Coronary Artery Disease Clinical Trial
Official title:
Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease
| NCT number | NCT01132495 |
| Other study ID # | 0904 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2010 |
| Est. completion date | May 2015 |
| Verified date | August 2019 |
| Source | Abbott Medical Devices |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1170 |
| Est. completion date | May 2015 |
| Est. primary completion date | January 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility |
Inclusion Criteria: 1. Patients with - stable angina or, - stabilized angina pectoris or, - atypical chest pain or no chest pain but with documented silent ischemia 2. at least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium 3. Eligible for PCI 4. Signed written informed consent Exclusion Criteria: 1. Patients in whom the preferred treatment is CABG 2. Patients with left main coronary artery disease requiring revascularization 3. Patients with a recent STEMI or Non-STEMI 4. Prior CABG 5. Contra-indication to dual antiplatelet therapy 6. LVEF < 30% 7. Severe LV hypertrophy 8. Planned need for concomitant cardiac surgery 9. Extremely tortuous or calcified coronary arteries precluding FFR measurements 10. A life expectancy of less than 2 years 11. Age under 21 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | OLV Ziekenhuis | Aalst | |
| Canada | Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec |
| Canada | Hopital du Sacre-Coeur de Montreal | Montreal | Quebec |
| Czechia | Masaryk University and University Hospital Brno | Brno | |
| Czechia | Na Homolce Hospital | Praha | |
| Denmark | Rigshospitalet University Hospital | Copenhagen | |
| France | Hospices Civils de Lyon | Bron | |
| Germany | Heart Center Leipzig | Leipzig | |
| Germany | Klinikum der Universitat Munchen | Munchen | |
| Germany | Stadtisches Klinikum Munchen | Munchen | |
| Hungary | Gottsegen Hungarian Institute of Cardiology | Budapest | |
| Italy | Azienda Ospedaliero Universitaria de Ferrara | Ferrara | |
| Netherlands | Catharina-Ziekenhuis | Eindhoven | |
| Netherlands | St. Antonius Ziekenhuis | Nieuwegein | |
| Netherlands | Isala Klinieken | Zwolle | |
| Serbia | Clinical Center Kragujevac | Kragujevac | |
| Sweden | Orebro University Hospital | Orebro | |
| Sweden | Sodersjukhuset AB | Stockholm | |
| United Kingdom | Royal Victoria Hospital | Belfast | |
| United Kingdom | Edinburgh Heart Centre | Edinburgh | |
| United Kingdom | Golden Jubilee National Hospital | Glasgow | |
| United Kingdom | Kings College Hospital | London | |
| United Kingdom | Southampton University Hospitals NHS | Southampton | |
| United States | Emory University | Atlanta | Georgia |
| United States | Northeast Cardiology Associates | Bangor | Maine |
| United States | Atlanta VA Medical Center | Decatur | Georgia |
| United States | Tulane University | New Orleans | Louisiana |
| United States | VA Palo Alto | Palo Alto | California |
| United States | Stanford University Medical Center | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Medical Devices |
United States, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Serbia, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Major Adverse Cardiac Event Rate (MACE) | MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization. | 24 Month | |
| Secondary | Overall MACE | Individual components of the primary end point, cardiac death, and nonurgent revascularization | 3 years |
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