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e-ULTIMASTER Trial

01/01/2015 -  

Up to 20,000 all-comers patients, single arm, primary endpoint: TLF @ 12M. Ongoing

​Designed to:

  • further validate the safety and efficacy of Ultimaster DES system in unselected patients representing everyday clinical practice
  • assess the impact of non-compliance with dual antiplatelet therapy, one month after stent implantation
    (frequently observed in every day clinical practice), on stent thrombosis

 

Study Design

  • Prospective, single arm, multi-centre, observational registry
  • ~ 17.000 patients suitable to be treated with the Ultimaster DES
  • ~ 200 sites worlwide

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.

Substudies

According to pre-specified criteria patients will be allocated to 1 or more substudies:

ULTIMASTER Acute Coronary Syndrome
ULTIMASTER STEMI
ULTIMASTER NSTEMI
ULTIMASTER Stable Angina

ULTIMASTER Diabetes

  • (IDDM)
  • (NIDDM)

ULTIMASTER Renal Insufficiency

ULTIMASTER Octogenarians
ULTIMASTER Female
ULTIMASTER Female with ACS

ULTIMASTER Small Vessels
ULTIMASTER Long Lesions
ULTIMASTER Restenosis
ULTIMASTER Bifurcation
ULTIMASTER Multivessel Treatment
ULTIMASTER Diabetes with multivessel disease
ULTIMASTER SVG
ULTIMASTER Left Main
ULTIMASTER CTO
ULTIMASTER Imaging guidance

ULTIMASTER Midnight-Midnight (real all-comers population)


Geographic Substudies

In addition to above mentioned sub-studies there will be geographic sub-studies for the main areas:

ULTIMASTER France
ULTIMASTER Germany
ULTIMASTER Nordic
ULTIMASTER Benelux
ULTIMASTER Spain
ULTIMASTER UK
ULTIMASTER Russia
ULTIMASTER Mexico
ULTIMASTER India
ULTIMASTER Japan
ULTIMASTER Europe
ULTIMASTER Central Europe
ULTIMASTER South-East Europe
ULTIMASTER Latin America
ULTIMASTER Asia
ULTIMASTER Middle East


Clinical Follow-up

e-ULTIMASTER - Clinical Follow-up