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:
2025-12-25 @ 4:40 AM
Ignite Modification Date:
2025-12-25 @ 4:40 AM
NCT ID:
NCT00453518
Eligibility Criteria:
Inclusion Criteria:
* Candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting and emergent coronary artery bypass graft (CABG).
* Myocardial ischemia as evidenced by one or more of the following:
* Diagnosis of stable or unstable angina pectoris
* ECG changes consistent with ischemia
* Positive functional study
* Recent myocardial infarction
* Lesion(s) is located within SVG and is ≥ 50% and \< 100% stenosed.
Exclusion Criteria:
Clinical Criteria:
* Myocardial infarction with documented total CK-MB \> 2 times the upper limit of normal within the past 24 hours, or currently experiencing an acute myocardial infarction.
* Undergone cardiac surgery within the past 60 days.
* A planned invasive surgical procedure within 30 days.
* The lesion(s) is in an SVG that is less than 2 months post-implant.
* Left ventricular ejection fraction \< 20%.
* A stroke or transient ischemic neurological attack (TIA) within the past 2 months.
Angiographic Criteria:
* The lesion(s) is in an arterial conduit.
* Lesion is within 10 mm of the proximal anastomosis.
* More than two native lesions \[in addition to the SVG lesion(s)\] that need to be treated at the index procedure.
* More than two SVGs that need to be treated at the index procedure.
* Chronic total occlusion of a target lesion.
* The SVG lesion(s) requires treatment with a large device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, rheolytic thrombectomy or brachytherapy).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00453518
Study Brief:
Protocol Section:
NCT00453518