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Active Not RecruitingNCT05896501

Role of FFR in ACS Patients: Pressure ACS Registry

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
500 (actual)
Sponsor
The Catholic University of Korea · Academic / Other
Sex
All
Age
19 Years – 85 Years
Healthy volunteers

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.

Detailed description

STUDY OBJECTIVE 1. To evaluate the impact of FFR on decision for PCI in ACS patients 2. 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 3. To identify the relation between OCT findings and FFR value in culprit and non-culprit lesions of ACS patients 4. To compare the long term prognosis of PCI or deferring PCI based on FFR value in non-culprit lesion of ACS patients 5. To identify OCT findings to predict the lesion progression in deferred lesions. 6. To assess the long term prognosis of post-PCI FFR value in the culprit lesion of NSTE-ACS patients 7. To assess the efficacy of routine use of FFR to guide PCI in ACS patients; angiographically guidance versus FFR guidance

Conditions

Interventions

TypeNameDescription
DEVICEFractional Flow ReserveFunctional assessement of anatomical stenosis of coronary artery

Timeline

Start date
2020-01-01
Primary completion
2025-12-31
Completion
2026-12-31
First posted
2023-06-09
Last updated
2024-10-02

Locations

5 sites across 1 country: South Korea

Source: ClinicalTrials.gov record NCT05896501. Inclusion in this directory is not an endorsement.