Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267774
Status:
COMPLETED
Last Update Posted:
2017-11-13
First Post:
2005-12-19
Brief Title:
Fractional Flow Reserve Versus Angiography for Multivessel Evaluation FAME
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2017-10
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:
In this multicenter international study we are evaluating two approaches to determine which coronary artery narrowings require stent placement in patients with multivessel coronary artery disease Patients will be randomized to an angiographic strategy where only coronary angiography is used to determine which lesions to stent or to a pressure wire strategy where fractional flow reserve an index measured with the pressure wire will be used to determine which lesions to stent The primary outcome will be major adverse cardiac events at 1 year A secondary outcome will be cost-effectiveness
Detailed Description:
Detailed protocol
If a patient is eligible for the study see inclusion and exclusion criteria and has given informed consent the operator has to define all lesions with a stenosis severity of at least 50 by visual estimate in which he would consider stent implantation These stenoses are noted on a scheme of the coronary arteries before randomization
Thereafter randomization is performed to the FFR-guided strategy or the angiography-guided strategy If the patient is randomized to the angiography-guided strategy all the lesions indicated beforehand will be stented with drug-eluting stents If the patient is assigned to the FFR-guided group fractional flow reserve is measured in all lesions and only those lesions are stented with a fractional flow reserve 080 Treatment after PCI is according to local routine and should include at least aspirin 80 mg daily and clopidogrel Plavix 75 mg per day for at least 12months
FFR should be determined by using iv adenosine 140 µgkgmin in order to make pull-back recordings and analyze different abnormalities along the coronary arteries Adenosine iv by the femoral venous route is mandatory for participation in the study
In case of serial stenosis FFR of the complete vessel should be 080 to warrant PCI of one of more of these lesions in case the patient belongs to the FFR-guided group In case of the angio-guided group every lesion 50 by visual estimation that the operator indicated a prior as requiring stenting should be stented this is mandatory Long stents to cover a segment or multiple shorter stents can be placed at the discretion of the operator
Follow-up
All patients will be followed up after 1 month 1 week 6 months 1 month and 1 year 1 month All adverse cardiac events death acute MI CABG or re-PCI will be noted as well as functional class and number of anti-anginal drugs If a patient is admitted to a hospital because of an acute coronary syndrome repeat angiography is strongly advocated to define if the event is related to one of the deferred lesions or to one of the non-deferred lesions If the patient belongs to the FFR-guided arm repeat measurement of FFR is advocated for all lesions If during follow-up patients in the FFR-guided group have to undergo coronary angiography because of recurrent angina or any other reason without an event pressure measurement should be repeated as well
On the contrary once a patient has been assigned to the angiographic guided group this strategy should be followed consistently during follow-up investigations For example if a patient in the angiographic guided arm has recurrent chest pain undergoes angiography and is found to have in-stent restenosis re-PCI should be performed based on the angiogram and pressure wire use is prohibited
In other words the strategy to which the patient has been assigned initially should be followed during the entire study period
Endpoints
Primary endpoints
1 The primary clinical endpoint is the 12-month binary major adverse cardiac event MACE rate MACE is defined as
All cause death
Documented myocardial infarction
Repeat revascularization PCI andor CABG as adjudicated by the Clinical Event Committee
Secondary endpoints
1 Global cost effectiveness after one year
2 Cardiac death and myocardial infarction rate at 1 year
3 Functional class at 1 year
4 Number of anti-anginal drugs after 1 year
5 Overall MACE rate at 1 month post-procedure and at 6 months 2 3 and 5 years
6 A comparison of outcomes based on type of drug-eluting stent
7 Prognostic value of FFR after stenting
8 Correlation between FFR and nuclear perfusion imaging
If a patient is eligible for the study see inclusion and exclusion criteria and has given informed consent the operator has to define all lesions with a stenosis severity of at least 50 by visual estimate in which he would consider stent implantation These stenoses are noted on a scheme of the coronary arteries before randomization
Thereafter randomization is performed to the FFR-guided strategy or the angiography-guided strategy If the patient is randomized to the angiography-guided strategy all the lesions indicated beforehand will be stented with drug-eluting stents If the patient is assigned to the FFR-guided group fractional flow reserve is measured in all lesions and only those lesions are stented with a fractional flow reserve 080 Treatment after PCI is according to local routine and should include at least aspirin 80 mg daily and clopidogrel Plavix 75 mg per day for at least 12months
FFR should be determined by using iv adenosine 140 µgkgmin in order to make pull-back recordings and analyze different abnormalities along the coronary arteries Adenosine iv by the femoral venous route is mandatory for participation in the study
In case of serial stenosis FFR of the complete vessel should be 080 to warrant PCI of one of more of these lesions in case the patient belongs to the FFR-guided group In case of the angio-guided group every lesion 50 by visual estimation that the operator indicated a prior as requiring stenting should be stented this is mandatory Long stents to cover a segment or multiple shorter stents can be placed at the discretion of the operator
Follow-up
All patients will be followed up after 1 month 1 week 6 months 1 month and 1 year 1 month All adverse cardiac events death acute MI CABG or re-PCI will be noted as well as functional class and number of anti-anginal drugs If a patient is admitted to a hospital because of an acute coronary syndrome repeat angiography is strongly advocated to define if the event is related to one of the deferred lesions or to one of the non-deferred lesions If the patient belongs to the FFR-guided arm repeat measurement of FFR is advocated for all lesions If during follow-up patients in the FFR-guided group have to undergo coronary angiography because of recurrent angina or any other reason without an event pressure measurement should be repeated as well
On the contrary once a patient has been assigned to the angiographic guided group this strategy should be followed consistently during follow-up investigations For example if a patient in the angiographic guided arm has recurrent chest pain undergoes angiography and is found to have in-stent restenosis re-PCI should be performed based on the angiogram and pressure wire use is prohibited
In other words the strategy to which the patient has been assigned initially should be followed during the entire study period
Endpoints
Primary endpoints
1 The primary clinical endpoint is the 12-month binary major adverse cardiac event MACE rate MACE is defined as
All cause death
Documented myocardial infarction
Repeat revascularization PCI andor CABG as adjudicated by the Clinical Event Committee
Secondary endpoints
1 Global cost effectiveness after one year
2 Cardiac death and myocardial infarction rate at 1 year
3 Functional class at 1 year
4 Number of anti-anginal drugs after 1 year
5 Overall MACE rate at 1 month post-procedure and at 6 months 2 3 and 5 years
6 A comparison of outcomes based on type of drug-eluting stent
7 Prognostic value of FFR after stenting
8 Correlation between FFR and nuclear perfusion imaging
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