| CTRI Number |
CTRI/2024/08/073132 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Treatment Strategy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of two standard operating procedure Fractional Flow Reserve method Versus Angiographic method in a patient with left Main Coronary Artery Disease for Treatment- decision and Evaluations |
|
Scientific Title of Study
|
A Comparison of Fractional Flow Reserve- versus Angiography-Guided Percutaneous Coronary Intervention in Patients with Left Main Coronary Artery Disease: FATE-MAIN Trial (Fractional Flow Reserve versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease) |
| Trial Acronym |
FATE-Main |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| AMCCV 2023-02 version 1.4 dated 03 July 2024 |
Protocol Number |
| KCT0009073 - Korean Clinical Research Information Service |
Other |
| NCT05829889 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chadha Davinder Singh |
| Designation |
Consultant Cardiologist |
| Affiliation |
Manipal Hospitals |
| Address |
Room No:06, Department of Cardiology, 1St Floor, No 98 Old Airport road, Bengaluru -560017, Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
8380963737 |
| Fax |
|
| Email |
drdschadha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chadha Davinder Singh |
| Designation |
Consultant Cardiologist |
| Affiliation |
Manipal Hospitals |
| Address |
Room No:06, Department of Cardiology, 1St Floor, No 98 Old Airport road, Bengaluru -560017, Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
8380963737 |
| Fax |
|
| Email |
drdschadha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chadha Davinder Singh |
| Designation |
Consultant Cardiologist |
| Affiliation |
Manipal Hospitals |
| Address |
Room No:06, Department of Cardiology, 1St Floor, No 98 Old Airport road, Bengaluru -560017, Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
8380963737 |
| Fax |
|
| Email |
drdschadha@gmail.com |
|
|
Source of Monetary or Material Support
|
| CVRF(Cardiovascular Research Foundation), Asan Medical Center 88, Olympic-ro 43-gil, Songpa-gu, Seoul- 05505 Republic of Korea |
|
|
Primary Sponsor
|
| Name |
Dr. Seung-Jung Park |
| Address |
88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Australia
Hong Kong
Japan
Republic of Korea
Taiwan |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chadha Davinder Singh |
Manipal Hospitals |
Room No:06, Department of Cardiology, 1St Floor NO 98 Old Airport Road, Bengaluru-560017, Karnataka
Bangalore
KARNATAKA |
8390963737
drdschadha@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Angiography-guided percutaneous coronary intervention (PCI) |
After 01-day procedure, Clinical follow-up will be performed at 1 month (± 14 days), 6 months (±2 months), 12 months (±2
months), 18 months (±2 months), 24 months (±2 months) |
| Intervention |
Fractional flow reserve (FFR)- guided percutaneous coronary intervention (PCI) |
After 01-day procedure, Clinical follow-up will be performed at 1 month (± 14 days), 6 months (±2 months), 12 months (±2
months), 18 months (±2 months), 24 months (±2 months) |
|
Inclusion Criteria
Modification(s)
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. The subject must be more than or equal to 20 years of age with angina and/or evidence of myocardial ischemia
2. Significant de novo LMCA disease, defined as more than or equal to 50% diameter stenosis by visual estimation with or without concomitant non-left main major epicardial CAD, amenable to PCI with 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.
|
|
| ExclusionCriteria |
| Details |
1. LAD or LCX CTO(RCA CTO only allowed)
2. Extremely calcified or tortuous vessels precluding FFR measurement.
3. The presence of complex coronary disease anatomy or lesion characteristics or other cardiac conditions which leads the participating interventional cardiologist to believe that PCI is not suitable (i.e. the subject should be managed with CABG or medical therapy alone)
4. Recent STEMI (Less than 7 Prior to randomization)
5. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
6. Severe left ventricular dysfunction (ejection fraction less than 30%)
7. Requirement for other cardiac surgical procedure (e.g., valve replacement or aorta surgery)
8. Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or clopidogrel)
9. Prior PCI of the left main trunk
10. Prior CABG
11. Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year
12. End-stage renal disease requiring renal replacement therapy
13. Liver cirrhosis
14. Women who are pregnant or breastfeeding or female subjects, premenopausal who are not surgically sterile, or, if sexually active not practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, who have a positive pregnancy test at screening
15. Concurrent medical condition with a limited life expectancy of less than 2 years
16.Patients 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 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
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Composite event of death from any causes, myocardial infarction (MI), or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, or repeat revascularization at 2 years after randomization. Subjects who die or are lost to follow up before 2 years will be censored at their last recorded activity. |
2 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Each individual component of primary composite outcome
|
2 Years |
| Death from any causes, cardiovascular causes, or noncardiovascular causes |
2 Years |
| MI (any, spontaneous or procedural) |
2 Years |
| Composite of death or MI |
2 Years |
| Stent thrombosis (ARC definition) |
2 Years |
| Stroke |
2 Years |
| Bleeding complications (Bleeding Academic Research Consortium (BARC) type 3–5 indicates severe bleeding) |
2 Years |
| Procedure time |
1 day |
| Amount of contrast agent used |
1 day |
| Length of hospital stay |
an average of 7 day |
| Rehospitalization (any, cardiac, or noncardiac causes) |
2 Years |
| Functional class (assessed by the CCS Classification) at each time point (discharge and follow up) |
7 days(discharge) and 1, 6, 12, 24 months |
| Angina-related quality of life index (by the Seattle Angina Questionnaire) |
7 days(discharge) and 1, 6, 12, 24 months |
| Health-related quality of life index (by the EQ-5D) at each time point (discharge and follow-up) |
7 days(discharge) and 1, 6, 12, 24 months |
| Number of anti-anginal medications used at each time point (discharge and follow-up) |
7 days(discharge) and 1, 6, 12, 24 months |
|
|
Target Sample Size
|
Total Sample Size="934"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/04/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
FATE-MAIN is an investigator-initiated, multicenter, international, randomized, controlled trial including up to 30 sites worldwide. Consecutive patients with significant LMCA disease who meet the inclusion criteria and none of the exclusion criteria outlined below will be randomized in a 1:1 fashion to either FFR-guided or angiography-guided PCI.
Patients with significant (as ≥50% diameter stenosis) LMCA stenosis undergoing PCI with drug-eluting stents (DES), routine measurement of FFR in addition to angiographic guidance, as compared with PCI guided by angiography alone, results in a significant reduction in major adverse cardiac events at 2 years, a finding that supports the evolving strategy of physiology-guided revascularization for ischemia-inducing LMCA lesions, but only medical therapy for non-ischemic LMCA lesions.
|