EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:19 - Any
Updated:4/21/2016
Start Date:April 2010
End Date:April 2014

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EDUCATE: a Prospective, Multi-center Study Designed to Collect Real-world Safety and Clinical Outcomes in Subjects Receiving One or More Endeavor Zotarolimus-Eluting Stents and Either Clopidogrel and Aspirin or Prasugrel and Aspirin as Part of a Dual Antiplatelet Therapy (DAPT) Drug Regimen

EDUCATE is a prospective, multi-center study designed to collect real-world safety and
clinical outcomes in subjects receiving one or more Endeavor Zotarolimus-Eluting Stents and
either clopidogrel and aspirin or prasugrel and aspirin as part of a dual antiplatelet
therapy (DAPT) drug regimen.

To provide clinical information on rates of late and very late stent thrombosis after
Endeavor Drug-eluting Stent (DES)placement in an all comers population with a broad range of
bleeding and thrombosis risk. EDUCATE will further analyze the current practice of
clinicians regarding temporary cessation of antiplatelet therapy and its association with
clinical outcomes. In addition, patients included in this broad Endeavor registry will also
be contributed to the DAPT native study population for analysis of 12 vs 30 months duration
of dual antiplatelet therapy.

ENROLLMENT INCLUSION CRITERIA

- Patient is older than 18 years.

- 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.

ENROLLMENT EXCLUSION CRITERIA

- 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 the EDUCATE Study. The patient may only be
enrolled in the EDUCATE Study once.

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

- Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.

- Patients treated with any stent other than the Endeavor stent during the index
procedure.

RANDOMIZATION INCLUSION CRITERIA AT 12 MONTHS

- Subject is "12 Month Clear".

- Subjects without known contraindication to dual antiplatelet therapy for at least 18
months after randomization.

RANDOMIZATION EXCLUSION CRITERIA AT 12 MONTHS

- Pregnant women.

- Subject switched thienopyridine type or dose within 6 months prior to randomization.

- Planned surgery necessitating discontinuation of antiplatelet therapy within the 18
months following randomization.

- Percutaneous coronary intervention or cardiac surgery between 6 weeks post index
procedure and randomization.

- Planned surgery necessitating discontinuation of antiplatelet therapy within the 21
months following randomization.

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

- Subjects on warfarin or similar anticoagulant therapy.
We found this trial at
1
site
Anderson, South Carolina 29621
?
mi
from
Anderson, SC
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