Comparison of the SUpera® PERipheral System in the Superficial Femoral Artery (SUPERB)

This study has been completed.
Sponsor:
Collaborator:
Harvard Clinical Research Institute
Information provided by (Responsible Party):
IDev Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00933270
First received: July 2, 2009
Last updated: May 7, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Peripheral Vascular Disease
Device: SUPERA® Nitinol Stent System
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of the SUpera® PERipheral System to a Performance Goal Derived From Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery

Resource links provided by NLM:


Further study details as provided by IDev Technologies, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Primary Efficacy Endpoint: SFA Patency at 12 Months (± 30 Days), Defined as Freedom From Restenosis (PSVR ≥ 2.0) and TLR. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Technical (Lesion) Success [ Time Frame: intraoperative ] [ Designated as safety issue: Yes ]
    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.

  • Procedural Success [ Time Frame: intraoperative ] [ Designated as safety issue: Yes ]
    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.

  • Device Success [ Time Frame: intraoperative ] [ Designated as safety issue: Yes ]
    Device success, defined as achievement of a final residual diameter stenosis of <50% (by QA), using the assigned treatment only.

  • Secondary Safety Composite Endpoint [ Time Frame: 12 months (± 30 Days) ] [ Designated as safety issue: Yes ]
    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).

  • Secondary Safety Endpoint [ Time Frame: 24 months (± 30 Days) ] [ Designated as safety issue: Yes ]
    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).

  • Stent Fracture Rate [ Time Frame: 12 months (± 30 Days) ] [ Designated as safety issue: Yes ]

    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.

  • Stent Fracture Rate [ Time Frame: 24 months (± 30 Days) ] [ Designated as safety issue: Yes ]
    Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.

  • Ankle-brachial Index (ABI) Measurements on Target Limb [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Ankle-brachial Index (ABI) Measurements on Target Limb [ Time Frame: 1 month (± 7 Days) ] [ Designated as safety issue: No ]
    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.

  • Ankle-brachial Index (ABI) on Target Limb [ Time Frame: 6 Months (± 14 Days) ] [ Designated as safety issue: No ]
    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.

  • Ankle-brachial Index (ABI) on Target Limb [ Time Frame: 12 Months (± 30 Days) ] [ Designated as safety issue: No ]
    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.

  • Target Lesion Revascularization (TLR) [ Time Frame: 6 months (± 14 Days) ] [ Designated as safety issue: Yes ]
    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.

  • Target Lesion Revascularization (TLR) [ Time Frame: 12 months (± 30 Days) ] [ Designated as safety issue: Yes ]
    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.

  • Target Lesion Revascularization (TLR) [ Time Frame: 24 months (± 30 Days) ] [ Designated as safety issue: Yes ]
    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 < 2.0 [ Time Frame: 6 Months (± 14 days) ] [ Designated as safety issue: No ]
    Defined as freedom from restenosis [defined as diameter stenosis >50% with a peak systolic velocity (PSV) ratio ≥ 2.0 as measured by duplex ultrasound] and TLR

  • SFA Patency: PSV Ratio ≤ 2.4 [ Time Frame: 6 Months (± 14 days) ] [ Designated as safety issue: No ]
    Defined as freedom from restenosis [defined as diameter stenosis >50% with a peak systolic velocity (PSV) ratio > 2.4 as measured by duplex ultrasound] and TLR

  • SFA Patency: PSV Ratio ≤ 2.4 [ Time Frame: 12 Months (±30 days) ] [ Designated as safety issue: No ]
    Defined as freedom from restenosis [defined as diameter stenosis >50% with a peak systolic velocity (PSV) ratio > 2.4 as measured by duplex ultrasound] and TLR

  • Target Vessel Revascularization [ Time Frame: 6 months (± 14 days) ] [ Designated as safety issue: Yes ]
    Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 6 months post-procedure.

  • Target Vessel Revascularization [ Time Frame: 12 months (±30 days) ] [ Designated as safety issue: Yes ]
    Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 12 months post-procedure.

  • Target Vessel Revascularization [ Time Frame: 24 months (±30 days) ] [ Designated as safety issue: Yes ]
    Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 24 months post-procedure.

  • Limb Ischemia Improvement: Rutherford Becker Scale [ Time Frame: 1 month (± 7 days) ] [ Designated as safety issue: No ]

    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.


  • Limb Ischemia Improvement: Rutherford Becker Scale [ Time Frame: 12 Months (±30 days) ] [ Designated as safety issue: No ]

    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.


  • Limb Ischemia Improvement: Rutherford Becker Scale [ Time Frame: 24 Months (±30 days) ] [ Designated as safety issue: No ]

    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.


  • Major Adverse Events (MAVE) [ Time Frame: 30 days (±7 days) ] [ Designated as safety issue: Yes ]

    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.

  • Major Adverse Events (MAVE) [ Time Frame: 6 Months (±14 days) ] [ Designated as safety issue: Yes ]

    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.

  • Major Adverse Events (MAVE) [ Time Frame: 12 months (±30 days) ] [ Designated as safety issue: Yes ]

    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.

  • Major Adverse Events (MAVE) [ Time Frame: 24 months (±30 days) ] [ Designated as safety issue: Yes ]

    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.

  • Index Limb Amputations [ Time Frame: 6 months (±14 days) ] [ Designated as safety issue: Yes ]
    Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.

  • Index Limb Amputations [ Time Frame: 12 months (±30 days) ] [ Designated as safety issue: Yes ]
    Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.

  • Index Limb Amputations [ Time Frame: 24 months (±30 days) ] [ Designated as safety issue: Yes ]
    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 (QoL) by SF-12 Questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 SF-12 Questionnaire [ Time Frame: 6 Months (± 14 Days) ] [ Designated as safety issue: No ]
    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 SF-12 Questionnaire [ Time Frame: 12 Months (± 30 Days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation [ Time Frame: 6 months (± 14 Days) ] [ Designated as safety issue: No ]
    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): Physical Limitation [ Time Frame: 12 months (± 30 Days) ] [ Designated as safety issue: No ]
    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): Symptoms [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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): Symptoms [ Time Frame: 6 months (± 14 Days) ] [ Designated as safety issue: No ]
    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): Symptoms [ Time Frame: 12 months (± 30 Days) ] [ Designated as safety issue: No ]
    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): Symptom Stability [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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): Symptom Stability [ Time Frame: 6 months (± 14 Days) ] [ Designated as safety issue: No ]
    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): Symptom Stability [ Time Frame: 12 months (± 30 Days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months (± 14 Days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months (± 30 Days) ] [ Designated as safety issue: No ]
    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): Treatment Satisfaction [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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): Treatment Satisfaction [ Time Frame: 6 months (± 14 Days) ] [ Designated as safety issue: No ]
    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): Treatment Satisfaction [ Time Frame: 12 months (± 30 Days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months (± 14 Days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months (± 30 Days) ] [ Designated as safety issue: No ]
    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): Summary Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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): Summary Score [ Time Frame: 6 months (± 14 Days) ] [ Designated as safety issue: No ]
    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): Summary Score [ Time Frame: 12 months (± 30 Days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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


  • Clinical Category: Rutherford Becker [ Time Frame: 1 Month (± 7 Days) ] [ Designated as safety issue: No ]

    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


  • Clinical Category: Rutherford Becker [ Time Frame: 12 Months (± 30 Days) ] [ Designated as safety issue: No ]

    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


  • Clinical Category: Rutherford Becker [ Time Frame: 24 Months (± 30 Days) ] [ Designated as safety issue: No ]

    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


  • Clinical Improvement Compared With Baseline: Rutherford Becker Scale [ Time Frame: 1 month (± 7 Days) ] [ Designated as safety issue: No ]

    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


  • Clinical Improvement Compared With Baseline: Rutherford Becker Scale [ Time Frame: 12 Months (± 30 Days) ] [ Designated as safety issue: No ]

    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


  • Clinical Improvement Compared With Baseline: Rutherford Becker Scale [ Time Frame: 24 Months (± 30 Days) ] [ Designated as safety issue: No ]

    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


  • Exercise Tolerance Test: Claudication Pain Distance [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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: Claudication Pain Distance [ Time Frame: 1 month (± 7 Days) ] [ Designated as safety issue: No ]
    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: Claudication Pain Distance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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: Claudication Pain Time (CPT) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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: Claudication Pain Time (CPT) [ Time Frame: 1 month (± 7 Days) ] [ Designated as safety issue: No ]
    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: Claudication Pain Time (CPT) [ Time Frame: 12 months (± 30 Days) ] [ Designated as safety issue: No ]
    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 Distance [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 Distance [ Time Frame: 1 month (± 7 Days) ] [ Designated as safety issue: No ]
    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 Distance [ Time Frame: 12 months (± 30 Days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month (± 7 Days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months (± 30 Days) ] [ Designated as safety issue: No ]
    Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.


Enrollment: 325
Study Start Date: July 2009
Study Completion Date: July 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SUPERA® Nitinol Stent System
Implantation of SUPERA nitinol stent using the SUPERA® Nitinol Stent System
Device: SUPERA® Nitinol Stent System
Percutaneous Angioplasty of the Superior Femoral Artery with placement of a SUPERA® Stent at time of PTA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933270

  Show 49 Study Locations
Sponsors and Collaborators
IDev Technologies, Inc.
Harvard Clinical Research Institute
Investigators
Study Director: Carol Base, RN,MS IDev Technologies, Inc.
Principal Investigator: Kenneth Rosenfield, MD Massachusetts General Hospital
Principal Investigator: Lawrence Garcia, MD Steward St. Elizabeth's Medical Center of Boston, Inc.
  More Information

No publications provided by IDev Technologies, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: IDev Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00933270     History of Changes
Other Study ID Numbers: SFA-1 US/EU
Study First Received: July 2, 2009
Results First Received: April 8, 2014
Last Updated: May 7, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by IDev Technologies, Inc.:
Superficial Femoral Artery or SFA

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 30, 2015