Clinical trial NCT00933270: Comparison of the SUpera® PERipheral System in the Superficial Femoral Artery
Official title: Comparison of the SUpera® PERipheral System to a Performance Goal Derived From Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Disease
Keywords: Superficial Femoral Artery or SFA
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Baim Institute for Clinical Research
First posted: 2009-07-07
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age greater than or equal to 18 years and of age of legal consent.
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:

1. Thrombophlebitis or deep venous thrombus, within the previous 30 days.
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.

Primary outcomes:
measure: Primary Safety Endpoint: Freedom From Death, Target Lesion Revascularization (TLR), or Any Amputation of the Index Limb to 30 (±7) Days.
timeFrame: 30 days
measure: Primary Efficacy Endpoint: SFA Patency at 12 Months (± 30 Days), Defined as Freedom From Restenosis (PSVR ≥ 2.0) and TLR.
timeFrame: 12 months
Secondary outcomes:
measure: Technical (Lesion) Success
timeFrame: intraoperative
measure: Procedural Success
timeFrame: intraoperative
measure: Device Success
timeFrame: intraoperative
measure: Secondary Safety Composite Endpoint
timeFrame: 12 months (± 30 Days)
measure: Secondary Safety Endpoint
timeFrame: 24 months (± 30 Days)
measure: Secondary Safety Endpoint
timeFrame: 36 months (± 30 Days)
measure: Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)
timeFrame: 12 months (± 30 Days)
measure: Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)
timeFrame: 24 months (± 30 Days)
measure: Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)
timeFrame: 36 months (± 30 Days)
measure: Stent Fracture Rate
timeFrame: 12 months (± 30 Days)
measure: Stent Fracture Rate
timeFrame: 24 months (± 30 Days)
measure: Stent Fracture Rate
timeFrame: 36 months (± 30 Days)
measure: Ankle-brachial Index (ABI) Measurements on Target Limb
timeFrame: Baseline
measure: Ankle-brachial Index (ABI) Measurements on Target Limb
timeFrame: 1 month (± 7 Days)
measure: Ankle-brachial Index (ABI) on Target Limb
timeFrame: 6 Months (± 14 Days)
measure: Ankle-brachial Index (ABI) on Target Limb
timeFrame: 12 Months (± 30 Days)
measure: Target Lesion Revascularization (TLR)
timeFrame: 6 months (± 14 Days)
measure: Target Lesion Revascularization (TLR)
timeFrame: 12 months (± 30 Days)
measure: Target Lesion Revascularization (TLR)
timeFrame: 24 months (± 30 Days)
measure: Target Lesion Revascularization (TLR)
timeFrame: 36 months (± 30 Days)
measure: SFA Patency: PSV Ratio ≥ 2.0
timeFrame: 6 Months (± 14 days)
measure: SFA Patency: PSV Ratio > 2.4
timeFrame: 6 Months (± 14 days)
measure: SFA Patency: PSV Ratio > 2.4
timeFrame: 12 Months (±30 days)
measure: Target Vessel Revascularization
timeFrame: 6 months (± 14 days)
measure: Target Vessel Revascularization
timeFrame: 12 months (±30 days)
measure: Target Vessel Revascularization
timeFrame: 24 months (±30 days)
measure: Target Vessel Revascularization
timeFrame: 36 months (±30 days)
measure: Limb Ischemia Improvement: Rutherford Becker Scale
timeFrame: 1 month (± 7 days)
measure: Limb Ischemia Improvement: Rutherford Becker Scale
timeFrame: 12 Months (±30 days)
measure: Limb Ischemia Improvement: Rutherford Becker Scale
timeFrame: 24 Months (±30 days)
measure: Limb Ischemia Improvement: Rutherford Becker Scale
timeFrame: 36 Months (±30 days)
measure: Major Adverse Events (MAVE)
timeFrame: 30 days (±7 days)
measure: Major Adverse Events (MAVE)
timeFrame: 6 Months (±14 days)
measure: Major Adverse Events (MAVE)
timeFrame: 12 months (±30 days)
measure: Major Adverse Events (MAVE)
timeFrame: 24 months (±30 days)
measure: Major Adverse Events (MAVE)
timeFrame: 36 months (±30 days)
measure: Index Limb Amputations
timeFrame: 6 months (±14 days)
measure: Index Limb Amputations
timeFrame: 12 months (±30 days)
measure: Index Limb Amputations
timeFrame: 24 months (±30 days)
measure: Index Limb Amputations
timeFrame: 36 months (±30 days)
measure: Quality of Life Assessed (QoL) by SF-12 Questionnaire
timeFrame: Baseline
measure: Quality of Life Assessed by SF-12 Questionnaire
timeFrame: 6 Months (± 14 Days)
measure: Quality of Life Assessed by SF-12 Questionnaire
timeFrame: 12 Months (± 30 Days)
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation
timeFrame: Baseline
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation
timeFrame: 6 months (± 14 Days)
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation
timeFrame: 12 months (± 30 Days)
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms
timeFrame: Baseline
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms
timeFrame: 6 months (± 14 Days)
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms
timeFrame: 12 months (± 30 Days)
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability
timeFrame: Baseline
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability
timeFrame: 6 months (± 14 Days)
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability
timeFrame: 12 months (± 30 Days)
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation
timeFrame: Baseline
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation
timeFrame: 6 months (± 14 Days)
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation
timeFrame: 12 months (± 30 Days)
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction
timeFrame: Baseline
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction
timeFrame: 6 months (± 14 Days)
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction
timeFrame: 12 months (± 30 Days)
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life
timeFrame: Baseline
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life
timeFrame: 6 months (± 14 Days)
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life
timeFrame: 12 months (± 30 Days)
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score
timeFrame: Baseline
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score
timeFrame: 6 months (± 14 Days)
measure: Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score
timeFrame: 12 months (± 30 Days)
measure: Clinical Category: Rutherford Becker
timeFrame: Baseline
measure: Clinical Category: Rutherford Becker
timeFrame: 1 Month (± 7 Days)
measure: Clinical Category: Rutherford Becker
timeFrame: 12 Months (± 30 Days)
measure: Clinical Category: Rutherford Becker
timeFrame: 24 Months (± 30 Days)
measure: Clinical Category: Rutherford Becker
timeFrame: 36 Months (± 30 Days)
measure: Clinical Improvement Compared With Baseline: Rutherford Becker Scale
timeFrame: 1 month (± 7 Days)
measure: Clinical Improvement Compared With Baseline: Rutherford Becker Scale
timeFrame: 12 Months (± 30 Days)
measure: Clinical Improvement Compared With Baseline: Rutherford Becker Scale
timeFrame: 24 Months (± 30 Days)
measure: Clinical Improvement Compared With Baseline: Rutherford Becker Scale
timeFrame: 36 Months (± 30 Days)
measure: Exercise Tolerance Test: Claudication Pain Distance
timeFrame: Baseline
measure: Exercise Tolerance Test: Claudication Pain Distance
timeFrame: 1 month (± 7 Days)
measure: Exercise Tolerance Test: Claudication Pain Distance
timeFrame: 12 months
measure: Exercise Tolerance Test: Claudication Pain Time (CPT)
timeFrame: Baseline
measure: Exercise Tolerance Test: Claudication Pain Time (CPT)
timeFrame: 1 month (± 7 Days)
measure: Exercise Tolerance Test: Claudication Pain Time (CPT)
timeFrame: 12 months (± 30 Days)
measure: Exercise Tolerance Test: Maximal Walking Distance
timeFrame: Baseline
measure: Exercise Tolerance Test: Maximal Walking Distance
timeFrame: 1 month (± 7 Days)
measure: Exercise Tolerance Test: Maximal Walking Distance
timeFrame: 12 months (± 30 Days)
measure: Exercise Tolerance Test: Maximal Walking Time
timeFrame: Baseline
measure: Exercise Tolerance Test: Maximal Walking Time
timeFrame: 1 month (± 7 Days)
measure: Exercise Tolerance Test: Maximal Walking Time
timeFrame: 12 months (± 30 Days)
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: Cardiology Associates of Mobile, Inc.
state: Alabama
city: Phoenix
country: United States
facility: Banner Good Samaritan Medical Center
state: Arizona
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Beverly Hills
country: United States
facility: ACT / CVRI & Cedar Sinai Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Bradenton
country: United States
facility: Bradenton Cardiology Center
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Cente
state: Florida
city: Fishers
country: United States
facility: Clarian North / Heart Partners
state: Indiana
city: Munster
country: United States
facility: Cardiovascular Research of Northwest Indiana, LLC
state: Indiana
city: Hutchinson
country: United States
facility: Hutchinson Hospital Corporation dba Promise Regional Medical Center
state: Kansas
city: Bossier City
country: United States
facility: Willis Knighton Bossier Medical Center
state: Louisiana
city: Houma
country: United States
facility: Terrebonne General Hospital
state: Louisiana
city: Lafayette
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Opelousas
country: United States
facility: Opelousas General Health System
state: Louisiana
city: Slidell
country: United States
facility: Louisiana Heart Center
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Olney
country: United States
facility: Montgomery General Hospital
state: Maryland
city: Boston
country: United States
facility: Massachussetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Brighton
country: United States
facility: Caritas-St. Elizabeth Medical Center
state: Massachusetts
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic, P.A.
state: Mississippi
city: Browns Mills
country: United States
facility: Deborah Heart
state: New Jersey
city: Flemington
country: United States
facility: Hunterdon Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson UMDNJ-RWJMS
state: New Jersey
city: Liverpool
country: United States
facility: SJH Cardiology Associates
state: New York
city: New York
country: United States
facility: NYU Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Cincinnati
country: United States
facility: The Lindner Center for Research and Education at The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute / Riverside Methodist Hospital
state: Ohio
city: Beaver
country: United States
facility: Heritage Valley Health System
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Cardiology Consultants or Mainline Health System
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Moffitt Heart & Vascular Group
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Greenville
country: United States
facility: Greenville Hospital Systems
state: South Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center - Cardiovascular Research
state: South Carolina
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Alice
country: United States
facility: Alice Heart Center
state: Texas
city: Austin
country: United States
facility: Austin Heart, P.A
state: Texas
city: Austin
country: United States
facility: Cardiovascular Specialist of Texas & North Austin Medical Center
state: Texas
city: Dallas
country: United States
facility: Cardiovascular Research Institute of Dallas
state: Texas
city: Fort Worth
country: United States
facility: Plaza Medical Center of Fort Worth
state: Texas
city: Bellingham
country: United States
facility: North Cascade Cardiology, PLLC
state: Washington
city: Milwaukee
country: United States
facility: Columbia - St. Mary's
state: Wisconsin
Study officials:
affiliation: Abbott Medical Devices
name: Carol Base, RN,MS
role: STUDY_DIRECTOR
affiliation: Massachusetts General Hospital
name: Kenneth Rosenfield, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Steward St. Elizabeth's Medical Center of Boston, Inc.
name: Lawrence Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.