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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07308860
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 21 years with angina and/or evidence of myocardial ischemia
2. Three vessel CAD, defined as ≥ 50% diameter stenosis by visual estimation in each of the three major epicardial vessels or major side branches, but not involving left main coronary artery, and amenable to revascularization by both PCI and CABG as determined by the Heart Team. Patients with a non-dominant right coronary artery may be included if only the left anterior descending artery (LAD) and left circumflex have
≥50% stenosis
3. Willing and able to provide informed, written consent
Exclusion Criteria:
1. Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, carotid revascularization), however a maze procedure or pulmonary vein isolation is allowed
2. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
3. Recent STEMI (\<5 days prior to randomization)
4. Ongoing Non STEMI with biomarkers (cardiac troponin) still rising
5. Known left ventricular ejection fraction \<30%
6. Life expectancy \< 2 years
7. Requiring renal replacement therapy
8. Undergoing evaluation for organ transplantation
9. Participation or planned participation in another clinical trial, except for observational registries
10. Pregnancy
11. Inability to take dual antiplatelet therapy or anticoagulation and single antiplatelet therapy for at least six months
12. Previous CABG
13. Left main disease requiring revascularization
14. Extremely calcified or tortuous vessels precluding FFR measurement
15. Any target lesion with in-stent drug-eluting stent restenosis
16. More than one major epicardial vessel which is chronically occluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT07308860
Study Brief:
Protocol Section:
NCT07308860