Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT01069003
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT01069003
Study Brief:
Protocol Section:
NCT01069003