Trials / Completed
CompletedNCT01132495
FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT
Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,170 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Stenting plus OMT | FFR guided PCI, plus OMT |
| OTHER | OMT | OMT alone |
| OTHER | Standard of care | FFR \> 0.80; treatment according to local practice |
Timeline
- Start date
- 2010-05-01
- Primary completion
- 2014-01-01
- Completion
- 2015-05-01
- First posted
- 2010-05-28
- Last updated
- 2019-09-16
- Results posted
- 2016-12-09
Locations
29 sites across 13 countries: United States, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Serbia, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01132495. Inclusion in this directory is not an endorsement.