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

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ClinicalTrials.gov Identifier: NCT00733135
Recruitment Status : Completed
First Posted : August 12, 2008
Results First Posted : July 4, 2014
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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++)
Study Start Date : October 2008
Primary Completion Date : November 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Atherectomy with embolic protection
All subjects were treated with atherectomy (with SilverHawk or TurboHawk device) in conjunction with embolic protection (SpiderFX device).
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.


Outcome Measures

Primary Outcome Measures :
  1. Successful Revascularization [ Time Frame: at the end of the procedure ]
    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

  2. Major Adverse Event Free Rate 30 Days [ Time Frame: 30 Days ]
    MAE was defined as a serious adverse event that results in death, acute myocardial infarction, dissection (grade C or greater), clinical perforation, pseudo-aneurysm, thrombosis, distal embolism (clinically relevant), amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC).


Secondary Outcome Measures :
  1. Technical Procedural Success [ Time Frame: at the end of the procedure ]

    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

  2. Residual Diameter Stenosis [ Time Frame: at the end of the procedure ]
    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.

  3. Presence of Debris in Deployed SpiderFx™ Embolic Protection Device [ Time Frame: at the end of the procedure ]
    Presence of debris in deployed SpiderFx™ embolic protection device

  4. Preservation of Run-off Distal to the Filter [ Time Frame: at the end of the procedure ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733135


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

Publications:
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00733135     History of Changes
Other Study ID Numbers: FHT-P-07-003
First Posted: August 12, 2008    Key Record Dates
Results First Posted: July 4, 2014
Last Update Posted: August 26, 2015
Last Verified: August 2015

Keywords provided by Medtronic Endovascular:
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