- Being tested
- Open Bypass Surgery, Angioplasty and Stenting
- Keywords
- Claudication, SFA, Open Bypass, Angioplasty, Stenting
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Bypass SurgeryProcedure or surgery
Open Bypass Surgery with Autogenous vein or PTFE Graft
Angioplasty and StentingProcedure or surgery
Also called Life Stent flexStar Stent System by Bard Inc. Tempe AZ
Angioplasty and Stenting of the superficial Femoral artery with Nitinol stent (Life Stent flexStar Stent System by Bard Inc. Tempe AZ).
| Study group | Role | What they receive |
|---|---|---|
| Open Bypass Surgery | Active comparator | Open Bypass Surgery Receives: Procedure: Open Bypass Surgery |
| Angioplasty and Stenting | Active comparator | Not described Receives: Procedure: Angioplasty and Stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
Clinical Improvement is measured as at least 1 Rutherford category
Measured: 12 Month Post Operatively
Patency rate
Primary, primary assisted and secondary at 6, 12 month
Measured: 12 Month Post Operatively
Cost effectiveness
Cost Effectiveness factoring procedure and hospital admission costs
Measured: 12 Month Post Operatively
Secondary outcomes (6)
Quality of Life improvement
Improvement of quality of life measured using VQL
Measured: 12 Month Post Operatively
Re-intervention rate
Measured: 12 Month Post Operatively
Technical success of both treatment modalities
Measured: 12 Month Post Operatively
30-day operative mortality
Measured: 12 Month Post Operatively
Time to return to work and regular activities
Measured: 12 Month Post Operatively
Morbidity associated with both treatment modalities
Measured: 12 Month Post Operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startJul 2009
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Superficial Femoral Artery StenosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud B Malas, M.D., MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602159
- Sponsor's protocol ID
- NA_00027939
- Acronym
- ROBUST
- Status last verified
- Sep 2018
- First submitted
- 16 May 2012
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 25353642
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)
- ClinicalTrials.gov ID
- NCT01602159
- Acronym / sponsor ID
- ROBUST / NA_00027939
- Conditions
- Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion, Claudication, Rest Pain
- Keywords
- Claudication, SFA, Open Bypass, Angioplasty, Stenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jul 2009 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Bypass Surgery | Active comparator | Procedure: Open Bypass SurgeryOpen Bypass Surgery |
| Angioplasty and Stenting | Active comparator | Procedure: Angioplasty and Stenting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Bypass SurgeryOpen Bypass Surgery with Autogenous vein or PTFE Graft | Procedure or surgery | Open Bypass Surgery |
| Angioplasty and StentingAlso: Life Stent flexStar Stent System by Bard Inc. Tempe AZAngioplasty and Stenting of the superficial Femoral artery with Nitinol stent (Life Stent flexStar Stent System by Bard Inc. Tempe AZ). | Procedure or surgery | Angioplasty and Stenting |
Primary outcome
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
6 secondary outcomes
Quality of Life improvement
Time frame: 12 Month Post Operatively
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Derived from this study: PubMed 25353642Malas 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud B Malas, M.D., MHS principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Bypass Surgery and Angioplasty and Stenting in people with Superficial Femoral Artery Stenosis and Superficial Femoral Artery Occlusion, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (time frame: 12 Month Post Operatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01602159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.