Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-01-02 @ 4:23 AM
Study NCT ID:
NCT01132495
Status:
COMPLETED
Last Update Posted:
2019-09-16
First Post:
2010-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT
Sponsor:
Abbott Medical Devices
Organization:
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
Status:
COMPLETED
Status Verified Date:
2019-08
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:
The overall purpose of the FAME II trial is 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.
Detailed Description:
Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: