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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Cardiology
Title   The Chocolate Balloon Angioplasty Registry, The Chocolate BAR (Cardiology)
Description   This is a registry to collect information from the commercial use of the Chocolate Balloon Catheter in the Percutaneous Transluminal Angioplasty (PTA) procedure which is done to clear blockages in the arteries (blood vessels) in the leg.
IRB Number   Pro3820
Inclusion/Notes   INCLUSION:
  • 18 years of age and older.

  • Lesion successfully crossed with a guide wire.

  • Reference Vessel Diameter (RVD) within the treatment range of the Chocolate PTA catheter used at the target lesion appropriate for 1:1 dilatation.

  • Angiographic evidence of Distal Run-off immediately prior the use of the Chocolate Balloon as follows:
    - Femoral-Popliteal Target Lesions: At least one patent tibial vessel without evidence of stenosis from origin to foot, OR
    - Below the Knee Target Lesions: Distal reconstitution of target vessel =/>2 cm proximal to the ankle joint.
  • Patient has given consent for their information to be submitted to this registry.

EXCLUSION:
  • Planned primary stenting of the target lesion.

  • Presence of a flow-limiting dissection at the target lesion prior to use of the Chocolate Balloon (secondary to the use of another device).

  • Patients with Rutherford 6.

  • Life expectancy <12 months.

  • Patient is enrolled in another clinical study that may impact the results of this registry.
Status   Recruiting
Location   Texas Health Presbyterian Hospital Dallas
Principal Name    Tony S Das MD
Contact Name   Sylvia Moore
Phone   (469) 916-7892

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