myocardial infarction
Conditions
Interventions
DEB-treatment of LRP, as detected with IVUS/NIRS
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient has an acute coronary syndrome without ST-segment elevation on the ECG (NSTE-ACS), includingnon-ST-elevation myocardial infarction and unstable angina pectoris. 2. An invasive revascularization strategy for NSTE-ACS with PCI is chosen.
Exclusion criteria
Exclusion criteria: Angiographic exclusion criteria: 1. Previous coronary artery bypass-grafting; 2. A chronic total occlusion is present; 3. Too many (complex) coronary lesions requiring staged PCI procedure(s); 4. Procedural complication of the index PCI; Clinical exclusion criteria: 5. Unstable patients (the presence of cardiogenic shock, need for intubation, need for inotropes); 6. Patients with ST-segment elevations on the ECG requiring immediate primary PCI; 7. Body weight > 250 kg; 8. Known renal insufficiency (estimated Glomerular Filtration Rate [eGFR]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in LCBImm4 between baseline and 9 months in DEB-treated LRPs | — |
Secondary
| Measure | Time frame |
|---|---|
| • The change in lipid-core burden index in a 4 mm segment (LCBImm4) as measured with IVUS + NIRS from baseline to 9 month follow-up in identified additional LRPs that are not treated with DEB. • Flow-limiting dissection necessitating bail-out stent implantation; • Periprocedural myocardial infarction; • LRP lesion failure, defined as cardiac death, myocardial infarction, or ischemia-driven revascularization related to an identified non-culprit LRP lesion up to one-year follow-up; • Patient-oriented composite outcomes, defined as all-cause mortality, myocardial infarction, or any repeat revascularization up to one-year follow-up; • Additional IVUS + NIRS lesion characteristics (plaque volume, minimal lumen area). | — |
Countries
Netherlands
Outcome results
None listed