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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
960
Fractional Flow Reserve-Guided PCI
Angiography-Guided PCI
Princess Margret Hospital( HongKong)
Hong Kong, Hong Kong
NOT_YET_RECRUITINGQueen Mary Hospital
Hong Kong, Hong Kong
NOT_YET_RECRUITINGManipal Hospital
Bangalore, India
RECRUITINGJapanese Red Cross Musashino Hospital
Tokyo, Japan
NOT_YET_RECRUITINGThe 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.
Time frame: 2 years
The event rate of death from any causes
Time frame: 2 years
The event rate of myocardial infarction
any, spontaneous or procedural myocardial infarction
Time frame: 2 years
The event rate of hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest
Time frame: 2 years
The event rate of repeat revascularization
Time frame: 2 years
The composite event rate of death or myocardial infarction
Time frame: 2 years
The event rate of stent thrombosis
Stent thrombosis by Academic Research Consortium (ARC) definition
Time frame: 2 years
The event rate of stroke
Time frame: 2 years
The event rate of bleeding complications
Bleeding Academic Research Consortium \[BARC\] type 3-5, which indicates severe bleeding
Time frame: 2 years
Procedure time
Time frame: 1 day
Amount of contrast agent used
Time frame: 1 day
Length of hospital stay
Time frame: an average of 7 day
The event rate of rehospitalization
Rehospitalization from any, cardiac, or noncardiac causes
Time frame: 2 years
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.
Time frame: 7 days(discharge) and 1, 6, 12, 24 months
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.
Time frame: 7 days(discharge) and 1, 6, 12, 24 months
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.
Time frame: 7 days(discharge) and 1, 6, 12, 24 months
Number of anti-anginal medications
Time frame: 7 days(discharge) and 1, 6, 12, 24 months
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NTT East Japan Kanto Hospital
Tokyo, Japan
NOT_YET_RECRUITINGTsuchiura Kyodo General Hospital
Tsuchiura, Japan
RECRUITINGAsan Medical Center
Seoul, Songpa-gu, South Korea
RECRUITINGKorea University Ansan Hospital
Ansan, South Korea
NOT_YET_RECRUITINGHallym University Sacred Heart Hospital
Anyang, South Korea
RECRUITINGBucheon Sejong Hospital
Bucheon-si, South Korea
RECRUITING...and 38 more locations