Health Condition 1: I209- Angina pectoris, unspecified Health Condition 2: I251- Atherosclerotic heart disease of native coronary artery Health Condition 3: I222- Subsequent non-ST elevation (NSTEMI) myocardial infarction Health Condition 4: I229- Subsequent ST elevation (STEMI) myocardial infarction of unspecified site
Conditions
Interventions
Intervention1: Diagnostic FFR & OCT guided PCI revascularization (experimental arm): FFR & OCT guided PCI revascularization
Intervention2: FFR & OCT guided PCI revascularization: FFR & OCT guided PCI
Sponsors
Erasmus Academical Hospital Universit Libre de Bruxelles
Eligibility
Inclusion criteria
Inclusion criteria: For this Investigator initiated study below are the inclusion criteria 1. Patients undergoing PCI, aged 30-80 years with any clinical presentation 2. Angiographic criteria: = 2 de novo target lesions located in 2 different native coronary arteries feasible for treatment with PCI (operator / Heart team decision) Angiographic criteria target lesion (all criteria I-IV should be applicable): I. Diameter stenosis (DS) = 50% II. De novo lesion located in native (non-grafted) vessel III. lesion reference diameter of = 2.0 mm IV. Thrombolysis In Myocardial Infarction (TIMI) 3 flow in all vessels (with exclusion of culprit lesions in patients with MI)
Exclusion criteria
Exclusion criteria: For this Investigator initiated study below are the exclusion criteria 1. Patients with MVD requiring coronary artery bypass grafting (CABG) treatment(operator / local heart team decision) 2. Lesion located in a grafted segment or in a vein graft 3. In-stent restenosis lesions 4. Left main trifurcation 5. Left main lesion stand-alone (without another lesion) 6. Patients with severe tortuous lesions (where FFR and OCT is judged impossible or dangerous) 7. Chronic total occlusion 8. Spontaneous coronary dissection 9. Patients with severe valvular heart disease likely to require cardiac surgery within the next 2 years 10. Patients with left ventricle (LV) function less than 30% Renal insufficiency (Glomerular Filtration Rate (GFR) 11. Life expectancy less than 3 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint is defined as composite of Cardiac death, any MI or any clinically driven revascularizationTimepoint: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac death, any MI or any clinical-driven revascularization excluding TLR events in patients with FFR between 0.75-0.80 left untreated in the experimental arm Cardiac death, any spontaneous MI or any clinically-driven revascularizationTimepoint: at 24 months | — |
Countries
Australia, Canada, Croatia, France, Hong Kong, India, Italy, Malaysia, Netherlands, New Zealand, Poland, Romania, Russian Federation, Singapore, Slovakia, Slovenia, Spain, Sweden, Taiwan
Contacts
Public ContactDr Tejas Patel
Apex Heart Institute
Outcome results
None listed