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Ultimaster™ Family Clinical Program

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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. * Follow-up will continue up to 5 years for patients enrolled in Japan.


A remarkable 16 CE marked indications12

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Consistent good safety* data at 1 year from controlled clinical trial4 and routine clinical practice9

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For CENTURY II, patient numbers are from the per-protocal analysis at baseline. p=non-significant, unless otherwise stated.
MI, mycordial infarction; ST, stent thrombosis; TV, target vessel.

*Statements on 'safety are based on cardiac death, MI and ST rates in the referenced study,**data on file


Sustained long-term safety* from controlled clinical trial4

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For CENTURY II, patient numbers are from the per-protocal analysis at baseline. p=non-significant, unless otherwise stated.
MI, mycordial infarction; ST, stent thrombosis; TV, target vessel.
*Statements on 'safety are based on cardiac death, MI and ST rates in the referenced study,**data on file


References:

  1. Stojkovic S et al. Fundam Clin Pharmacol 2014;29:95–105

  2. Barbato E et al. EuroIntervention 2015;11:541–8

  3. Saito S et al. Eur Heart J 2014;35:2021–31

  4. Wijns W et al. EuroIntervention 2018;14:e343–51

  5. Valdes-Chavarri M.EuroIntervention 2019;14:e1836-e1842

  6. Chevalier B et al. Circ Cardiovasc Interv 2017;10:pii:e004801

  7. Saito S et al Cardiovasc Interv Ther 2018;doi: 10.1007/s12928-018-0511-3

  8. e-ULTIMASTER trial. Available at: https://clinicaltrials.gov/ct2/show/NCT02188355

  9. Roffi M. Presented at EuroPCR 2020

  10. MASTER DAPT trial. Available at https://clinicaltrials.gov/ct2/show/NCT03023020

  11. Frigoli E et al. Am Heart Journal. 2018;209:97-105

  12. Ultimaster™ Tansei™ Instructions for Use