Ignite Creation Date:
2024-05-06 @ 2:40 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02100722
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2014-03-21
Brief Title:
A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Fractional Flow Reserve Versus Angiography for Multivessel Evaluation FAME 3 Trial A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
FAME 3
Brief Summary:
The purpose of this study is to determine whether Fractional flow reserve FFR coronary pressure wire-based index for assessing the ischemic potential of a coronary lesion-guided percutaneous coronary intervention PCI in patients with multivessel coronary artery disease CAD will result in similar outcomes to coronary artery bypass graft surgery CABG
Detailed Description:
The FAME 3 trial is a multicenter international randomized controlled noninferiority trial All patients with multivessel CAD not involving the left main will be screened by the sites Heart Team including but not limited to an interventional cardiologist cardiac surgeon and research coordinator If all agree that the patient can be treated either with FFR-guided PCI or CABG and all inclusion criteria are met and no exclusion criteria are met then the patient will be randomized
Baseline clinical functional laboratory and electrocardiographic data will be obtained Patients will receive treatment within 4 weeks of randomization Patients randomized to CABG will receive state of the art therapy at the discretion of the local surgeon with a strong emphasis on arterial revascularization Patients undergoing PCI will have FFR measured with a St Jude Medical coronary pressure wire across all lesions If the FFR is 080 then PCI will be performed with the Medtronic Resolute Integrity drug-eluting stent DES as per usual routine If the FFR is 080 then PCI will be deferred
All patients will receive medical therapy as per published guidelines Patients will follow-up at 1 and 6 months and 1 and 3 years with an evaluation of clinical status functional status medications and events Follow-up may be extended to 5 years if funding allows
Core lab analyses will include formal quantitative coronary angiography QCA of the baseline angiograms with calculation of the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery SYNTAX score and Functional SYNTAX Score
Baseline clinical functional laboratory and electrocardiographic data will be obtained Patients will receive treatment within 4 weeks of randomization Patients randomized to CABG will receive state of the art therapy at the discretion of the local surgeon with a strong emphasis on arterial revascularization Patients undergoing PCI will have FFR measured with a St Jude Medical coronary pressure wire across all lesions If the FFR is 080 then PCI will be performed with the Medtronic Resolute Integrity drug-eluting stent DES as per usual routine If the FFR is 080 then PCI will be deferred
All patients will receive medical therapy as per published guidelines Patients will follow-up at 1 and 6 months and 1 and 3 years with an evaluation of clinical status functional status medications and events Follow-up may be extended to 5 years if funding allows
Core lab analyses will include formal quantitative coronary angiography QCA of the baseline angiograms with calculation of the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery SYNTAX score and Functional SYNTAX Score
Study Oversight
Has Oversight DMC:
None
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?:
None