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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Heart / Stent
Title   A U.S. Post-Approval Study of the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System
Description   The purpose of this study is to collect more information on the PROMUS Element Plus stent system, details of the stent procedure, and information about the patients who are treated with this stent.
IRB Number   Pro3763
Inclusion/Notes   INCLUSION:
  • PLATINUM-like* patients.

  • Patients who are not PLATINUM-like.

  • Patients with ST elevation myocardial infarction (STEMI).

  • Patients with acute coronary syndrome/ unstable angina.

  • Elective patients treated with planned percutaneous coronary intervention (PCI).

  • Long lesions.

  • Multiple overlapping stents.

  • Bifurcation lesions.

  • Patients with medically treated diabetes.

  • Patients with renal insufficiency.

  • Patients with 2 or 3 vessels treated.

  • Left main (LM) lesions.

  • Patients with total occlusions (TO).

  • Stenting of aorto-coronary saphenous vein grafts.

  • Stenting post-brachytherapy.

  • ISR (BMS) lesions.

  • ISR (DES) lesions.

  • Patients with left ventricular dysfunction with ejection fraction (EF) < 25%.

  • Male Gender.

  • Female Gender.

  • Patients with a single 32 or 38mm (length) stent (with 2.5 to 4.0mm diameters).

  • Patients with multiple stents, including 32 or 38mm (length) stent(s) with 2.5 to 4.0mm diameters
    * “PLATINUM-like” is defined in section 9.1 of this Protocol.

EXCLUSION:
  • The PI will deem if subject is excluded from study as there are no specified exclusionary criteria.
Status   Active - not Recruiting
Location   Texas Health Presbyterian Hospital Dallas
Principal Name    James F Parker MD
Contact Name   Michelle Morgan
Phone   (214) 345-8308

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