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

This study has been completed.
Information provided by (Responsible Party):
Medtronic - MITG Identifier:
First received: April 16, 2009
Last updated: May 3, 2013
Last verified: May 2013

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
Critical Limb Ischemia
Device: SilverHawk Peripheral Plaque Excision System
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 - MITG:

Primary Outcome Measures:
  • Primary Patency Rate (in patients treated for claudication) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Amputation-Free Survival at 1 Year (in patients treated for critical limb ischemia) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Device Success [ Time Frame: Procedural ] [ Designated as safety issue: No ]
  • Procedural Success [ Time Frame: Procedural ] [ Designated as safety issue: No ]
  • Major Adverse Event Rate [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • Major Adverse Event Rate [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
  • Improvement in Walking Impairment Questionnaire Score (in patients treated for claudication) [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Improvement in Rutherford Clinical Category [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Improvement in Ankle-Brachial Index [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Secondary Patency (in patients treated for claudication) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
  • Primary Patency (in patients with critical limb ischemia) [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Amputation-Free Survival (in patients with claudication) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
  • Wound healing (in patients with critical limb ischemia) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 800
Study Start Date: April 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: SilverHawk Peripheral Plaque Excision System
    Removal of atherosclerotic plaque from artery walls.
    Other Name: SilverHawk (Atherectomy), TurboHawk (Atherectomy)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00883246

Sponsors and Collaborators
Medtronic - MITG
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

No publications provided by Medtronic - MITG

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic - MITG Identifier: NCT00883246     History of Changes
Other Study ID Numbers: DEFINITIVE LE
Study First Received: April 16, 2009
Last Updated: May 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic - MITG:

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on October 06, 2015