Status:
COMPLETED
FAME II-10-year Follow-Up
Lead Sponsor:
CoreAalst BV
Collaborating Sponsors:
Abbott Medical Devices
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
21+ years
Brief 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 ...
Eligibility Criteria
Inclusion
- Patients with
- stable angina pectoris (Canadian Cardiovascular Society Class \[CCS\] 1, 2, 3)
- or, angina pectoris CCS class 4 subsequently stabilized medically (minimum 7 days) or,
- atypical chest pain or no chest pain but with documented silent ischemia on non-invasive testing.
- In whom at least one stenosis was present of at least 50% in one major native epicardial coronary artery with a diameter of at least 2.5 mm and supplying viable myocardium
- Eligible for PCI
- Signed written informed consent was obtained. Patients will have to sign a specific informed consent for the present 10-year follow-up.
Exclusion
- Patients in whom the preferred treatment is CABG
- Patients with left main coronary artery disease requiring revascularization
- Patients with a recent (less than 1 WEEK) STEMI or Non-STEMI
- Prior CABG
- Contra-indication to dual antiplatelet therapy
- LVEF \< 30%
- Severe LV hypertrophy (defined as a septal wall thickness at echocardiography of more than 13 mm)
- Planned need for concomitant cardiac surgery (e.g., valve surgery or resection of aortic or left ventricular aneurysm etc.)
- Extremely tortuous or calcified coronary arteries precluding FFR measurements
- A life expectancy of less than 2 years
- Age under 21
- Pregnancy or intention to become pregnant during the course of the trial
- Refusal or inability to sign an informed consent. Mental condition (psychiatric or organ cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the trial or mental retardation or language barrier such that the patient is unable to give informed consent
- Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits
- Participation or planned participation in another cardiovascular clinical trial before two year follow-up is completed
Key Trial Info
Start Date :
April 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 15 2024
Estimated Enrollment :
888 Patients enrolled
Trial Details
Trial ID
NCT06159231
Start Date
April 25 2023
End Date
May 15 2024
Last Update
January 7 2025
Active Locations (16)
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1
Stanford University Medical Center
Stanford, California, United States, 94305
2
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
3
Northern Light Eastern Maine Medical Center
Bangor, Maine, United States, 04401
4
Cardiovascular Center Aalst
Aalst, Belgium, 9300