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 (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT00733135
First received: August 8, 2008
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

This is a multi-center, non-randomized, single arm study of the SilverHawk™ /TurboHawk™ plaque excision systems when used in conjunction with SpiderFX™ embolic protection device 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 plaque excision systems and SpiderFX™ embolic protection device
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 for the Treatment of Calcified Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries (DEFINITIVE Ca++)

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Successful Revascularization [ Time Frame: procedural ] [ Designated as safety issue: No ]
    Less than or equal to 50% residual diameter stenosis following plaque excision remaining at the target lesion(s), as adjudicated by the angiographic core laboratory

  • Major Adverse Event Free Rate 30 Days [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Technical Procedural Success [ Time Frame: procedural ] [ Designated as safety issue: Yes ]

    Technical Procedural Success was defined as meeting all of the following requirements:

    • Less than or equal to 50% residual diameter stenosis at the target lesion(s), as adjudicated by the angiographic core laboratory
    • No procedure-related Major Adverse Events (MAE), as adjudicated by the Clinical Events Committee (CEC)
    • No device malfunction causing the procedure to be aborted
    • Successful delivery and placement of the SpiderFX™ embolic protection device

  • Residual Diameter Stenosis [ Time Frame: procedural ] [ Designated as safety issue: No ]
    This endpoint was met when there was less than 30% residual diameter stenosis following treatment with SilverHawk™ /TurboHawk™ plaque excision systems and any adjunctive therapy (if required), as adjudicated by the angiographic core laboratory.

  • Presence of Debris in Deployed SpiderFx™ Embolic Protection Device [ Time Frame: procedural ] [ Designated as safety issue: No ]
    Presence of debris in deployed SpiderFx™ embolic protection device

  • Preservation of Run-off Distal to the Filter [ Time Frame: procedural ] [ Designated as safety issue: Yes ]
    Preservation of run-off distal to SpiderFX™ distal embolic protection device was determined by angiography of run-off vessels at the end of the procedure, as adjudicated by the angiographic core laboratory.


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 plaque excision systems and SpiderFX™ embolic protection device
    Catheter-based excision of moderate to severely calcified plaque located in the SFA and/or popliteal artery.
  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
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: NCT00733135

Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Daniel Clair, MD The Cleveland Clinic
Principal Investigator: David Roberts, MD Sutter Medical Center
  More Information

Publications:
Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT00733135     History of Changes
Other Study ID Numbers: FHT-P-07-003
Study First Received: August 8, 2008
Results First Received: June 5, 2014
Last Updated: July 24, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014