Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease Left Main; Coronary Artery Disease
• Interventions: Procedure: Angiography-Guided PCI; Procedure: FFR-Guided PCI

• Registration Number: NCT05829889
• Lead Sponsor: Seung-Jung Park

Brief Summary

The primary purpose of the study was to determine whether the 2-year probability of major adverse cardiac events (primary composite outcome) differed significantly between patients who underwent angiography-guided Percutaneous Coronary Intervention(PCI) and those who underwent Fractional Flow Reserve(FFR)-guided PCI in patients with Left Main Coronary Artery disease(LMCA).

Detailed Description

All participants will be monitored over a span of two years and the time point of the year of last subject last visit. The term "year of last subject last visit" refers to the time point of the last visit for all participants. At this specific time point, event occurrence check will be conducted to determine the occurrence of endpoint events among all participants.

Study Timeline

• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-04-13
• Study First Posted: 2023-04-26
• Study Start: 2024-04-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2027-06
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 934

Inclusion Criteria

1. The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
2. Significant de novo LMCA disease, defined as ≥ 50% diameter stenosis by visual estimation with or without concomitant non-left main major epicardial coronary artery disease, amenable to PCI with drug-eluting stent(DES) implantation.
3. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria

1. left anterior descending coronary artery (LAD) or left circumflex coronary artery (LCx) chronic total occlusion (CTO)
2. Extremely calcified or tortuous vessels precluding FFR measurement.
3. The presence of complex coronary disease anatomy or lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that PCI is not suitable (i.e. the subject should be managed with coronary artery bypass graft or medical therapy alone).
4. Recent ST Elevation Myocardial Infarction(<7 days prior to randomization).
5. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
6. Severe left ventricular dysfunction (ejection fraction <30%).
7. Requirement for other cardiac surgical procedure (e.g., valve replacement or aorta surgery).
8. Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or clopidogrel).
9. Prior PCI of the left main trunk.
10. Prior coronary artery bypass graft surgery.
11. Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year.
12. End-stage renal disease requiring renal replacement therapy.
13. Liver cirrhosis.
14. Pregnant and/or lactating women.
15. Concurrent medical condition with a limited life expectancy of less than 2 years.
16. Subjects who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion;

1. Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial.

2. Screening failed before any interventional factor is involved.

3. Participated in academic trials like strategic comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Angiography-Guided PCI	Angiography-Guided PCI	-
FFR-guided Left Main PCI	FFR-Guided PCI	-

Primary Outcome Measures

Name	Time	Method
The composite event rate	2 years	Composite event consists of death from any causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, or repeat revascularization.; A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.

Secondary Outcome Measures

Name	Time	Method
The event rate of repeat revascularization	2 years
Functional class	7 days(discharge) and 1, 6, 12, 24 months	Functional class assessed by the Canadian Cardiovascular Society (CCS) Angina Score classification.; The minimum and maximum values are I and IV respectively and a higher score means a worse outcome.
The event rate of hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest	2 years
The event rate of stent thrombosis	2 years	Stent thrombosis by Academic Research Consortium (ARC) definition
Change of health-related quality of life index	7 days(discharge) and 1, 6, 12, 24 months	By the EQ-5D.; EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group. Range 0 - 1 and a higher score of EQ-5D mean low quality of life.
The event rate of death from any causes	2 years
The event rate of stroke	2 years
Procedure time	1 day
Length of hospital stay	an average of 7 day
Change of angina-related quality of life index	7 days(discharge) and 1, 6, 12, 24 months	By the Seattle Angina Questionnaire \[SAQ\].; the SAQ is a disease-specific patient-reported outcome (PRO) with 5 domains. Lower score represents poor health status and high score represents good health status.
Number of anti-anginal medications	7 days(discharge) and 1, 6, 12, 24 months
The event rate of myocardial infarction	2 years	any, spontaneous or procedural myocardial infarction
The composite event rate of death or myocardial infarction	2 years
The event rate of bleeding complications	2 years	Bleeding Academic Research Consortium \[BARC\] type 3-5, which indicates severe bleeding
The event rate of rehospitalization	2 years	Rehospitalization from any, cardiac, or noncardiac causes
Amount of contrast agent used	1 day

Trial Locations

Locations (2)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of

Bucheon Sejong Hospital; 🇰🇷 Bucheon, Korea, Republic of