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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00883246
First received: April 16, 2009
Last updated: January 28, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention Phase
Peripheral Arterial Disease
Claudication
Critical Limb Ischemia
Device: SilverHawk Peripheral Plaque Excision System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Determination of Effectiveness of SilverHawk Peripheral Plaque Excision (SilverHawk Device) for the Treatment of Infrainguinal Vessels/Lower Extremities

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Primary Patency Rate (in Patients Treated for Claudication RCC 1-3) [ Time Frame: One year ] [ Designated as safety issue: No ]
    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) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Immediately following use of the SilverHawk device ] [ Designated as safety issue: No ]
    Device success was defined as ≤ 30% residual stenosis following use of the SilverHawk device, as measured by angiography, without adjunctive endovascular interventions.

  • Procedural Success (in All Patients Enrolled) [ Time Frame: Immediately following use of the SilverHawk and adjunctive devices ] [ Designated as safety issue: No ]
    Procedure success was defined as ≤ 30% residual stenosis following use of SilverHawk device and adjunctive endovascular interventions (if required) as measured by angiography

  • Major Adverse Event Rate (in All Patients Enrolled) [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    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).

  • Walking Impairment Questionnaire Score (in Patients Treated for Claudication RCC 1-3) [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
    WIQ Walking Distance Scores at Baseline and One Year are 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. 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.

  • Rutherford Clinical Category (in All Patients Enrolled) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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) [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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) [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    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.

  • Wound Healing (in Patients Treated for Critical Limb Ischemia and With Wounds RCC 5-6) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 800
Study Start Date: April 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Atherectomy
All patients enrolled in this single-arm study were treated with directional atherectomy.
Device: SilverHawk Peripheral Plaque Excision System
Removal of atherosclerotic plaque from artery walls.
Other Name: SilverHawk (Atherectomy), TurboHawk (Atherectomy)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • Has end-stage renal disease defined as undergoing hemodialysis for kidney failure.
  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: NCT00883246

Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Lawrence Garcia, MD St. Elizabeth's Medical Center, Tuft's University School of Medicine
Principal Investigator: James McKinsey, MD The New York Presbyterian/Columbia University
Principal Investigator: Professor Thomas Zeller Herz-Zentrum Bad Krozingen Germany
  More Information

Publications:
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00883246     History of Changes
Other Study ID Numbers: DEFINITIVE LE 
Study First Received: April 16, 2009
Results First Received: January 23, 2015
Last Updated: January 28, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Endovascular:
PAD

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

ClinicalTrials.gov processed this record on July 27, 2016