Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE) - Full Text View

Sponsor:	ev3
Information provided by:	ev3
ClinicalTrials.gov Identifier:	NCT00883246

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 IV

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:

MedlinePlus related topics: Peripheral Arterial Disease

U.S. FDA Resources

Further study details as provided by ev3:

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 ]

Estimated Enrollment:	800
Study Start Date:	April 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Removal of atherosclerotic plaque from artery walls.

Other Name: SilverHawk (Atherectomy), TurboHawk (Atherectomy)

Eligibility

Ages Eligible for Study:	18 Years and older
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883246

Sponsors and Collaborators

ev3

Investigators

Principal Investigator:	Lawrence Garcia, MD	St. Elizabeth's Medical Center
Principal Investigator:	James McKinsey, MD	The New York Presbyterian/Columbia University

More Information

No publications provided

Responsible Party:	Christina Drager, Clinical Study Manager, ev3 Inc.
ClinicalTrials.gov Identifier:	NCT00883246 History of Changes
Other Study ID Numbers:	DEFINITIVE LE
Study First Received:	April 16, 2009
Last Updated:	April 11, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by ev3:

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 February 09, 2012