Intravascular ULTRA sound-guided percutaneous coronary intervention in patients with STEMI: Rationale and design of the ULTRA-STEMI trial

Table 3 Study endpoints for the ULTRA-STEMI trial

ULTRA-STEMI endpoints
Clinical/procedural	Primary endpoints
	Target vessel failure (36 months): Composite of cardiovascular death, target vessel myocardial infarction, clinically driven target vessel revascularization
	Cardiovascular death (36 months)
	Secondary endpoints
	MACE: Composite of cardiovascular mortality, any myocardial infarction and repeat revascularization
	Individual components of TVF and MACE
	Periprocedural data: Stent length and diameter, number and type of stents used, amount of contrast drug administered, total effective radiation dose, procedural duration
	In-hospital (post-PCI) adverse events: Composite of cardiac tamponade, need for CABG, shock, in-hospital mortality, acute kidney failure, bleeding, stroke
IVUS	Post-PCI IVUS measurements: Stent underexpansion, malapposition, edge dissections, high plaque burden at stent edges, residual focal lesions, stent deformation, tissue protrusion through the stent struts
Angiographic	Angiographic outcomes: Pre-procedural and post-procedural TIMI flow, thrombus burden classification, culprit vessel, number of diseased vessels, angio-graphically evident residual thrombus, no-reflow phenomenon, post-procedural myocardial blush grade, distal embolization, SYNTAX score
Micro-CT	Volume and density of the aspirated thrombi

CABG: Coronary artery bypass graft; IVUS: Intravascular ultrasound; MACE: Major adverse cardiovascular events; Micro-CT: Micro-computed tomography; PCI: Percutaneous coronary intervention; TIMI: Thrombolysis in myocardial infarction; TVF: Target vessel failure.