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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT00451256
Eligibility Criteria:
Inclusion Criteria:
* Subject is ≥ 18 years of age
* Subject is a suitable candidate for aortocoronary bypass (CABG) procedure. Subjects undergoing CABG procedure without the use of coronary artery bypass (off pump) are preferred. However, subjects requiring coronary artery bypass will not be excluded from the study
* Female subjects of childbearing potential must have a documented negative serum pregnancy test within 2 days before the CABG procedure
* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
* Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
Exclusion Criteria:
* Subject will have valve replacement or repair during CABG procedure
* Subject has a poor quality donor vessel (poor or turbulent flow, varicose)
* Subject has a known left ventricular ejection fraction of \<35%
* Subject has had a percutaneous coronary intervention (PCI) for coronary artery disease treatment 30 days prior to CABG
* Subject has a PCI planned during the 30 days immediately following the CABG procedure
* Subject has chronic atrial fibrillation
* Subject has a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, or sensitivity to contrast media which cannot be adequately pre-medicated
* Subject has chronic renal insufficiency (i.e., serum creatinine \>180 mmol/L) or co-morbid illness which precludes follow-up angiography
* Subject has history of a stroke or transient ischemic attack within the prior 6 months
* Subject has an active peptic ulcer or has had clinically significant upper or lower GI bleeding within the prior 6 months
* Subject has a history of a bleeding diathesis or coagulopathy or will refuse blood transfusions
* Subject has a non-cardiac illness imposing substantial operative mortality
* Subject has a concurrent medical condition resulting in a life expectancy of less than 3 years
* Subject is currently participating in an investigational drug or another device study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00451256
Study Brief:
Protocol Section:
NCT00451256