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

Primary Purpose

Coronary Artery Disease Left Main, Coronary Artery Disease

Status
Not yet recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
FFR-Guided PCI
Angiography-Guided PCI
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease Left Main focused on measuring Fractional Flow Reserve, Percutaneous Coronary Intervention

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FFR-guided Left Main PCI

Angiography-Guided PCI

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The event rate of death from any causes
The event rate of myocardial infarction
any, spontaneous or procedural myocardial infarction
The event rate of hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest
The event rate of repeat revascularization
The composite event rate of death or myocardial infarction
The event rate of stent thrombosis
Stent thrombosis by Academic Research Consortium (ARC) definition
The event rate of stroke
The event rate of bleeding complications
Bleeding Academic Research Consortium [BARC] type 3-5, which indicates severe bleeding
Procedure time
Amount of contrast agent used
Length of hospital stay
The event rate of rehospitalization
Rehospitalization from any, cardiac, or noncardiac causes
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.
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.
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.
Number of anti-anginal medications

Full Information

First Posted
March 30, 2023
Last Updated
August 24, 2023
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT05829889
Brief Title
Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease
Acronym
FATE-MAIN
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease Left Main, Coronary Artery Disease
Keywords
Fractional Flow Reserve, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
934 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FFR-guided Left Main PCI
Arm Type
Experimental
Arm Title
Angiography-Guided PCI
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
FFR-Guided PCI
Intervention Description
Fractional Flow Reserve-Guided PCI
Intervention Type
Procedure
Intervention Name(s)
Angiography-Guided PCI
Intervention Description
Angiography-Guided PCI
Primary Outcome Measure Information:
Title
The composite event rate
Description
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
Secondary Outcome Measure Information:
Title
The event rate of death from any causes
Time Frame
2 years
Title
The event rate of myocardial infarction
Description
any, spontaneous or procedural myocardial infarction
Time Frame
2 years
Title
The event rate of hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest
Time Frame
2 years
Title
The event rate of repeat revascularization
Time Frame
2 years
Title
The composite event rate of death or myocardial infarction
Time Frame
2 years
Title
The event rate of stent thrombosis
Description
Stent thrombosis by Academic Research Consortium (ARC) definition
Time Frame
2 years
Title
The event rate of stroke
Time Frame
2 years
Title
The event rate of bleeding complications
Description
Bleeding Academic Research Consortium [BARC] type 3-5, which indicates severe bleeding
Time Frame
2 years
Title
Procedure time
Time Frame
1 day
Title
Amount of contrast agent used
Time Frame
1 day
Title
Length of hospital stay
Time Frame
an average of 7 day
Title
The event rate of rehospitalization
Description
Rehospitalization from any, cardiac, or noncardiac causes
Time Frame
2 years
Title
Functional class
Description
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
Title
Change of angina-related quality of life index
Description
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
Title
Change of health-related quality of life index
Description
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
Title
Number of anti-anginal medications
Time Frame
7 days(discharge) and 1, 6, 12, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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: 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. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Duk-woo Park, MD
Email
dwpark@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duk-woo Park, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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