Acute coronary syndrome, myocardial infarction Heart attack
Conditions
Interventions
PCB-treatment of lipid-rich plaque, as detected with IVUS/NIRS.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older Presenting with acute coronary syndrome, consisting of unstable angina pectoris or acute myocardial infarction with or without ST-segment elevation Successful PCI of a native coronary artery or major side branch At least 2 native coronary arteries are accessible for invasive coronary imaging; i.e. not totally occluded and >2 mm and <6 mm reference vessel diameter.
Exclusion criteria
Exclusion criteria: Hemodynamically unstable (presence of cardiogenic shock, need for intubation, need for inotropes); Known hypersensitivity to paclitaxel; Procedural complications of the index PCI; Known renal insufficiency, i.e. eGFR <30 mL/min/1.73 m2; Hypersensitivity or allergy to contrast with inability to administer steroid and antihistamine premedication;Presence of a comorbid condition with a life expectancy of less than one year; Body weight >250 kg; Subject belonging to a vulnerable population (per investigator’s judgment, e.g., subordinate hospital staff) or is unable to read or write.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in maxLCBImm4 reduction from baseline to 9 months follow-up compared between the two randomization groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary imaging endpoints: The change in lipid-core burden index in maxLCBI4mm as measured with IVUS + NIRS from baseline to 9 month follow-up in identified additional LRPs that are not treated with DCB. The change in IVUS- and angiography-derived measurements (plaque burden, minimal lumen area, mean plaque area, diameter stenosis and minimal lumen diameter). The change in CCTA-derived measurements (total plaque volume, non-calcified plaque volume, calcified plaque volume, lumen volume and presence of the following high-risk plaque features: positive remodeling [remodeling index >1.1], spotty calcification, napkin ring morphology and low-density plaque).Secondary clinical endpoints: Flow-limiting dissection necessitating bail-out stent implantation; Periprocedural myocardial infarction; Bleeding (BARC-3 and -5)LRP lesion failure, defined as cardiovascular 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; | — |
Countries
Denmark, Germany, Netherlands, Sweden
Contacts
Public ContactT.N. Dijkstra
Amsterdam UMC
Outcome results
None listed