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Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)

Primary Purpose

Peripheral Arterial Disease, Claudication, Critical Limb Ischemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SilverHawk & TurboHawk Peripheral Plaque Excision System
Sponsored by
Medtronic Endovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring PAD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Has a Rutherford Clinical Category Score of 1 - 6.
  • Has evidence of ≥ 50% stenosis or occlusion in the superficial femoral, popliteal, anterior tibial, posterior tibial and/or peroneal arteries, confirmed by angiography.
  • Has identifiable distal target vessel which upon completion of the intervention, is anticipated to provide re-constitution of blood flow to the foot.
  • Exchangeable guidewire must cross lesion(s), with ability of catheter to cross lesion.
  • Each discrete target lesion's length is ≤ 20 cm.
  • Reference vessel diameter is ≥ 1.5 mm and ≤ 7 mm.

Exclusion Criteria

  • Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure.
  • Has any planned surgical intervention or endovascular procedure within 30 days after the index procedure.
  • Has had a previous peripheral bypass affecting the target limb.
  • Has end-stage renal disease defined as undergoing hemodialysis for kidney failure.
  • Has presence of severe calcification in target lesion(s).
  • Has in-stent restenosis of the target lesion.
  • Has an aneurysmal target vessel.
  • Has significant stenosis or occlusion of inflow tract that has not been revascularized prior to treatment of the target vessel.
  • Has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment.
  • Has disease that precludes safe advancement of the SilverHawk/TurboHawk device to the target lesion(s).
  • Has had a previous amputation above the metatarsal line on the target limb.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Atherectomy

    Arm Description

    All patients enrolled in this single-arm study were treated with directional atherectomy.

    Outcomes

    Primary Outcome Measures

    Primary Patency Rate (in Patients Treated for Claudication RCC 1-3)
    The primary endpoint analysis for claudication subjects was primary patency rate at one year, defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who had claudication (RCC of 1 - 3) at time of enrollment.
    Amputation-Free Survival at 1 Year (in Patients Treated for Critical Limb Ischemia RCC 4-6)
    The primary endpoint for CLI was amputation-free survival at one year, defined as freedom from a major, unplanned amputation of the target limb through the 1-year visit in subjects who have CLI (RCC 4 - 6) at time of enrollment.

    Secondary Outcome Measures

    Device Success (in All Patients Enrolled)
    Device success was defined as ≤ 30% residual stenosis following use of the SilverHawk device, as measured by angiography, without adjunctive endovascular interventions or periprocedural complications.
    Procedural Success (in All Patients Enrolled)
    Procedure success was defined as ≤ 30% residual stenosis following use of SilverHawk device and adjunctive endovascular interventions (if required) as measured by angiography without periprocedural complications.
    Major Adverse Event Rate (in All Patients Enrolled)
    Major Adverse Event Rate (MAE) at 30 Days was defined as clinically-driven target vessel revascularization (TVR), major unplanned amputation of treated limb, or all-cause mortality within 30 days post procedure, as classified by the Clinical Events Committee (CEC).
    Major Adverse Event Rate (in All Patients Enrolled)
    Major Adverse Event Rate at One Year was defined as clinically-driven target vessel revascularization, major unplanned amputation of the treated limb, or all-cause mortality within one year, as classified by the Clinical Events Committee (CEC).
    Improvement in Walking Impairment Questionnaire Score (in Patients Treated for Claudication RCC 1-3)
    WIQ includes a measurement for walking distance, walking speed, and climbing stairs collected at baseline and one year, presented for subjects who have claudication. The Walking Improvement Questionnaire (WIQ) is a validated method to assess objective improvement in functional walking ability of subjects with intermittent claudication. Difficulty walking a distance was self-assessed at baseline by the patient (prior to treatment) and at the one year follow up visit. Speed and stair climbing ability were assessed by the treating physician. Scale ranges from 0 (minimum) to 100 (maximum), with larger numbers representing better outcomes. An increase in WIQ scores at 1 year represents an improvement over baseline.
    Improvement in Rutherford Clinical Category (in All Patients Enrolled)
    Change in RCC at One Year was assessed and percentage of subjects with an improvement in clinical status indicated by a decrease of one or more in RCC at one year compared to baseline, that is attributable to the treated limb (in cases of bilateral disease), was calculated.
    Ankle-Brachial Index (in All Patients Enrolled)
    Change in Ankle-Brachial Index at One Year was calculated and percentage of subjects with an increase (improvement) in the ankle-brachial index (ABI) at one year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9 was calculated.
    Secondary Patency (in Patients Treated for Claudication RCC 1-3)
    Secondary patency was defined as measured by duplex ultrasound peak systolic velocity ratio ≤ 3.5 maintained by repeat percutaneous intervention in subjects who have claudication; estimated as freedom from loss of patency by the Kaplan-Meier method at one year.
    Primary Patency (in Patients Treated for Critical Limb Ischemia RCC 4-6)
    The primary patency for CLI was defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who have CLI at time of enrollment
    Amputation-Free Survival (in Patients Treated for Claudication RCC 1-3)
    Amputation-Free Survival in Claudicants at One Year was defined as freedom from a major, unplanned amputation of the target limb through the one year visit in subjects who have claudication at time of enrollment.
    Improvement in Wound Healing (in Patients Treated for Critical Limb Ischemia and With Wounds RCC 5-6)
    Wound healing at three months was defined as a decrease of at least one Wagner Classification grade of the wound at three months compared to baseline in subjects who have Rutherford Clinical Category score of 5 or 6 at the time of enrollment.
    Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) at 1 Year (in Patients Treated for Claudication RCC 1-3)
    Defined by the duplex ultrasound measurement of peak systolic velocity ration ≤ 2.4 at the target lesion (s) with no clinically-driven re- intervention with the treated segment in subjects who have claudication at time of enrollment.

    Full Information

    First Posted
    April 16, 2009
    Last Updated
    May 23, 2019
    Sponsor
    Medtronic Endovascular
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00883246
    Brief Title
    Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)
    Official Title
    Determination of Effectiveness of SilverHawk Peripheral Plaque Excision (SilverHawk Device) for the Treatment of Infrainguinal Vessels/Lower Extremities
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2009 (undefined)
    Primary Completion Date
    June 2012 (Actual)
    Study Completion Date
    June 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medtronic Endovascular

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
    Keywords
    PAD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    800 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Atherectomy
    Arm Type
    Other
    Arm Description
    All patients enrolled in this single-arm study were treated with directional atherectomy.
    Intervention Type
    Device
    Intervention Name(s)
    SilverHawk & TurboHawk Peripheral Plaque Excision System
    Other Intervention Name(s)
    SilverHawk (Atherectomy), TurboHawk (Atherectomy)
    Intervention Description
    Removal of atherosclerotic plaque from artery walls.
    Primary Outcome Measure Information:
    Title
    Primary Patency Rate (in Patients Treated for Claudication RCC 1-3)
    Description
    The primary endpoint analysis for claudication subjects was primary patency rate at one year, defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who had claudication (RCC of 1 - 3) at time of enrollment.
    Time Frame
    One year
    Title
    Amputation-Free Survival at 1 Year (in Patients Treated for Critical Limb Ischemia RCC 4-6)
    Description
    The primary endpoint for CLI was amputation-free survival at one year, defined as freedom from a major, unplanned amputation of the target limb through the 1-year visit in subjects who have CLI (RCC 4 - 6) at time of enrollment.
    Time Frame
    One Year
    Secondary Outcome Measure Information:
    Title
    Device Success (in All Patients Enrolled)
    Description
    Device success was defined as ≤ 30% residual stenosis following use of the SilverHawk device, as measured by angiography, without adjunctive endovascular interventions or periprocedural complications.
    Time Frame
    Immediately following use of the SilverHawk device
    Title
    Procedural Success (in All Patients Enrolled)
    Description
    Procedure success was defined as ≤ 30% residual stenosis following use of SilverHawk device and adjunctive endovascular interventions (if required) as measured by angiography without periprocedural complications.
    Time Frame
    Immediately following use of the SilverHawk and adjunctive devices
    Title
    Major Adverse Event Rate (in All Patients Enrolled)
    Description
    Major Adverse Event Rate (MAE) at 30 Days was defined as clinically-driven target vessel revascularization (TVR), major unplanned amputation of treated limb, or all-cause mortality within 30 days post procedure, as classified by the Clinical Events Committee (CEC).
    Time Frame
    30 Days
    Title
    Major Adverse Event Rate (in All Patients Enrolled)
    Description
    Major Adverse Event Rate at One Year was defined as clinically-driven target vessel revascularization, major unplanned amputation of the treated limb, or all-cause mortality within one year, as classified by the Clinical Events Committee (CEC).
    Time Frame
    One Year
    Title
    Improvement in Walking Impairment Questionnaire Score (in Patients Treated for Claudication RCC 1-3)
    Description
    WIQ includes a measurement for walking distance, walking speed, and climbing stairs collected at baseline and one year, presented for subjects who have claudication. The Walking Improvement Questionnaire (WIQ) is a validated method to assess objective improvement in functional walking ability of subjects with intermittent claudication. Difficulty walking a distance was self-assessed at baseline by the patient (prior to treatment) and at the one year follow up visit. Speed and stair climbing ability were assessed by the treating physician. Scale ranges from 0 (minimum) to 100 (maximum), with larger numbers representing better outcomes. An increase in WIQ scores at 1 year represents an improvement over baseline.
    Time Frame
    Baseline and 1 Year
    Title
    Improvement in Rutherford Clinical Category (in All Patients Enrolled)
    Description
    Change in RCC at One Year was assessed and percentage of subjects with an improvement in clinical status indicated by a decrease of one or more in RCC at one year compared to baseline, that is attributable to the treated limb (in cases of bilateral disease), was calculated.
    Time Frame
    1 Year
    Title
    Ankle-Brachial Index (in All Patients Enrolled)
    Description
    Change in Ankle-Brachial Index at One Year was calculated and percentage of subjects with an increase (improvement) in the ankle-brachial index (ABI) at one year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9 was calculated.
    Time Frame
    1 Year
    Title
    Secondary Patency (in Patients Treated for Claudication RCC 1-3)
    Description
    Secondary patency was defined as measured by duplex ultrasound peak systolic velocity ratio ≤ 3.5 maintained by repeat percutaneous intervention in subjects who have claudication; estimated as freedom from loss of patency by the Kaplan-Meier method at one year.
    Time Frame
    One Year
    Title
    Primary Patency (in Patients Treated for Critical Limb Ischemia RCC 4-6)
    Description
    The primary patency for CLI was defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who have CLI at time of enrollment
    Time Frame
    One Year
    Title
    Amputation-Free Survival (in Patients Treated for Claudication RCC 1-3)
    Description
    Amputation-Free Survival in Claudicants at One Year was defined as freedom from a major, unplanned amputation of the target limb through the one year visit in subjects who have claudication at time of enrollment.
    Time Frame
    One Year
    Title
    Improvement in Wound Healing (in Patients Treated for Critical Limb Ischemia and With Wounds RCC 5-6)
    Description
    Wound healing at three months was defined as a decrease of at least one Wagner Classification grade of the wound at three months compared to baseline in subjects who have Rutherford Clinical Category score of 5 or 6 at the time of enrollment.
    Time Frame
    3 months
    Title
    Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) at 1 Year (in Patients Treated for Claudication RCC 1-3)
    Description
    Defined by the duplex ultrasound measurement of peak systolic velocity ration ≤ 2.4 at the target lesion (s) with no clinically-driven re- intervention with the treated segment in subjects who have claudication at time of enrollment.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria Has a Rutherford Clinical Category Score of 1 - 6. Has evidence of ≥ 50% stenosis or occlusion in the superficial femoral, popliteal, anterior tibial, posterior tibial and/or peroneal arteries, confirmed by angiography. Has identifiable distal target vessel which upon completion of the intervention, is anticipated to provide re-constitution of blood flow to the foot. Exchangeable guidewire must cross lesion(s), with ability of catheter to cross lesion. Each discrete target lesion's length is ≤ 20 cm. Reference vessel diameter is ≥ 1.5 mm and ≤ 7 mm. Exclusion Criteria Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure. Has any planned surgical intervention or endovascular procedure within 30 days after the index procedure. Has had a previous peripheral bypass affecting the target limb. Has end-stage renal disease defined as undergoing hemodialysis for kidney failure. Has presence of severe calcification in target lesion(s). Has in-stent restenosis of the target lesion. Has an aneurysmal target vessel. Has significant stenosis or occlusion of inflow tract that has not been revascularized prior to treatment of the target vessel. Has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment. Has disease that precludes safe advancement of the SilverHawk/TurboHawk device to the target lesion(s). Has had a previous amputation above the metatarsal line on the target limb.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lawrence Garcia, MD
    Organizational Affiliation
    St. Elizabeth's Medical Center, Tuft's University School of Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    James McKinsey, MD
    Organizational Affiliation
    The New York Presbyterian/Columbia University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Professor Thomas Zeller
    Organizational Affiliation
    Herz-Zentrum Bad Krozingen Germany
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25147039
    Citation
    McKinsey JF, Zeller T, Rocha-Singh KJ, Jaff MR, Garcia LA; DEFINITIVE LE Investigators. Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study. JACC Cardiovasc Interv. 2014 Aug;7(8):923-33. doi: 10.1016/j.jcin.2014.05.006.
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    Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)

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