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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT01132456
Eligibility Criteria:
Inclusion Criteria:
* Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
* Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
* Informed consent
* Patient agrees to comply with specified follow-up evaluations at same investigational site
* Single target lesion or two target lesions located in separate coronary arteries
* De novo lesion(s) in native coronary artery(ies)
* Target lesion(s) ≤ 35 mm in length (or both lesion lengths ≤ 27 mm for two lesions in separate target vessels to be considered for the dual vessel cohort)
* Target vessel(s) have reference vessel diameter 2.25 mm to 4.0 mm, (or 3.0 to 4.0 mm for it to be treated with a 38 mm length stent)
Exclusion Criteria:
* Within 7 days of implant platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; WBC count \<3,000 cells/mm³; serum creatinine level \>2.5 mg/dl
* Acute MI within 72 hrs of the index procedure (QWMI or any elevation of CK-MB \> lab upper limit of normal)
* Previous PCI of target vessel(s) within 9 months prior to the procedure
* Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
* History of stroke or TIA within prior 6 months
* Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
* Inability to comply with required trial antiplatelet regimen
* Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
* Target vessel(s) has/have other lesions w/ \> 40% diameter stenosis
* Unprotected left main coronary artery disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01132456
Study Brief:
Protocol Section:
NCT01132456