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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Heart / Stent
Title   Comparison of post-dilation and cryoplasty (Heart / Stent)
Description   In this study we propose to compare the expansion (post-dilation) of metal stents after their placement in diseased arteries using two methods. Post-dilation refers to the expansion of the stent (using a balloon). In one method a cold therapy using nitrous oxide balloon, called cryoplasty, will be used to post-dilate the stents. In the other method a conventional angioplasty balloon will be used to expand the nitinol stents.
IRB Number   Pro287
Inclusion/Notes   INCLUSION:
  • Diabetics, insulin or non-insulin dependent above 21 years of age.

  • Able to provide an informed consent.

  • Life expectancy > 1 year.

  • Presenting with severe intermittent claudication (Rutherford stage 3), chronic critical limb ischemia with pain while the patient was at rest (Rutherford stage 4), or chronic critical limb ischemia with ischemic ulcers (Rutherford stage 5).

  • Placement of > 5 mm in diameter self-expanding Nitinol stent in the SFA.

  • Placement of > 60 mm in length self-expanding Nitinol stent in the SFA.

EXCLUSION:
  • Serum creatinine of > 2.0 mg/dl.

  • Presence of iodinated contrast allergy.

  • Presence of allergy to Aspirin and Plavix.

  • Pregnancy.

  • Relative or absolute contraindication for anticoagulation.

  • History of allergy to unfractionated heparin or heparin induced
    thrombocytopenia (HIT).

  • White blood count < 3000; platelet count < 100000, and baseline
    hemoglobin < 10 g/dl.

  • Absence of brisk at least 1 vessel infra-poppliteal runoff to the foot.

  • Left ventricular ejection fraction < 25%.
Status   Completed
Location   Texas Health Presbyterian Hospital Dallas
Principal Name    Tony S Das MD
Contact Name   Jenny Collins
Phone   (214) 350-0869

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