Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06159231
Status:
RECRUITING
Last Update Posted:
2023-12-06
First Post:
2023-03-30
Brief Title:
FAME II-10-year Follow-Up
Sponsor:
CoreAalst BV
Organization:
CoreAalst BV
Study Overview
Official Title:
Fractional Flow Reserve-guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease - FAME II a 10-year Follow-up Study
Status:
RECRUITING
Status Verified Date:
2023-03
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:
FAME2-10yFU
Brief Summary:
The FAME-II trial was a prospective multicenter multinational multi-continental randomized clinical trial with an all comers design
The overall purpose of the FAME-II trial was to compare the clinical outcomes safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment OMT versus OMT alone in patients with stable coronary artery disease and in whom both PCI and medical treatment can be considered on the basis of the presently existing scientific evidence
FAME-II was conducted from 2009 to 2012 and 1-year 2-year and 5-year results have been published
The purpose of this 10-Year Follow-up is to evaluate the 10-year major adverse cardiac event rate MACE defined as all-cause death documented myocardial infarction unplanned hospitalization leading to urgent revascularization
Patients will have to sign a specific informed consent for the present 10-year follow-up
This study will be conducted for about approximately 6 months
The overall purpose of the FAME-II trial was to compare the clinical outcomes safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment OMT versus OMT alone in patients with stable coronary artery disease and in whom both PCI and medical treatment can be considered on the basis of the presently existing scientific evidence
FAME-II was conducted from 2009 to 2012 and 1-year 2-year and 5-year results have been published
The purpose of this 10-Year Follow-up is to evaluate the 10-year major adverse cardiac event rate MACE defined as all-cause death documented myocardial infarction unplanned hospitalization leading to urgent revascularization
Patients will have to sign a specific informed consent for the present 10-year follow-up
This study will be conducted for about approximately 6 months
Detailed Description:
None
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