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Ultimaster™ Family Clinical Program

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


A remarkable 16 CE marked indications



 


Consistent good safety* data at 1 year from controlled clinical trial4 and routine clinical practice8

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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 et al. EuroIntervention 2019;14:e1836-42;
  6. Chevalier B et al. Circ Cardiovasc Interv 2017;10:pii:e004801;
  7. Mohamed et al. EuroIntervention 2020;16:603-612
  8. Roffi M. Presented at PCR e-course 2020;
  9. MASTER DAPT trial. Available at https://clinicaltrials.gov/ct2/show/NCT03023020; 
  10. Frigoli E et al. Am Heart J 2019;209:97-105
  11. Model U-SES trial. Available at https://clinicaltrials.gov/ct2/show/NCT02837003;
  12. Kozuma K et al. Circ J 2020;85:19-26