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OpenTrials
Completed

NCT Number: NCT00733135

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

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device

Device

Catheter-based excision of moderate to severely calcified plaque located in the SFA and/or popliteal artery.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medtronic Endovascular

Industry

Registry information

Official study 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++)

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 12, 2008
Registry last updated
Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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