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Study of the SilverHawk/TurboHawk Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)

This study has been completed.
Sponsor:
Information provided by:
ev3
ClinicalTrials.gov Identifier:
NCT00733135
First received: August 8, 2008
Last updated: November 19, 2010
Last verified: November 2010
History of Changes
  Purpose

This is a multi-center, non-randomized, single arm study of the SilverHawk/TurboHawk plaque excision systems when used in conjunction with SpiderFX in treatment of moderate to severely calcified peripheral arterial disease in the superficial femoral and/or popliteal arteries.


Condition Intervention Phase
Peripheral Arterial Disease
 Device: SilverHawk® LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C and SpiderFX™
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Determination of Safety and Effectiveness of the SilverHawk® Peripheral Plaque Excision System for Calcium (SilverHawk LS-C) and the SpiderFX Embolic™ Protection Device (SpiderFX) for the Treatment of Calcified Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries (DEFINITIVE Ca++)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ev3:

Primary Outcome Measures:
  • Successful revascularization [ Time Frame: procedural ] [ Designated as safety issue: No ]
  • Major Adverse Events [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Technical procedural success [ Time Frame: procedural ] [ Designated as safety issue: Yes ]
  • Residual diameter stenosis [ Time Frame: procedural ] [ Designated as safety issue: No ]
  • Capture of debris [ Time Frame: procedural ] [ Designated as safety issue: No ]
  • Preservation of run-off [ Time Frame: procedural ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 133
Study Start Date: October 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: SilverHawk® LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C and SpiderFX™
    Catheter-based excision of moderate to severely calcified plaque located in the SFA and/or popliteal artery.
    Other Names:
    • SilverHawk LS-C
    • RockHawk
    • TurboHawk
    • SpiderFX
    • Leg pain
    • Claudication
  Eligibility

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

Inclusion Criteria:

  • Provides written informed consent
  • Willing to comply with follow-up evaluations at specified times
  • Has leg pain due to peripheral arterial disease
  • Disease located within the femoropopliteal artery
  • Moderate to severe calcification

Exclusion Criteria:

  • Previously implanted stent(s) or stent graft(s) in target leg
  • Life expectancy less than 12 months
  • Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733135

Locations
United States, California
Good Samaritan Hospital
Los Angeles, California, United States, 90017
Sacramento Heart and Vascular Research Center
Sacramento, California, United States, 95825
United States, Colorado
Medical Center of the Rockies Foundation
Loveland, Colorado, United States, 80538
United States, Florida
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
United States, Georgia
Emory University Hospital - Midtown
Atlanta, Georgia, United States, 30308
Rockdale Medical Center
Conyers, Georgia, United States, 30012
United States, Indiana
The Heart Center of Lake County
Merrillville, Indiana, United States, 46410
United States, Iowa
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States, 52803
United States, Kansas
Promise Regional Medical Center
Hutchinson, Kansas, United States, 67502
United States, Michigan
Harper University Hospital
Detroit, Michigan, United States, 48201
St. John Hospital
Detroit, Michigan, United States, 48236
United States, Minnesota
Metropolitan Cardiology
Minneapolis, Minnesota, United States, 55433
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, Ohio
The Christ Hospital/ Health Alliance/ Lindner Clinical Trials Center
Cincinnati, Ohio, United States, 45219
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Tennessee
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Parkwest Hospital
Knoxville, Tennessee, United States, 37923
United States, Texas
Austin Heart P.A.
Austin, Texas, United States, 78756
Sponsors and Collaborators
ev3
Investigators
Principal Investigator: Daniel Clair, MD The Cleveland Clinic
Principal Investigator: David Roberts, MD Sutter Medical Center
  More Information

No publications provided

Responsible Party: ev3, Study Sponsor, ev3
ClinicalTrials.gov Identifier: NCT00733135     History of Changes
Other Study ID Numbers: FHT-P-07-003
Study First Received: August 8, 2008
Last Updated: November 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by ev3:
peripheral vascular disease
atherectomy
atherosclerosis
calcified lesions

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

ClinicalTrials.gov processed this record on May 23, 2013