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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT00817102
Eligibility Criteria:
Inclusion Criteria:
* Age 21-85
* Presence of at least one obstructive coronary artery stenosis as defined by:
* Previous catheterization or CT angiogram with any lesion 70% or greater
* Previous positive functional stress test (this does not include CTA alone)
* Ability and Willingness to provide informed consent
* Ability and Willingness to perform required follow up procedures
Exclusion Criteria:
* History of coronary artery bypass graft surgery
* Previously revascularized lesion
* Creatinine\>1.6 mg/dL or GFR\<30 pre-procedure per institutional standards
* Known Pregnancy
* Inability to perform CTA
* Arrhythmia precluding diagnostic CT examination
* Contrast agent allergy that cannot be adequately premedicated
* Severe PVD precluding cardiac catheterization
* Patient not a candidate for IVUS and FFR
* Inability or unwillingness to provide informed consent
* Inability or unwillingness to perform required follow up procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT00817102
Study Brief:
Protocol Section:
NCT00817102