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e-ULTIMASTER Trial

22/05/2019 -  

One of the largest, prospective worldwide registries



Designed to:

  • Further validate the safety and efficacy of Ultimaster™ family DES system in unselected patients representing everyday clinical practice

  • Further explore the performance of Ultimaster™ family DES in large complex patient and lesions subsets


Study Design

Prospective, single arm, multi-centre, observational registry

  • 37.000+ patients

  • 376 sites

  • 50 countries

Primary Outcome Measure:

Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related Myocardial Infarction (MI) 

and clinically driven Target Lesion Revascularization (TLR) at 1 year.

Clinical follow-up



Total Population

In 25,000+ patients, e-Ultimaster shows 1-year target lesion failure rate of 3.3%.


Primary endpoint: target lesion failure at 1 year

Cardiac death, target-vessel myocardial infarction or clinically-driven target lesion revascularization
n=25'990



Total population

Roffi, M., presented at euroPCR2019


Bifurcation Lesions

Reporting a low target lesion failure rate of 5.2% at 1 year in bifurcation lesions.

1-year clinical outcomes
Bifurcation, n=3'372 patients 

bifurcation lesions

CD-TLR: clinically driven target lesion revascularization; CD-TVR: clinically driven target vessel revascularization; MI: myocardial infarction; ST: definite+probable stent thrombosis; TLF: target lesion failure (a composite of cardiac death, target-vessel MI or CD-TLR)

Chevalier B., presented at euroPCR2019


Left Main

Providing a safe and good option for the treatment of left main lesions 

1-year clinical outcomes
Left main, n=840 patients 

Left Main

LM: left main; MI: myocardial infarction; ST: definite + probable stent thrombosis; TLF: target lesion failure (a composite of cardiac death, target-vessel MI or clinically-driven TLR); TLR: target lesion revascularization; TVF: target vessel failure (composite of cardiac death, target-vessel MI or clinically-driven target-vessel revascularization);

Angioi M.; presented at euroPCR2019

 

CTO 

Real-world good clinical outcomes in complex CTO patients.

1-year clinical outcomes
Chronic total occlusion, n=1309

CTO

CD-TLR: clinically-driven target lesion revascularization; MI: myocardial infarction; ST: definite + probable stent thrombosis; TLF: target lesion failure (composite of cardiac death, target vessel MI and CD-TLR); TVF: target vessel failure (composite of cardiac death, target vessel MI and clinically-driven target vessel revascularization

Rumoroso J.; presented at euroPCR2019


Multivessel Disease

Complete revascularization results in good clinical outcomes in all MVD patients and STEMI MVD patients

Multivessel disease 1
Multivessel disease 2


CD-TLR: clinically-driven target lesion revascularization; MI: myocardial infarction; POCE: patient-oriented composite endpoint ( a composite of all-cause mortality, any MI, any revascularization); ST: definite + probable stent thrombosis; STEMI: ST-elevated myocardial infarction; TLF: target lesion failure (a composite of cardiac death, TV-MI and clinically driven target lesion revascularization)

Hildick-Smith D., presented at euroPCR2019