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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Heart / Peripheral Artery Disease
Title   Determination of effectiveness of a system for the removal of plaque buildup in the leg arteries (Heart / Peripheral Artery Disease)
Description   This is a data collection study for patients being treated with the SILVERHAWK and TURBOHAWK Peripheral Excision Systems for the removal of plaque buildup in the leg arteries.
IRB Number   Pro1789
Inclusion/Notes   INCLUSION:
  • Is willing and capable of complying with all follow-up evaluations at the specified times.

  • Is = 18 years old.
    Provides written informed consent prior to study specific procedures.

EXCLUSION:
  • Has one or more of the contraindications listed in the SilverHawk IFU.

  • Has a contraindication or known untreated allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug anticipated to be used.

  • Has a hypersensitivity to contrast material that cannot be adequately pretreated.

  • Has known hypersensitivity to treatment device material.

  • Has life expectancy of less than 12 months.
Status   Completed
Location   Texas Health Presbyterian Hospital Dallas
Principal Name    James Byung R. Park MD
Contact Name   Shelley Long
Phone   (214) 345-8131

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