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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Heart / Stent
Title   Study to better understand the safety and efficacy of 12 months versus 30 months of Dual Anti-Platelet Therapy (DAPT) in subjects who undergo stenting procedures (Heart/Stent)
Description   The aim of this study is to conduct a prospective, multicenter trial to contribute data to a critical path initiative (CPI) to better understand the safety and efficacy of 12 months versus 30 months of Dual Anti-Platelet Therapy (DAPT) in subjects who undergo stenting procedures.
IRB Number   Pro2115
Inclusion/Notes   INCLUSION:
  • Patient is > 18 years of age.

  • The patient or patient’s legal representative has consented to participate and has authorized the collection and release of his medical information by signing the “Subject Informed Consent Form”.

  • Patients undergoing percutaneous intervention with Endeavor stent deployment (or has within 24 hours).

  • The patient is willing and able to cooperate with study procedures and required follow up visits.

  • Patient is able to read, write and understand English.

EXCLUSION:
  • Index procedure stent placement with stent diameter < 2.5 mm or > 3.5 mm.

  • Pregnant women.

  • Current medical condition with a life expectancy of less than 3 years.

  • The patient is currently participating in another investigational device or drug study that clinically interferes with EDUCATE. The patient may only be enrolled in EDUCATE once.

  • Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use.

  • Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.

  • Patients treated with any stent other than the Endeavor stent during the index procedure.
Status   Active - not Recruiting
Location   Texas Health Harris Methodist Hospital Fort Worth
Principal Name    Gurpreet Singh Baweja MD
Contact Name   Anne Gilbert
Phone   (817) 820-4964

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