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

Overview

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.

Interventions

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

Primary outcome measures

• The composite event rate [Time frame: 2 years]

Secondary outcome measures (12)

• The event rate of death from any causes [Time frame: 2 years]
• The event rate of 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 [Time frame: 2 years]
• The event rate of stroke [Time frame: 2 years]
• The event rate of bleeding complications [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 [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

• The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
• 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.
• 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

• left anterior descending coronary artery (LAD) or left circumflex coronary artery (LCx) chronic total occlusion (CTO)
• Extremely calcified or tortuous vessels precluding FFR measurement.
• 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).
• Recent ST Elevation Myocardial Infarction(<7 days prior to randomization).
• Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
• Severe left ventricular dysfunction (ejection fraction <30%).
• Requirement for other cardiac surgical procedure (e.g., valve replacement or aorta surgery).
• Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or clopidogrel).
• Prior PCI of the left main trunk.
• Prior coronary artery bypass graft surgery.
• Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year.
• End-stage renal disease requiring renal replacement therapy.
• Liver cirrhosis.
• Pregnant and/or lactating women.
• Concurrent medical condition with a limited life expectancy of less than 2 years.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

South Korea · 42 centers

• Asan Medical Center — Seoul
• Korea University Ansan Hospital — Ansan
• Hallym University Sacred Heart Hospital — Anyang
• Bucheon Sejong Hospital — Bucheon-si
• Dong-A University Hospital — Busan
• Pusan National University Hospital — Busan
• Pusan National University Yangsan Hospital — Busan
• Changwon Gyeongsang National University Hospital — Changwon
• … and 34 more centers

Japan · 3 centers

• Japanese Red Cross Musashino Hospital — Tokyo
• NTT East Japan Kanto Hospital — Tokyo
• Tsuchiura Kyodo General Hospital — Tsuchiura

Hong Kong · 2 centers

• Princess Margret Hospital( HongKong) — Hong Kong
• Queen Mary Hospital — Hong Kong

India · 1 center

• Manipal Hospital — Bangalore

Taiwan · 1 center

• Cheng Hsin General Hospital — Taipei

Identifiers

NCT: NCT05829889 · AMCCV2023-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗