Trials / Completed
CompletedNCT06159231
FAME II-10-year Follow-Up
Fractional Flow Reserve-guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients with Stable Coronary Artery Disease - FAME II, a 10-year Follow-up Study.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 888 (actual)
- Sponsor
- CoreAalst BV · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The FAME-II trial was a prospective, multicenter, multinational, multi-continental, randomized clinical trial with an 'all comers' design. The overall purpose of the FAME-II trial was 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 and in whom both PCI and medical treatment can be considered on the basis of the presently existing scientific evidence. FAME-II was conducted from 2009 to 2012 and 1-year, 2-year and 5-year results have been published. The purpose of this 10-Year Follow-up is to evaluate the 10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization). Patients will have to sign a specific informed consent for the present 10-year follow-up. This study will be conducted for about approximately 6 months.
Conditions
Timeline
- Start date
- 2023-04-25
- Primary completion
- 2024-05-15
- Completion
- 2024-05-15
- First posted
- 2023-12-06
- Last updated
- 2025-01-07
Locations
16 sites across 11 countries: United States, Belgium, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Serbia, Sweden
Source: ClinicalTrials.gov record NCT06159231. Inclusion in this directory is not an endorsement.