Clinical trial NCT05829889: Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease
Official title: A Comparison of Fractional Flow Reserve- Versus Angiography-Guided Percutaneous Coronary Intervention in Patients With Left Main Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease Left Main
Coronary Artery Disease
Keywords: Fractional Flow Reserve
Percutaneous Coronary Intervention
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2023-04-26
Enrollment: 934
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The composite event rate
timeFrame: 2 years
Secondary outcomes:
measure: The event rate of death from any causes
timeFrame: 2 years
measure: The event rate of myocardial infarction
timeFrame: 2 years
measure: The event rate of hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest
timeFrame: 2 years
measure: The event rate of repeat revascularization
timeFrame: 2 years
measure: The composite event rate of death or myocardial infarction
timeFrame: 2 years
measure: The event rate of stent thrombosis
timeFrame: 2 years
measure: The event rate of stroke
timeFrame: 2 years
measure: The event rate of bleeding complications
timeFrame: 2 years
measure: Procedure time
timeFrame: 1 day
measure: Amount of contrast agent used
timeFrame: 1 day
measure: Length of hospital stay
timeFrame: an average of 7 day
measure: The event rate of rehospitalization
timeFrame: 2 years
measure: Functional class
timeFrame: 7 days(discharge) and 1, 6, 12, 24 months
measure: Change of angina-related quality of life index
timeFrame: 7 days(discharge) and 1, 6, 12, 24 months
measure: Change of health-related quality of life index
timeFrame: 7 days(discharge) and 1, 6, 12, 24 months
measure: Number of anti-anginal medications
timeFrame: 7 days(discharge) and 1, 6, 12, 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Bucheon
country: Korea, Republic of
facility: Bucheon Sejong Hospital
Study officials:
affiliation: Asan Medical Center
name: Duk-woo Park, MD
role: PRINCIPAL_INVESTIGATOR
References: