Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05896501
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-13
First Post:
2023-05-31
Brief Title:
Role of FFR in ACS Patients Pressure ACS Registry
Sponsor:
The Catholic University of Korea
Organization:
The Catholic University of Korea
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 disease4 FFR may be overestimated and the hemodynamic relevance of a coronary stenosis underestimated in patients with acute coronary syndrome ACSIts 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None