In This SectionTexas 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.
