coronary artery disease coronary narrowing
Conditions
Interventions
iFR- versus FFR-guided decision making on revascularisation or deferral of
coronary stenoses
Sponsors
Imperial College London
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age>18 years of age 2. Willing to participate and able to understand, read, and sign the informed consent document before the planned procedure. 3. Eligible for coronary angiography and/or percutaneous coronary intervention 4. Coronary artery disease in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed de novo coronary stenosis in which the physiological severity of the lesion is in question (typically 40-70% diameter stenosis). 5. Stable angina or ACS (non-culprit vessels only and outside of primary intervention during acute STEMI)
Exclusion criteria
Exclusion criteria: 1. Previous CABG with patents grafts to the interrogated vessel 2. Left main stenosis 3. Tandem stenoses separated by more than 10mm that require separate pressure guide wire interrogation or PCI (not to be interrogated or treated as a single stenosis). 4. total coronary occlusions. 5. Restenotic lesions. 6. Haemodynamic instability at the time of intervention (heart rate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiac events (MACE) rate in the oFR and FFR groups at 30 days, 1, 2, and 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Death (all cause) at 30 days, 1, 2, and 5 years. 2. Death (cardiovascular) at 30 days, 1, 2, and 5 years. 3. Myocardial infarction at 30 days, 1, 2, and 5 years. 4. Repeat revascularization by PCI or coronary artery bypass graft surgery (CABG) at 30 days, 1, 2, and 5 years. 5. Costs associated with iFR or FFR guidance. 6. Quality of Lide (QOL) of patients included in the iFR or FFR guidance groups 7. Cost savings of removing secondary inverigations, by assessing.treating non-culprit acute coronary syndrome (ACS) at the time of index presentation. | — |
Countries
Netherlands
Outcome results
None listed