Comparison of the SUpera® PERipheral System in the Superficial Femoral Artery

NCT00933270 | Completed Results DMC

• 1 other identifier: SFA-1 US/EU
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 49

Brief Summary

This is a prospective, multicenter, non-randomized, single arm, pivotal trial. 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.

Conditions

Peripheral Vascular Disease

Keywords

Superficial Femoral Artery or SFA

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint: Freedom From Death, Target Lesion Revascularization (TLR), or Any Amputation of the Index Limb to 30 (±7) Days.

  30 days

• Primary Efficacy Endpoint: SFA Patency at 12 Months (± 30 Days), Defined as Freedom From Restenosis (PSVR ≥ 2.0) and TLR.

  Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of \> 2.0 when compared to the proximal normal segment.

  12 months

Secondary Outcomes (85)

• Technical (Lesion) Success

  intraoperative

• Procedural Success

  intraoperative

• Device Success

  intraoperative

• Secondary Safety Composite Endpoint

  12 months (± 30 Days)

• Secondary Safety Endpoint

  24 months (± 30 Days)

Study Arms (1)

SUPERA® Nitinol Stent System

EXPERIMENTAL

Implantation of SUPERA nitinol stent using the SUPERA® Nitinol Stent System

Device: SUPERA® Nitinol Stent System

Interventions

SUPERA® Nitinol Stent System DEVICE

Percutaneous Angioplasty of the Superior Femoral Artery with placement of a SUPERA® Stent at time of PTA

SUPERA® Nitinol Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years and of age of legal consent.
• Women of child bearing potential must have a negative pregnancy test within 7 days prior to the index procedure.
• 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.
• A single superficial femoral artery lesion with greater than 60% stenosis or total occlusion.
• 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.
• 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.
• 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.
• The target lesion(s) can be successfully crossed with a guide wire and dilated.
• 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.
• 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.
• The subject is eligible for standard surgical repair, if necessary.
• A subject who requires a coronary intervention should have it performed at least 7 days prior to the treatment of the target lesion.
• Subject must provide written informed consent.
• Subject must be willing to comply with the specified follow-up evaluation schedule.

You may not qualify if:

• Thrombophlebitis or deep venous thrombus, within the previous 30 days.
• Receiving dialysis or immunosuppressant therapy within the previous 30 days.
• Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
• Stroke within the previous 90 days.
• Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
• Required stent placement via a popliteal approach.
• Required stent placement across or within 0.5 cm of the SFA/PFA bifurcation.
• Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.
• Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
• Required stent placement within 1 cm of a previously deployed stent.
• 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.
• 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.
• Presence of thrombus prior to crossing the lesion.
• Known or suspected active infection at the time of the procedure.
• Presence of an ipsilateral arterial artificial graft.

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Baim Institute for Clinical Research: collaborator

Study Sites (49)

Cardiology Associates of Mobile, Inc.

Fairhope, Alabama, 36532, United States

Location

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States

Location

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

ACT / CVRI & Cedar Sinai Medical Center

Beverly Hills, California, 90210, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Bradenton Cardiology Center

Bradenton, Florida, 34205, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32216, United States

Location

Mount Sinai Medical Cente

Miami Beach, Florida, 33140, United States

Location

Clarian North / Heart Partners

Fishers, Indiana, 46038, United States

Location

Cardiovascular Research of Northwest Indiana, LLC

Munster, Indiana, 46321, United States

Location

Hutchinson Hospital Corporation dba Promise Regional Medical Center

Hutchinson, Kansas, 67502, United States

Location

Willis Knighton Bossier Medical Center

Bossier City, Louisiana, 71111, United States

Location

Terrebonne General Hospital

Houma, Louisiana, 70360, United States

Location

Cardiovascular Institute of the South

Lafayette, Louisiana, 70506, United States

Location

Opelousas General Health System

Opelousas, Louisiana, 70570, United States

Location

Louisiana Heart Center

Slidell, Louisiana, 70458, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Montgomery General Hospital

Olney, Maryland, 20832, United States

Location

Massachussetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Caritas-St. Elizabeth Medical Center

Brighton, Massachusetts, 02135, United States

Location

Metro Health Hospital

Wyoming, Michigan, 49519, United States

Location

Hattiesburg Clinic, P.A.

Hattiesburg, Mississippi, 39401, United States

Location

Deborah Heart

Browns Mills, New Jersey, 08015, United States

Location

Hunterdon Medical Center

Flemington, New Jersey, 08822, United States

Location

Robert Wood Johnson UMDNJ-RWJMS

New Brunswick, New Jersey, 08903, United States

Location

SJH Cardiology Associates

Liverpool, New York, 13088, United States

Location

NYU Medical Center

New York, New York, 10016, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

The Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University Hospital

Cleveland, Ohio, 44104, United States

Location

Ohio Health Research Institute / Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Heritage Valley Health System

Beaver, Pennsylvania, 15009, United States

Location

Cardiology Consultants or Mainline Health System

Bryn Mawr, Pennsylvania, 19010, United States

Location

Moffitt Heart & Vascular Group

Wormleysburg, Pennsylvania, 17043, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Greenville Hospital Systems

Greenville, South Carolina, 29605, United States

Location

Forsyth Medical Center - Cardiovascular Research

Winston-Salem, South Carolina, 27103, United States

Location

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37660, United States

Location

Vanderbilt Medical Center

Nashville, Tennessee, 37232, United States

Location

Alice Heart Center

Alice, Texas, 78332, United States

Location

Austin Heart, P.A

Austin, Texas, 78756, United States

Location

Cardiovascular Specialist of Texas & North Austin Medical Center

Austin, Texas, 78758, United States

Location

Cardiovascular Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

Plaza Medical Center of Fort Worth

Fort Worth, Texas, 76104, United States

Location

North Cascade Cardiology, PLLC

Bellingham, Washington, 98225, United States

Location

Columbia - St. Mary's

Milwaukee, Wisconsin, 53211, United States

Location

Related Publications (2)

• 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.

  PMID: 38566517 DERIVED

• 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.

  PMID: 25969545 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Margo Zaugg
• Organization: Abbott Vascular

margo.zaugg@av.abbott.com

408-845-0576

Study Officials

• Carol Base, RN,MS

  Abbott Medical Devices

  STUDY DIRECTOR

• Kenneth Rosenfield, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Lawrence Garcia, MD

  Steward St. Elizabeth's Medical Center of Boston, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 7, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 30, 2017
• Results First Posted: March 25, 2015

Record last verified: 2017-04

Locations

US (49)