Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01132495 · ClinicalTrials.gov registry record · NA
FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT
A NA study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 1,170
- Enrollment target
NCT01132495: Completed NA study, sponsored by Abbott Medical Devices.
NCT01132495 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 1,170 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01132495, a NA study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,170 participants
- Enrollment target
Study 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.
Primary Outcome
MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.
Interventions
- OTHER Standard of care
- OTHER OMT
- OTHER Stenting plus OMT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,170 participants |
| Start Date | 2010-05 |
| Est. Completion | 2015-05 |
| Phase | NA |
What the finished NCT01132495 record still lists
NCT01132495 is an interventional study that assigns participants to a tested intervention. Its 1,170 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 3 interventions - of which Standard of care is the first listed.
NCT01132495 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01132495 about?
NCT01132495 is a clinical study titled "FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT". 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.
What is the current status of trial NCT01132495?
This trial is currently completed. It is a NA study. The enrollment target is 1,170 participants. The study started on 2010-05. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01132495?
The interventions under investigation include: Standard of care (OTHER), OMT (OTHER), Stenting plus OMT (OTHER).
Who is sponsoring clinical trial NCT01132495?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01132495's enrollment target sits among peer trials
1,170 90th of 2000 higher than 1,911 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06469788 · 1,170 participants · NA
Testimonials and Navigation in Rheumatology
- NCT04275557 · 1,174 participants
Using Radiogenomics to Predict Malignant Potential of Intraductal Papillary Mucinous Neoplasms of the Pancreas
- NCT07009509 · 1,166 participants · NA
Pilot Study of the YES-CAN! Program to Prevent Youth Nicotine Vaping
- NCT06133322 · 1,176 participants · NA
Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia