Study of SilverHawk in Lower Extremity Vessels (DEFINITIVE LE) - Full Text View

Sponsored by:	ev3 Endovascular, Inc.
Information provided by:	ev3 Endovascular, Inc.
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® (Atherectomy)	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Determination of Effectiveness of SilverHawk Peripheral Plaque Excision (SilverHawk Device) for the Treatment of Infrainguinal Vessels/Lower Extremities

Further study details as provided by ev3 Endovascular, Inc.:

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 ]
Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) [ 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 ]

Estimated Enrollment:	800
Study Start Date:	May 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Removal of atherosclerotic plaque from artery walls.

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 confirmed by angiography.
Has evidence of at least one patent tibial segment, which, upon completion of the intervention, provides re-constitution 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 vessel.
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 device to the target lesion(s).

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

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

Keywords provided by ev3 Endovascular, Inc.:

PAD

Study placed in the following topic categories:

Peripheral Vascular Diseases
Vascular Diseases
Ischemia

Additional relevant MeSH terms:

Pathologic Processes
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia

ClinicalTrials.gov processed this record on May 06, 2009