Role of FFR in ACS Patients: Pressure ACS Registry

Sponsor

The Catholic University of Korea (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05896501

Collaborator

(none)

500

Enrollment

Locations

65.9

Anticipated Duration (Months)

100

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Currently, fractional flow reserve (FFR) is regarded as a gold-standard invasive method to define lesion-specific ischemia and FFR-guided PCI has been proven to reduce unnecessary revascularization and to enhance patient's clinical outcomes. Therefore, current guidelines recommend FFR measurement for intermediate coronary stenosis when there is no definite evidence of lesion-specific ischemia. However, previous evidences which well demonstrated the benefit of FFR-guided strategy were mostly generated from patients with stable coronary artery disease.4 FFR may be overestimated and the hemodynamic relevance of a coronary stenosis underestimated in patients with acute coronary syndrome (ACS).Its role in ACS patients still needs to be defined although several studies have recently published addressing the value of FFR-guided PCI in ACS. In fact, recent evidence suggests that culprit lesions of patients presenting with a non-ST-segment elevation myocardial infarction that were deferred based on a "negative" FFR have a relatively high event rate, calling into question the use of FFR in that patient population.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Device: Fractional Flow Reserve

Detailed Description

STUDY OBJECTIVE

To evaluate the impact of FFR on decision for PCI in ACS patients
To assess the long term prognosis of deferring PCI based on FFR value in non-culprit lesion; defying the cut-off value of FFR for PCI in the non-culprit lesion of ACS patients
To identify the relation between OCT findings and FFR value in culprit and non-culprit lesions of ACS patients
To compare the long term prognosis of PCI or deferring PCI based on FFR value in non-culprit lesion of ACS patients
To identify OCT findings to predict the lesion progression in deferred lesions.
To assess the long term prognosis of post-PCI FFR value in the culprit lesion of NSTE-ACS patients
To assess the efficacy of routine use of FFR to guide PCI in ACS patients; angiographically guidance versus FFR guidance

Study Design

Study Type:

Observational

Actual Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Role of Fractional Flow Reserve Assessment Using Pressure Wire in Patients With Acute Coronary Syndrome Who Treated With Xience Stent; a Multicenter, Prospective, and Observational Registry

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Jun 30, 2025

Outcome Measures

Primary Outcome Measures

Rate of Major adverse cardiac events [24 months]
Rate of the composite of all-cause death, recurrent myocardial infarction

Secondary Outcome Measures

Rate of Major adverse cardiac events at 1 year [12 months]
Rate of composite of all-cause death, recurrent myocardial infarction
Rate of Ischemic events [24 months]
Rate of the composite of all-cause death, recurrent myocardial infarction, and any repeat revascularization
Rate of Death [24 months]
Rate of All cause death and cardiac death
Rate of Repeat revascularization [24 months]
Rate of Any repeat revascularization

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 85 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Subject age 19-85 years old
Diagnosed as ACS (unstable angina/ Non ST elevation myocardial infarction, ST elevation myocardial infarction)
At least one stenosis of >50% in a non-culprit vessel ≥ 2.0 mm by visual estimation with TIMI 3 - multivessel disease after PCI for culprit lesion or single vessel disease with ambiguity for PCI ④ FFR within hospitalization for index PCI for ACS

Exclusion Criteria:

Severe stenosis with TIMI flow ≤ II of the non-IRA artery
Cardiogenic shock (Killip class IV) already at presentation or the completion of culprit PCI
Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus
Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)

⑤ Pregnancy or breast feeding

⑥ Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol noncompliance (per site investigator's medical judgment).

⑦ Other primary valvular disease with severe degree: severe mitral regurgitation or mitral stenosis, severe aortic regurgitation or aortic stenosis

⑧ Patients with a history of Coronary Artery Bypass Graft(CABG)

⑨ Unwillingness or inability to comply with the procedures described in this protocol.

Contacts and Locations

Locations

	Site	City	State	Country
1	St.Vincent's Hospital	Suwon	Gyeonggido	Korea, Republic of
2	Uijeongbu St.Mary's Hospital	Uijeongbu	Gyeonggido	Korea, Republic of
3	Daejeon St.Mary's Hospital	Daejeon		Korea, Republic of
4	Incheon St.Mary's Hospital	Incheon		Korea, Republic of
5	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

The Catholic University of Korea

Investigators

Principal Investigator: Eun Ho Choo, M.D.,PhD, The Catholic University of Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eun Ho Choo, Assistant Professor, The Catholic University of Korea

ClinicalTrials.gov Identifier:

NCT05896501

Other Study ID Numbers:

PressureACS

First Posted:

Jun 9, 2023

Last Update Posted:

Jun 13, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acute Coronary Syndrome

Syndrome

Study Results

No Results Posted as of Jun 13, 2023