Comparison of the SUpera® PERipheral System in the Superficial Femoral Artery
NCT ID: NCT00933270
Last Updated: 2017-05-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
325 participants
INTERVENTIONAL
2009-07-31
2014-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main objective of this study is to demonstrate the safety and effectiveness of the IDev SUPERA® Nitinol Stent System in treating subjects with obstructive superficial femoral artery (SFA) disease. The primary endpoint will be the primary patency of the SFA evaluated at 12 months. The outcome will be compared to a performance goal based on clinical trials of percutaneous transvenous angioplasty (PTA) alone.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions
NCT03332264
The Study to Compare SMART Nitinol Stent and Balloon Angioplasty
NCT00309595
S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease
NCT00739102
Clinical Trial Investigating the Efficacy of the Supera Peripheral Stent System for the Treatment of the Common Femoral Artery
NCT02804113
A Study of the SMART Stent in the Treatment SFA Disease.
NCT00232869
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SUPERA® Nitinol Stent System
Implantation of SUPERA nitinol stent using the SUPERA® Nitinol Stent System
SUPERA® Nitinol Stent System
Percutaneous Angioplasty of the Superior Femoral Artery with placement of a SUPERA® Stent at time of PTA
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SUPERA® Nitinol Stent System
Percutaneous Angioplasty of the Superior Femoral Artery with placement of a SUPERA® Stent at time of PTA
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Women of child bearing potential must have a negative pregnancy test within 7 days prior to the index procedure.
3. Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ankle-brachial index (ABI) less than or equal to 0.9. TBI (toe-brachial index) is performed only unable to assess ABI. TBI must be less than or equal to 0.7.
4. A single superficial femoral artery lesion with greater than 60% stenosis or total occlusion.
5. Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) greater than or equal to 40 mm to less than or equal to 140 mm. Reference vessel diameter (RVD) greater than or equal to 4.0 mm and less than or equal to 6.0 mm by visual assessment.
6. All lesions are to be located with the distal point at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and proximal point at least 2 cm below the origin of the profunda artery.
7. Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (less than 50% stenosis) to the ankle or foot.
8. The target lesion(s) can be successfully crossed with a guide wire and dilated.
9. Poor aortoiliac or common femoral "inflow" (i.e., angiographically defined greater than 50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoropopliteal bypass graft must be successfully treated prior to treatment of the target lesion. This can be done just prior to treatment of the target lesion. Successful treatment is defined as less than 30% stenosis after either PTA or stenting of the inflow lesion. After treatment of the inflow lesion, the pressure gradient across the target lesion will be obtained and if the pressure gradient is greater than or equal to 20 mmHg, then the subject will be included in the study.
10. A subject with bilateral obstructive SFA disease is eligible for enrollment into the study. If a subject with bilateral disease is enrolled, the target limb will be selected at the Investigator's discretion, who may use the criteria of lesion length, percent stenosis, and/or calcification content. The contra-lateral procedure should not be done until at least 30 days after the index procedure (staged); however, if contralateral treatment is performed prior to treatment of the target lesion, the waiting period will be at least 14 days prior to the index procedure.
11. The subject is eligible for standard surgical repair, if necessary.
12. A subject who requires a coronary intervention should have it performed at least 7 days prior to the treatment of the target lesion.
13. Subject must provide written informed consent.
14. Subject must be willing to comply with the specified follow-up evaluation schedule.
Exclusion Criteria
2. Receiving dialysis or immunosuppressant therapy within the previous 30 days.
3. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
4. Stroke within the previous 90 days.
5. Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
6. Required stent placement via a popliteal approach.
7. Required stent placement across or within 0.5 cm of the SFA/PFA bifurcation.
8. Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.
9. Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
10. Required stent placement within 1 cm of a previously deployed stent.
11. Subject required a coronary intervention, and the coronary intervention was done less than 7 days prior to or planned within 30 days after the treatment of the target lesion.
12. Known allergies to any of the following: aspirin and all three of the following: clopidogrel bisulfate (Plavix®), ticlopidine (Ticlid®), and prasugrel (Effient®); heparin, nitinol (nickel titanium), or contrast agent, that cannot be medically managed.
13. Presence of thrombus prior to crossing the lesion.
14. Known or suspected active infection at the time of the procedure.
15. Presence of an ipsilateral arterial artificial graft.
16. Use of cryoplasty, laser, or atherectomy devices at the time of index procedure.
17. Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.
18. Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
19. History of neutropenia, coagulopathy, or thrombocytopenia that was unexplained or is considered to be at risk for reoccurrence.
20. Known bleeding or hypercoagulability disorder or significant anemia (Hb \< 8.0) that cannot be corrected.
21. Subject has the following laboratory values:
1. platelet count less than 80,000/μL,
2. international normalized ratio (INR) greater than 1.5,
3. serum creatinine level greater than 2.0 mg/dL.
22. Subject requires general anesthesia for the procedure.
23. Subject is pregnant or plans to become pregnant during the study.
24. Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
25. Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. NOTE: Subjects who are participating in the long term follow-up phase of a previously investigational and now FDA-approved product are not excluded by this criterion.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Baim Institute for Clinical Research
OTHER
Abbott Medical Devices
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carol Base, RN,MS
Role: STUDY_DIRECTOR
Abbott Medical Devices
Kenneth Rosenfield, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Lawrence Garcia, MD
Role: PRINCIPAL_INVESTIGATOR
Steward St. Elizabeth's Medical Center of Boston, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cardiology Associates of Mobile, Inc.
Fairhope, Alabama, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
Tucson Medical Center
Tucson, Arizona, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
ACT / CVRI & Cedar Sinai Medical Center
Beverly Hills, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Bradenton Cardiology Center
Bradenton, Florida, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Mount Sinai Medical Cente
Miami Beach, Florida, United States
Clarian North / Heart Partners
Fishers, Indiana, United States
Cardiovascular Research of Northwest Indiana, LLC
Munster, Indiana, United States
Hutchinson Hospital Corporation dba Promise Regional Medical Center
Hutchinson, Kansas, United States
Willis Knighton Bossier Medical Center
Bossier City, Louisiana, United States
Terrebonne General Hospital
Houma, Louisiana, United States
Cardiovascular Institute of the South
Lafayette, Louisiana, United States
Opelousas General Health System
Opelousas, Louisiana, United States
Louisiana Heart Center
Slidell, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
Montgomery General Hospital
Olney, Maryland, United States
Massachussetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Caritas-St. Elizabeth Medical Center
Brighton, Massachusetts, United States
Metro Health Hospital
Wyoming, Michigan, United States
Hattiesburg Clinic, P.A.
Hattiesburg, Mississippi, United States
Deborah Heart
Browns Mills, New Jersey, United States
Hunterdon Medical Center
Flemington, New Jersey, United States
Robert Wood Johnson UMDNJ-RWJMS
New Brunswick, New Jersey, United States
SJH Cardiology Associates
Liverpool, New York, United States
NYU Medical Center
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States
University Hospital
Cleveland, Ohio, United States
Ohio Health Research Institute / Riverside Methodist Hospital
Columbus, Ohio, United States
Heritage Valley Health System
Beaver, Pennsylvania, United States
Cardiology Consultants or Mainline Health System
Bryn Mawr, Pennsylvania, United States
Moffitt Heart & Vascular Group
Wormleysburg, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
Greenville Hospital Systems
Greenville, South Carolina, United States
Forsyth Medical Center - Cardiovascular Research
Winston-Salem, South Carolina, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States
Vanderbilt Medical Center
Nashville, Tennessee, United States
Alice Heart Center
Alice, Texas, United States
Austin Heart, P.A
Austin, Texas, United States
Cardiovascular Specialist of Texas & North Austin Medical Center
Austin, Texas, United States
Cardiovascular Research Institute of Dallas
Dallas, Texas, United States
Plaza Medical Center of Fort Worth
Fort Worth, Texas, United States
North Cascade Cardiology, PLLC
Bellingham, Washington, United States
Columbia - St. Mary's
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Palena LM, Isernia G, Parlani G, Veroux P, Ficarelli I, Frascheri A, Pischedda A, Patrone L, Dionisi CP, Cianni R, Airoldi F, Landino P, Kleiban A, Filauri P, Passalacqua G, Antignani PL, De Rose E, Valls A, Biondi-Zoccai G, Manzi M. A multicenter prospective observational study appraising the effectiveness of the Supera stent after subintimal recanalization of femoro-popliteal artery occlusion: The SUPERSUB II study. Catheter Cardiovasc Interv. 2024 May;103(6):963-971. doi: 10.1002/ccd.31028. Epub 2024 Apr 2.
Garcia L, Jaff MR, Metzger C, Sedillo G, Pershad A, Zidar F, Patlola R, Wilkins RG, Espinoza A, Iskander A, Khammar GS, Khatib Y, Beasley R, Makam S, Kovach R, Kamat S, Leon LR Jr, Eaves WB, Popma JJ, Mauri L, Donohoe D, Base CC, Rosenfield K; SUPERB Trial Investigators. Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries: Twelve-Month Results of the SUPERB Trial. Circ Cardiovasc Interv. 2015 May;8(5):e000937. doi: 10.1161/CIRCINTERVENTIONS.113.000937.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SFA-1 US/EU
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.