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

Not Applicable

Completed

Conditions: Peripheral Vascular Disease

Interventions: Device: SUPERA® Nitinol Stent System

Registration Number: NCT00933270

Lead Sponsor: Abbott Medical Devices

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 325

Inclusion Criteria

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.

Exclusion Criteria

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.
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:
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.
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SUPERA® Nitinol Stent System	SUPERA® Nitinol Stent System	Implantation of SUPERA nitinol stent using the SUPERA® Nitinol Stent System

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint: SFA Patency at 12 Months (± 30 Days), Defined as Freedom From Restenosis (PSVR ≥ 2.0) and TLR.	12 months	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.
Primary Safety Endpoint: Freedom From Death, Target Lesion Revascularization (TLR), or Any Amputation of the Index Limb to 30 (±7) Days.	30 days

Secondary Outcome Measures

Name	Time	Method
Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)	36 months (± 30 Days)
Technical (Lesion) Success	intraoperative	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.
Device Success	intraoperative	Device success, defined as achievement of a final residual diameter stenosis of \<50% (by QA), using the assigned treatment only.
Secondary Safety Endpoint	36 months (± 30 Days)	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).
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction	12 months (± 30 Days)	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.
Procedural Success	intraoperative	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.
Ankle-brachial Index (ABI) Measurements on Target Limb	1 month (± 7 Days)	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.
Major Adverse Events (MAVE)	36 months (±30 days)	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.
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability	12 months (± 30 Days)	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.
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation	12 months (± 30 Days)	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.
Secondary Safety Composite Endpoint	12 months (± 30 Days)	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).
Target Lesion Revascularization (TLR)	36 months (± 30 Days)	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.
SFA Patency: PSV Ratio > 2.4	12 Months (±30 days)	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.
Quality of Life Assessed (QoL) by SF-12 Questionnaire	Baseline	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.
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation	12 months (± 30 Days)	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.
Clinical Improvement Compared With Baseline: Rutherford Becker Scale	36 Months (± 30 Days)	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
Ankle-brachial Index (ABI) on Target Limb	12 Months (± 30 Days)	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.
SFA Patency: PSV Ratio ≥ 2.0	6 Months (± 14 days)	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.
Limb Ischemia Improvement: Rutherford Becker Scale	36 Months (±30 days)	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.
Index Limb Amputations	36 months (±30 days)	Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.
Quality of Life Assessed by SF-12 Questionnaire	12 Months (± 30 Days)	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.
Exercise Tolerance Test: Claudication Pain Time (CPT)	12 months (± 30 Days)	Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.
Stent Fracture Rate	36 months (± 30 Days)	Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.
Target Vessel Revascularization	36 months (±30 days)	Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 36 months post-procedure.
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms	12 months (± 30 Days)	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.
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life	12 months (± 30 Days)	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.
Clinical Category: Rutherford Becker	36 Months (± 30 Days)	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.
Exercise Tolerance Test: Claudication Pain Distance	12 months	Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.
Exercise Tolerance Test: Maximal Walking Time	12 months (± 30 Days)	Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score	12 months (± 30 Days)	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.
Exercise Tolerance Test: Maximal Walking Distance	12 months (± 30 Days)	Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Trial Locations

Locations (49): Deborah Heart
🇺🇸
Browns Mills, New Jersey, United States
Maine Medical Center
🇺🇸
Portland, Maine, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
University Hospital
🇺🇸
Cleveland, Ohio, United States
Ohio Health Research Institute / Riverside Methodist Hospital
🇺🇸
Columbus, Ohio, United States
Cardiovascular Research of Northwest Indiana, LLC
🇺🇸
Munster, Indiana, United States
Bradenton Cardiology Center
🇺🇸
Bradenton, Florida, United States
Mount Sinai Medical Cente
🇺🇸
Miami Beach, Florida, United States
Caritas-St. Elizabeth Medical Center
🇺🇸
Brighton, Massachusetts, United States
Massachussetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Columbia - St. Mary's
🇺🇸
Milwaukee, Wisconsin, United States
ACT / CVRI & Cedar Sinai Medical Center
🇺🇸
Beverly Hills, California, United States
First Coast Cardiovascular Institute
🇺🇸
Jacksonville, Florida, United States
Plaza Medical Center of Fort Worth
🇺🇸
Fort Worth, Texas, United States
Cardiology Consultants or Mainline Health System
🇺🇸
Bryn Mawr, Pennsylvania, United States
Austin Heart, P.A
🇺🇸
Austin, Texas, United States
Alice Heart Center
🇺🇸
Alice, Texas, United States
Opelousas General Health System
🇺🇸
Opelousas, Louisiana, United States
Lenox Hill Hospital
🇺🇸
New York, New York, United States
Metro Health Hospital
🇺🇸
Wyoming, Michigan, United States
The Lindner Center for Research and Education at The Christ Hospital
🇺🇸
Cincinnati, Ohio, United States
Moffitt Heart & Vascular Group
🇺🇸
Wormleysburg, Pennsylvania, United States
Vanderbilt Medical Center
🇺🇸
Nashville, Tennessee, United States
North Cascade Cardiology, PLLC
🇺🇸
Bellingham, Washington, United States
Cardiovascular Research Institute of Dallas
🇺🇸
Dallas, Texas, United States
Hutchinson Hospital Corporation dba Promise Regional Medical Center
🇺🇸
Hutchinson, Kansas, United States
Cardiology Associates of Mobile, Inc.
🇺🇸
Fairhope, Alabama, United States
Clarian North / Heart Partners
🇺🇸
Fishers, Indiana, United States
Montgomery General Hospital
🇺🇸
Olney, Maryland, United States
SJH Cardiology Associates
🇺🇸
Liverpool, New York, United States
NYU Medical Center
🇺🇸
New York, New York, United States
Heritage Valley Health System
🇺🇸
Beaver, Pennsylvania, United States
Arkansas Heart Hospital
🇺🇸
Little Rock, Arkansas, United States
Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
Banner Good Samaritan Medical Center
🇺🇸
Phoenix, Arizona, United States
Willis Knighton Bossier Medical Center
🇺🇸
Bossier City, Louisiana, United States
Yale University
🇺🇸
New Haven, Connecticut, United States
Cardiovascular Institute of the South
🇺🇸
Lafayette, Louisiana, United States
Louisiana Heart Center
🇺🇸
Slidell, Louisiana, United States
Terrebonne General Hospital
🇺🇸
Houma, Louisiana, United States
Robert Wood Johnson UMDNJ-RWJMS
🇺🇸
New Brunswick, New Jersey, United States
Greenville Hospital Systems
🇺🇸
Greenville, South Carolina, United States
Forsyth Medical Center - Cardiovascular Research
🇺🇸
Winston-Salem, South Carolina, United States
Hattiesburg Clinic, P.A.
🇺🇸
Hattiesburg, Mississippi, United States
Wellmont Holston Valley Medical Center
🇺🇸
Kingsport, Tennessee, United States
Hunterdon Medical Center
🇺🇸
Flemington, New Jersey, United States
The Miriam Hospital
🇺🇸
Providence, Rhode Island, United States
Tucson Medical Center
🇺🇸
Tucson, Arizona, United States
Cardiovascular Specialist of Texas & North Austin Medical Center
🇺🇸
Austin, Texas, United States