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 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT05491668
Eligibility Criteria:
Inclusion Criteria:
* Age \>/= 18 years
* Patient provides written informed consent
* Clinical presentation with stable coronary artery disease or acute coronary syndromes (unstable angina, Non-ST Elevation Myocardial Infarction (NSTEMI), or ST Elevation Myocardial Infarction (STEMI))
* Scheduled for clinically indicated cardiac catheterization
* At least one lesion with angiographic severity visually estimated to be \>/= 70% diameter stenosis that is deemed suitable for PCI
* The operator plans to perform PCI on an ad hoc or planned basis
* The target lesion is not planned for assessment by invasive physiology
Exclusion Criteria:
* Failure to provide signed informed consent
* Culprit vessel of acute ST Elevation Myocardial Infarction (STEMI)
* Culprit vessel of Non-ST Elevation Myocardial Infarction (NSTEMI)
* Thrombolysis In Myocardial Infarction (TIMI) flow less than grade 3 at baseline or visible thrombus
* Chronic total occlusion (CTO) in the target vessel
* Target vessel is supplied by major collaterals or supplies major collaterals to a CTO
* Target lesion involves the left main coronary artery
* Prior history of coronary artery bypass grafting (CABG) to the target vessel, except if bypass graft is occluded
* Previously known untreated severe valvular heart disease
* Previously known left ventricular ejection fraction \<30%
* Sustained ventricular arrhythmias
* Patients who are currently pregnant (pregnancy testing will be performed as per standard cardiac catheterization laboratory protocol)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05491668
Study Brief:
Protocol Section:
NCT05491668