CES1 Carriers in the PAPI Study
NCT03188705
Arterial Occlusive Diseases, Arteriosclerosis
Lancaster, Pennsylvania, United States
View Trial DetailsNCT Number: NCT06159231
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.
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Notify Me21 year and older
All sexes
Observational
Cardiovascular Center Aalst, Aalst, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 10 years
10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization).
Time frame: 10 years
Comparison of the rate of all-cause death between randomization arms (of the original FAME2 study).
Time frame: 10 years
Comparison of the rate of documented myocardial infarction between randomization arms (of the original FAME2 study).
Time frame: 10 years
Comparison of the rate of unplanned hospitalization leading to urgent revascularization between randomization arms (of the original FAME2 study).
CoreAalst BV
Industry
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.
Acronym: FAME2-10yFU
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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