A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Ar… (NCT02100722) | Clinical Trial Compass
CompletedNot Applicable
A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
United States, Australia, Belgium1,500 participantsStarted 2014-08-25
Plain-language summary
The purpose of this study is to determine whether Fractional flow reserve (FFR, (coronary pressure wire-based index for assessing the ischemic potential of a coronary lesion)-guided percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease (CAD) will result in similar outcomes to coronary artery bypass graft surgery (CABG).
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* 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 for 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.