FFR-guided PCI
ProcedureFractional Flow Reserve-Guided PCI
NCT Number: NCT05829889
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).
Interested in participating?
Request Info20 year and older
All sexes
Interventional
Not applicable
Princess Margret Hospital( HongKong), Hong Kong
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fractional Flow Reserve-Guided PCI
Angiography-Guided PCI
Time frame: 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.
Time frame: 2 years
Time frame: 2 years
any, spontaneous or procedural myocardial infarction
Time frame: 2 years
Time frame: 2 years
Time frame: 2 years
Time frame: 2 years
Stent thrombosis by Academic Research Consortium (ARC) definition
Time frame: 2 years
Time frame: 2 years
Bleeding Academic Research Consortium [BARC] type 3-5, which indicates severe bleeding
Time frame: 1 day
Time frame: 1 day
Time frame: an average of 7 day
Time frame: 2 years
Rehospitalization from any, cardiac, or noncardiac causes
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 7 days(discharge) and 1, 6, 12, 24 months
Contact information is provided by the study sponsor or research team.
Seung-Jung Park
Other
A Comparison of Fractional Flow Reserve- Versus Angiography-Guided Percutaneous Coronary Intervention in Patients With Left Main Coronary Artery Disease
Acronym: FATE-MAIN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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