Trials / Active Not Recruiting
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Fractional Flow Reserve | Functional 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.