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MASTER Trial

01/01/2015 -  

500 STEMI patients, randomised 1:3 vs Kaname BMS, primary endpoint TVF 12M. Ongoing.

Designed to:

  • confirm safety and efficacy of Ultimaster drug eluting stent used in STEMI patients by proving superiority in efficacy and non-inferiority in safety versus bare metal stent
  • generate further evidence for benefits of primary PCI with DES in patients with STEMI
  • generate further evidence for benefits of bioresorbable polymer

 

Study Design

  • randomized (3:1) Ultimaster vs Kaname, single blind
  • 500 patients with acute STEMI
  • 16 sites
  • 5 countries
  • Triple primary endpoint at 1 (safety), 6 (efficacy) and 12 months (safety/efficacy)
  • Secondary endpoints: clinical, procedural, device related, angiographic...


Triple primary endpoint

MASTER - Triple primary endpoint
  • Safety at 1 month:
    composite of all-cause death, recurrent MI, unplanned infarct related artery revascularization, stroke,
    definite stent thrombosis or major bleeding
  • Efficacy at 6 months:
    In-stent late loss in a subset of 100 patients
  • Safety/efficacy at 12 months:
    Target Vessel Failure (TVF), a composite endpoint (cardiac death and MI not clearly attributable to a non-target vessel and clinically driven Target Vessel Revascularisation)

Clinical Follow-up