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

Coronary Artery Disease Clinical Trial

— FATE-MAIN  

Official title:

A Comparison of Fractional Flow Reserve- Versus Angiography-Guided Percutaneous Coronary Intervention in Patients With Left Main Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05829889
• Other study ID #: AMCCV2023-02
• Status: Recruiting
• Phase: Phase 4
• Start date: April 25, 2024
• Est. completion date: December 2027

Study information

• Verified date: June 2024
• Source: Asan Medical Center
• Contact: Duk-woo Park, MD
• Email: dwpark[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 934
• Est. completion date: December 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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. Extremely calcified or tortuous vessels precluding FFR measurement.

2. 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).

3. Recent ST Elevation Myocardial Infarction(<7 days prior to randomization).

4. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.

5. Severe left ventricular dysfunction (ejection fraction <30%).

6. Requirement for other cardiac surgical procedure (e.g., valve replacement or aorta surgery).

7. Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or clopidogrel).

8. Prior PCI of the left main trunk.

9. Prior coronary artery bypass graft surgery.

10. Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year.

11. End-stage renal disease requiring renal replacement therapy.

12. Liver cirrhosis.

13. Pregnant and/or lactating women.

14. Concurrent medical condition with a limited life expectancy of less than 2 years.

15. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease Left Main
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• FFR-Guided PCI
Fractional Flow Reserve-Guided PCI
• Angiography-Guided PCI
Angiography-Guided PCI

Locations

Country	Name	City	State
Korea, Republic of	Bucheon Sejong Hospital	Bucheon
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite event rate	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.	2 years
Secondary	The event rate of death from any causes		2 years
Secondary	The event rate of myocardial infarction	any, spontaneous or procedural myocardial infarction	2 years
Secondary	The event rate of hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest		2 years
Secondary	The event rate of repeat revascularization		2 years
Secondary	The composite event rate of death or myocardial infarction		2 years
Secondary	The event rate of stent thrombosis	Stent thrombosis by Academic Research Consortium (ARC) definition	2 years
Secondary	The event rate of stroke		2 years
Secondary	The event rate of bleeding complications	Bleeding Academic Research Consortium [BARC] type 3-5, which indicates severe bleeding	2 years
Secondary	Procedure time		1 day
Secondary	Amount of contrast agent used		1 day
Secondary	Length of hospital stay		an average of 7 day
Secondary	The event rate of rehospitalization	Rehospitalization from any, cardiac, or noncardiac causes	2 years
Secondary	Functional class	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.	7 days(discharge) and 1, 6, 12, 24 months
Secondary	Change of angina-related quality of life index	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.	7 days(discharge) and 1, 6, 12, 24 months
Secondary	Change of health-related quality of life index	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.	7 days(discharge) and 1, 6, 12, 24 months
Secondary	Number of anti-anginal medications		7 days(discharge) and 1, 6, 12, 24 months