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Ultimaster Clinical Program

07/09/2018 - Global

A comprehensive clinical program

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Assessment of ‘safety’ refers to the side-effect profile and clinical events experienced (eg stroke, myocardial infarction, unplanned revascularisation). BMS, bare-metal stent; DAPT, dual antiplatelet therapy; MACCE, major adverse cardiac and cerebral events; MACE, major adverse coronary events; MCB, major or clinically relevant non-major bleeding; NACE, net adverse clinical endpoints; OFDI, optical frequency domain imaging; PCI, percutaneous coronary intervention; STEMI, ST-segment elevation myocardial infarction; TLF, target lesion failure. 


A remarkable 16 CE marked indications

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Data on file: Ultimaster clinical data for specific indications, Annex to PS-6079, Clinical evaluation report, prepared November 2016; Data on file at Terumo Europe 


Consistent good safety* data at 1 year from controlled clinical trials12 and routine clinical practice13

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Sustained long-term safety from controlled clinical trials14

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References:

  1. Stojkovic S et al. Fundam Clin Pharmacol 2014;29:95–105; 
  2. Barbato E et al. EuroIntervention 2015;11:541–8; 
  3. Beleslin B. Presented at EuroPCR 2017, abstract OP0028; 
  4. Saito S et al. Eur Heart J 2014;35:2021–31; 
  5. Data on file at Terumo Europe; 
  6. Valdes-Chavarri M. Presented at PCR 2016; 
  7. Chevalier B et al. Circ Cardiovasc Interv 2017;10:pii:e004801:doi:10.1161/CIRCINTERVENTIONS.116.004801; 
  8. Saito S et al Cardiovasc Interv Ther 2018;doi: 10.1007/s12928-018-0511-3; 
  9. e-ULTIMASTER trial. Available at: https://clinicaltrials.gov/ct2/show/NCT02188355?term=e-ULTIMASTER&rank=1 (accessed July2018); 
  10. Polad J. Presented at PCR2017, abstract POS0688; 
  11. MASTER DAPT trial. Available at https://clinicaltrials.gov/ct2/show/NCT03023020?term=master+dapt&rank=1 (accessed July 2018).
  12. Internal report ISCD-523-37-20 - Report-CEII-1year results
  13. Internal report ISCD-523-37-19 - Report-eUM-Interim analysis
  14. Saito et al. - Presented at EuroPCR2018