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Peripheral Vascular DiseaseSUPERBNCT00933270

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

A study testing SUPERA® Nitinol Stent System in people with Peripheral Vascular Disease, run by Abbott Medical Devices at 49 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Vascular Disease
What is being tested?
SUPERA® Nitinol Stent System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
325 participants
Where
49 sitesUnited States
Study dates
Jul 2009to Jul 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Use of cryoplasty, laser, or atherectomy devices at the time of index procedure.
  • Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.
  • Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
  • History of neutropenia, coagulopathy, or thrombocytopenia that was unexplained or is considered to be at risk for reoccurrence.
  • Known bleeding or hypercoagulability disorder or significant anemia (Hb < 8.0) that cannot be corrected.
  • Subject has the following laboratory values:
  • platelet count less than 80,000/μL,
  • international normalized ratio (INR) greater than 1.5,
  • serum creatinine level greater than 2.0 mg/dL.
  • Subject requires general anesthesia for the procedure.
  • Subject is pregnant or plans to become pregnant during the study.
  • Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
  • 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.

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

United States49 sites

  • Alice Heart Center

    Alice, Texas, 78332

  • Austin Heart, P.A

    Austin, Texas, 78756

  • Cardiovascular Specialist of Texas & North Austin Medical Center

    Austin, Texas, 78758

  • Heritage Valley Health System

    Beaver, Pennsylvania, 15009

  • North Cascade Cardiology, PLLC

    Bellingham, Washington, 98225

  • ACT / CVRI & Cedar Sinai Medical Center

    Beverly Hills, California, 90210

  • Willis Knighton Bossier Medical Center

    Bossier City, Louisiana, 71111

  • Massachussetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Bradenton Cardiology Center

    Bradenton, Florida, 34205

  • Caritas-St. Elizabeth Medical Center

    Brighton, Massachusetts, 02135

  • Deborah Heart

    Browns Mills, New Jersey, 08015

  • Cardiology Consultants or Mainline Health System

    Bryn Mawr, Pennsylvania, 19010

  • The Lindner Center for Research and Education at The Christ Hospital

    Cincinnati, Ohio, 45219

  • University Hospital

    Cleveland, Ohio, 44104

  • Ohio Health Research Institute / Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Cardiovascular Research Institute of Dallas

    Dallas, Texas, 75231

  • Cardiology Associates of Mobile, Inc.

    Fairhope, Alabama, 36532

  • Clarian North / Heart Partners

    Fishers, Indiana, 46038

  • Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Plaza Medical Center of Fort Worth

    Fort Worth, Texas, 76104

  • Greenville Hospital Systems

    Greenville, South Carolina, 29605

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Hattiesburg Clinic, P.A.

    Hattiesburg, Mississippi, 39401

  • Terrebonne General Hospital

    Houma, Louisiana, 70360

  • Hutchinson Hospital Corporation dba Promise Regional Medical Center

    Hutchinson, Kansas, 67502

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32216

  • Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37660

  • Cardiovascular Institute of the South

    Lafayette, Louisiana, 70506

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • SJH Cardiology Associates

    Liverpool, New York, 13088

  • Mount Sinai Medical Cente

    Miami Beach, Florida, 33140

  • Columbia - St. Mary's

    Milwaukee, Wisconsin, 53211

  • Cardiovascular Research of Northwest Indiana, LLC

    Munster, Indiana, 46321

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37232

  • Robert Wood Johnson UMDNJ-RWJMS

    New Brunswick, New Jersey, 08903

  • Yale University

    New Haven, Connecticut, 06510

  • NYU Medical Center

    New York, New York, 10016

  • Lenox Hill Hospital

    New York, New York, 10075

  • Montgomery General Hospital

    Olney, Maryland, 20832

  • Opelousas General Health System

    Opelousas, Louisiana, 70570

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006

  • Maine Medical Center

    Portland, Maine, 04102

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Louisiana Heart Center

    Slidell, Louisiana, 70458

  • Tucson Medical Center

    Tucson, Arizona, 85712

  • Forsyth Medical Center - Cardiovascular Research

    Winston-Salem, South Carolina, 27103

  • Moffitt Heart & Vascular Group

    Wormleysburg, Pennsylvania, 17043

  • Metro Health Hospital

    Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: Comparison of the SUpera® PERipheral System to a Performance Goal Derived From Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery

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.

Being tested
SUPERA® Nitinol Stent System
Keywords
Superficial Femoral Artery or SFA
Medical subject headings
Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SUPERA® Nitinol Stent SystemDevice

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

Study groups in NCT00933270
Study groupRoleWhat they receive
SUPERA® Nitinol Stent SystemExperimentalImplantation of SUPERA nitinol stent using the SUPERA® Nitinol Stent System
Receives: Device: SUPERA® Nitinol Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 30 days

  2. 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.

    Measured: 12 months

Secondary outcomes (85)

  1. Technical (Lesion) Success

    Technical (lesion) success, defined as the attainment of <50% residual stenosis by Quantitative Angiography (QA) by any percutaneous method as determined by the Angiographic core laboratory.

    Measured: intraoperative

  2. Procedural Success

    Defined as device success with < 50% residual stenosis immediately after stent placement, mean trans-stenotic pressure gradient less than 5 mmHg, and without the occurrence of death, amputation or repeat revascularization of the target lesion during the hospital stay.

    Measured: intraoperative

  3. Device Success

    Device success, defined as achievement of a final residual diameter stenosis of <50% (by QA), using the assigned treatment only.

    Measured: intraoperative

  4. Secondary Safety Composite Endpoint

    Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes at 12 months (± 30 Days) (comparing pre- to post-procedural assessments).

    Measured: 12 months (± 30 Days)

  5. Secondary Safety Endpoint

    Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes (comparing pre- to post-procedural assessments).

    Measured: 24 months (± 30 Days)

  6. Secondary Safety Endpoint

    Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes at 36 months (± 30 Days)(comparing pre- to post-procedural assessments).

    Measured: 36 months (± 30 Days)

  7. Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)

    Measured: 12 months (± 30 Days)

  8. Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)

    Measured: 24 months (± 30 Days)

  9. Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)

    Measured: 36 months (± 30 Days)

  10. Stent Fracture Rate

    Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.

    Stent fracture classification

    • Type I - a single strut fracture only.
    • Type II - multiple single nitinol stent fractures that can occur at different sites.
    • Type III - multiple nitinol stent fractures resulting in complete transverse linear fracture but without stent displacement.
    • Type IV - a complete transverse linear type III fracture with stent displacement.
    • Type V - a spiral dissection of a stent.

    Measured: 12 months (± 30 Days)

  11. Stent Fracture Rate

    Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.

    Measured: 24 months (± 30 Days)

  12. Stent Fracture Rate

    Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.

    Measured: 36 months (± 30 Days)

  13. Ankle-brachial Index (ABI) Measurements on Target Limb

    A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.

    Measured: Baseline

  14. Ankle-brachial Index (ABI) Measurements on Target Limb

    A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.

    Measured: 1 month (± 7 Days)

  15. Ankle-brachial Index (ABI) on Target Limb

    A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.

    Measured: 6 Months (± 14 Days)

  16. Ankle-brachial Index (ABI) on Target Limb

    A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.

    Measured: 12 Months (± 30 Days)

  17. Target Lesion Revascularization (TLR)

    Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.

    Measured: 6 months (± 14 Days)

  18. Target Lesion Revascularization (TLR)

    Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.

    Measured: 12 months (± 30 Days)

  19. Target Lesion Revascularization (TLR)

    Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.

    Measured: 24 months (± 30 Days)

  20. Target Lesion Revascularization (TLR)

    Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.

    Measured: 36 months (± 30 Days)

  21. SFA Patency: PSV Ratio ≥ 2.0

    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.

    Measured: 6 Months (± 14 days)

  22. SFA Patency: PSV Ratio > 2.4

    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.

    Measured: 6 Months (± 14 days)

  23. SFA Patency: PSV Ratio > 2.4

    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.

    Measured: 12 Months (±30 days)

  24. Target Vessel Revascularization

    Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 6 months post-procedure.

    Measured: 6 months (± 14 days)

  25. Target Vessel Revascularization

    Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 12 months post-procedure.

    Measured: 12 months (±30 days)

  26. Target Vessel Revascularization

    Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 24 months post-procedure.

    Measured: 24 months (±30 days)

  27. Target Vessel Revascularization

    Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 36 months post-procedure.

    Measured: 36 months (±30 days)

  28. Limb Ischemia Improvement: Rutherford Becker Scale

    Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.

    Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.

    Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.

    Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).

    Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.

    Grade -2 = Moderate worsening. Deterioration of the subject's condition by one category or unexpected minor amputation.

    Grade -3 = Marked worsening. Deterioration of the subject's condition by more than one category or major amputation.

    Measured: 1 month (± 7 days)

  29. Limb Ischemia Improvement: Rutherford Becker Scale

    Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.

    Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.

    Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.

    Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).

    Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.

    Grade -2 = Moderate worsening. Deterioration of the subject's condition by one category or unexpected minor amputation.

    Grade -3 = Marked worsening. Deterioration of the subject's condition by more than one category or major amputation.

    Measured: 12 Months (±30 days)

  30. Limb Ischemia Improvement: Rutherford Becker Scale

    Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.

    Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.

    Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.

    Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).

    Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.

    Grade -2 = Moderate worsening. Deterioration of the subject's condition by one category or unexpected minor amputation.

    Grade -3 = Marked worsening. Deterioration of the subject's condition by more than one category or major amputation.

    Measured: 24 Months (±30 days)

  31. Limb Ischemia Improvement: Rutherford Becker Scale

    Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.

    Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.

    Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.

    Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).

    Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.

    Grade -2 = Moderate worsening. Deterioration of the subject's condition by one category or unexpected minor amputation.

    Grade -3 = Marked worsening. Deterioration of the subject's condition by more than one category or major amputation.

    Measured: 36 Months (±30 days)

  32. Major Adverse Events (MAVE)

    Defined as a composite rate of

    1. stent thrombosis,
    2. clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),
    3. procedure-related arterial rupture,
    4. acute limb ischemia,
    5. target limb amputation,
    6. procedure related bleeding event requiring transfusion.

    Measured: 30 days (±7 days)

  33. Major Adverse Events (MAVE)

    Defined as a composite rate of

    1. stent thrombosis,
    2. clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),
    3. procedure-related arterial rupture,
    4. acute limb ischemia,
    5. target limb amputation,
    6. procedure related bleeding event requiring transfusion.

    Measured: 6 Months (±14 days)

  34. Major Adverse Events (MAVE)

    Defined as a composite rate of

    1. stent thrombosis,
    2. clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),
    3. procedure-related arterial rupture,
    4. acute limb ischemia,
    5. target limb amputation,
    6. procedure related bleeding event requiring transfusion.

    Measured: 12 months (±30 days)

  35. Major Adverse Events (MAVE)

    Defined as a composite rate of

    1. stent thrombosis,
    2. clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),
    3. procedure-related arterial rupture,
    4. acute limb ischemia,
    5. target limb amputation,
    6. procedure related bleeding event requiring transfusion.

    Measured: 24 months (±30 days)

  36. Major Adverse Events (MAVE)

    Defined as a composite rate of

    1. stent thrombosis,
    2. clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),
    3. procedure-related arterial rupture,
    4. acute limb ischemia,
    5. target limb amputation,
    6. procedure related bleeding event requiring transfusion.

    Measured: 36 months (±30 days)

  37. Index Limb Amputations

    Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.

    Measured: 6 months (±14 days)

  38. Index Limb Amputations

    Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.

    Measured: 12 months (±30 days)

  39. Index Limb Amputations

    Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.

    Measured: 24 months (±30 days)

  40. Index Limb Amputations

    Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.

    Measured: 36 months (±30 days)

  41. Quality of Life Assessed (QoL) by SF-12 Questionnaire

    The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL. SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.

    Measured: Baseline

  42. Quality of Life Assessed by SF-12 Questionnaire

    The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL.SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.

    Measured: 6 Months (± 14 Days)

  43. Quality of Life Assessed by SF-12 Questionnaire

    The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL.SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.

    Measured: 12 Months (± 30 Days)

  44. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation

    The PAQ assesses Peripheral arterial disease (PAD)-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: Baseline

  45. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: 6 months (± 14 Days)

  46. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: 12 months (± 30 Days)

  47. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: Baseline

  48. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: 6 months (± 14 Days)

  49. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: 12 months (± 30 Days)

  50. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: Baseline

  51. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: 6 months (± 14 Days)

  52. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: 12 months (± 30 Days)

  53. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: Baseline

  54. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: 6 months (± 14 Days)

  55. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: 12 months (± 30 Days)

  56. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: Baseline

  57. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: 6 months (± 14 Days)

  58. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: 12 months (± 30 Days)

  59. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: Baseline

  60. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: 6 months (± 14 Days)

  61. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: 12 months (± 30 Days)

  62. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: Baseline

  63. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: 6 months (± 14 Days)

  64. Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score

    The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

    Measured: 12 months (± 30 Days)

  65. Clinical Category: Rutherford Becker

    Category and Clinical Description

    0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.

    Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction.

    Measured: Baseline

  66. Clinical Category: Rutherford Becker

    Category and Clinical Description

    0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.

    Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction.

    Measured: 1 Month (± 7 Days)

  67. Clinical Category: Rutherford Becker

    Category and Clinical Description

    0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.

    Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction.

    Measured: 12 Months (± 30 Days)

  68. Clinical Category: Rutherford Becker

    Category and Clinical Description

    0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.

    Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction.

    Measured: 24 Months (± 30 Days)

  69. Clinical Category: Rutherford Becker

    Category and Clinical Description

    0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.

    Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction.

    Measured: 36 Months (± 30 Days)

  70. Clinical Improvement Compared With Baseline: Rutherford Becker Scale

    Clinical Improvement Compared With Baseline

    Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening

    Measured: 1 month (± 7 Days)

  71. Clinical Improvement Compared With Baseline: Rutherford Becker Scale

    Clinical Improvement Compared With Baseline

    Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening

    Measured: 12 Months (± 30 Days)

  72. Clinical Improvement Compared With Baseline: Rutherford Becker Scale

    Clinical Improvement Compared With Baseline

    Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening

    Measured: 24 Months (± 30 Days)

  73. Clinical Improvement Compared With Baseline: Rutherford Becker Scale

    Clinical Improvement Compared With Baseline

    Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening

    Measured: 36 Months (± 30 Days)

  74. Exercise Tolerance Test: Claudication Pain Distance

    Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

    Measured: Baseline

  75. Exercise Tolerance Test: Claudication Pain Distance

    Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

    Measured: 1 month (± 7 Days)

  76. Exercise Tolerance Test: Claudication Pain Distance

    Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

    Measured: 12 months

  77. Exercise Tolerance Test: Claudication Pain Time (CPT)

    Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

    Measured: Baseline

  78. Exercise Tolerance Test: Claudication Pain Time (CPT)

    Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

    Measured: 1 month (± 7 Days)

  79. Exercise Tolerance Test: Claudication Pain Time (CPT)

    Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

    Measured: 12 months (± 30 Days)

  80. Exercise Tolerance Test: Maximal Walking Distance

    Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

    Measured: Baseline

  81. Exercise Tolerance Test: Maximal Walking Distance

    Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

    Measured: 1 month (± 7 Days)

  82. Exercise Tolerance Test: Maximal Walking Distance

    Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

    Measured: 12 months (± 30 Days)

  83. Exercise Tolerance Test: Maximal Walking Time

    Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

    Measured: Baseline

  84. Exercise Tolerance Test: Maximal Walking Time

    Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

    Measured: 1 month (± 7 Days)

  85. Exercise Tolerance Test: Maximal Walking Time

    Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

    Measured: 12 months (± 30 Days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionMay 2014
  4. Study completionJul 2014

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
325 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00933270
Sponsor's protocol ID
SFA-1 US/EU
Acronym
SUPERB
Status last verified
Apr 2017
First submitted
2 Jul 2009
Last updated
30 May 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 38566517

  • 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.

    PubMed 25969545

Questions about this trial

What is this clinical trial studying?

A study testing SUPERA® Nitinol Stent System in people with Peripheral Vascular Disease, run by Abbott Medical Devices at 49 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 14 inclusion and 28 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 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?

Yes. Results are posted in the registry (first posted 25 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Primary Safety Endpoint: Freedom From Death, Target Lesion Revascularization (TLR), or Any Amputation of the Index Limb to 30 (±7) Days. (time frame: 30 days). The study lists 2 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 NCT00933270, which also lists 2 linked publications.

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 30 May 2017.

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