At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,170 enrolled
Drug / intervention
Stenting plus OMT +2 moreother
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.
Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease
In Brief
A clinical study evaluating Stenting plus OMT, OMT, and 1 other intervention for Coronary Artery Disease. Completed, enrolled 1,170 participants across 29 sites in 13 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesBelgium, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Serbia, Sweden, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2010
First PostedMay 2010
Primary CompletionJan 2014
Study CompletionMay 2015
TodayJul 2026
First PostedMay 28, 2010
Enrollment StartMay 1, 2010
Primary CompletionJan 1, 2014
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 16.1 years ago
Interventions
Stenting plus OMTother
FFR guided PCI, plus OMT
OMTother
OMT alone
Standard of careother
FFR \> 0.80; treatment according to local practice