CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,005 enrolled
Drug / intervention
Fractional flow reserve +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00267774
NCT00267774N/ACompleted

Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (F.A.M.E.)

Stanford University·interventional·Posted Dec 21, 2005·Updated Nov 13, 2017

In Brief

A clinical study evaluating Fractional flow reserve and Angio-guided PCI for Coronary Arteriosclerosis. Completed, enrolled 1,005 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands, United States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 21, 2005
Enrollment StartJan 1, 2006
Primary CompletionSep 1, 2008
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 20.5 years ago

Interventions

Fractional flow reservedevice

Angio-guided PCIprocedure