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

Table 1 Summary of inclusion and exclusion criteria for the ULTRA-STEMI trial

Inclusion criteria	Exclusion criteria
Patients with symptoms of myocardial ischemia for at least 30 minutes	Patients who have received thrombolytic therapy for index STEMI event
ECG changes indicating STEMI	Known intolerance to heparin, aspirin or P2Y12 inhibitor therapy (clopidogrel, prasugrel, or ticagrelor)
Minimum reference vessel diameter > 2.5 mm	Cardiogenic shock
	Graft vessel as the culprit vessel
Written informed consent	Presentation ≥ 12 hours after symptom onset

Table 2 Variables collected and assessed in each patient enrolled in the ULTRA-STEMI trial

Data	Pre-intervention	Post-intervention	Post-optimization
IVUS data	Vessel, lumen and plaque cross-sectional area; Minimal lumen area; Plaque area and burden; Calcium severity; Supposed thrombus presence; Thrombus morphology (acute, subacute, organized)	Stent expansion; Plaque burden at stent edges; Edge dissection; Haematoma; Malapposition; Thrombus protrusion through stent struts; Percentage area stenosis	Minimum stent area; Stent underexpansion; Stent malapposition; Stent deformation; Stent edge dissection; Residual disease at stent edge
	Pre-PCI	Post-PCI
Echocardiographic data	LVEF	LVEF
Clinical data	Medical history; electrocardiographic and laboratory data; IIb/IIIa inhibitors/heparin administration	Electrocardiographic and laboratory data; Stent length and diameter; Amount of contrast drug administered; PCI and CA duration; Total effective radiation dose; Total fluoroscopy time; Number and type of stents; Number of catheters used; ST-segment resolution
Micro-CT data		Thrombus volume
	n.a.	Thrombus density
Angiographic data	Pre-procedural TIMI flow; Thrombus burden classification; Culprit vessel; Number of diseased vessels; SYNTAX score	Angiographically evident residual thrombus burden; Myocardial no-reflow phenomenon; Post-procedural TIMI flow; Distal embolization
Follow-up data	n.a.	Mortality (+cause); CV-hospitalization; MI/revascularization(+vessel); Thromboembolic or bleeding event; Peri- and post-procedural complications

CA: Coronary angiography; CV: Cardiovascular; IVUS: Intravascular ultrasound; LVEF: Left ventricular ejection fraction; MI: Myocardial infarction; Micro-CT: Micro-computed tomography; n.a: Not applicable; PCI: Percutaneous coronary intervention; TIMI: Thrombolysis in myocardial infarction.

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.