Status:
COMPLETED
Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (F.A.M.E.)
Lead Sponsor:
Stanford University
Conditions:
Coronary Arteriosclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
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. Pa...
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...
Eligibility Criteria
Inclusion
- at least 2 coronary lesions of 50% stenosis or greater in at least 2 major epicardial arteries
- age\>/=18
Exclusion
- - STEMI \< 5 days ago or non-STEMI with CK \> 1000 U/l \< 5 days ago
- Pregnancy
- Extremely tortuous or calcified coronary arteries, or other technical conditions interfering with reliable coronary pressure measurement
- Serious concomitant disease, decreasing life expectancy to \<2 years
- Previous coronary bypass surgery (CABG)
- Contraindication for drug-eluting stent
- Cardiogenic shock
- Inability to give informed consent
- Suspicion of significant left main (LM) stenosis
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
1005 Patients enrolled
Trial Details
Trial ID
NCT00267774
Start Date
January 1 2006
End Date
September 1 2015
Last Update
November 13 2017
Active Locations (2)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305
2
Catharina Hospital
Eindhoven, Netherlands