The Power of n
Do you believe in the Power of n? The Ultimaster™ clinical program included more than 50,000 patients covering 16 CE marked indications.
The Ultimaster™ Clinical Program
The Ultimaster™ clinical program included more than 50,000 patients covering 16 CE marked indications.1-3
Complex PCI: n=10,241 patients
Demonstrates favorable outcomes in both complex and non-complex PCI patients.
Bifurcation : n=4,395 patients
Demonstrates proximal optimization technique (POT) is associated with improved outcomes.
MVD : n=15,441 patients
Suggests that complete revascularization is associated with better outcomes versus incomplete revascularization.
Abbreviated DAPT. Groundbreaking results
MASTER DAPT is the largest, multi-center randomized controlled study on the use of abbreviated dual antiplatelet therapy (DAPT) in high bleeding risk patients.
A total cohort of 4,579 patients have been randomized into this ambitious study, designed to prove the efficacy and safety of Ultimaster™ and Ultimaster™ Tansei™ stents in a short DAPT strategy.
The results are groundbreaking. The MASTER DAPT study shows short DAPT to be noninferior to standard therapy of at least two months, with regard to net and major adverse clinical events. It also shows short DAPT to be superior to standard DAPT for major or clinically relevant non-major bleeding.4
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Data driving your clinical decisions
The Ultimaster™ clinical program included one of the largest, prospective worldwide registries, the e-ULTIMASTER™ with 37,198 patients.5 The Ultimaster™ clinical program2 demonstrates the safe and effective use of the Ultimaster™ stent in different patient cohorts, representative of daily PCI practice.
| Total Population |
|
| Complex PCI |
|
| Bifurcation |
|
| Multivessel Disease |
|
The most studied BP-DES,Over 50,000 patients world wide¹′²
The Ultimaster™ has been studied worldwide by enrolling over 50,000 patients in Terumo sponsored trial and investigator sponsored research. The clinical programs have consistently shown favorable efficacy and safety of the Ultimaster™ even in complex lesions.
| Number of patients | Design | Primary outcomes | Sub Study | |
|---|---|---|---|---|
| MASTER DAPT | 4,300 |
Investigator-initiated Randomised Short vs standard DAPT |
NACE MACCE MCB at 11 months (12 months post-index PCI) |
OAC |
| e-Ultimaster | 37,198 |
Single arm All-comers Real-world use |
TLF at 1 year | Bifurcation Left Main |
| CENTURY II | 1,123 | Randomised 1:1 vs Xience | Freedom from TLF at 9 months | Bifurcation Multivessel disease |
| DISCOVERY 1TO3 | 60 |
Single arm Patients with multivessel disease |
OFDI strut coverage at 3 months | |
| MODEL U-SES | 1,695 | Prospective multicenter single-arm registry, Investigators initiated study | Composite endpoint of all-cause death, MI, stroke, ARC definite / probable stent thrombosis, and BARC 3 or 5 during 12months after stenting | |
| SCAAR | 3,253 | Multicenter registry in Sweden |
ST Restenosis rate |
|
| SCC registry | 1,727 |
Single arm All-comers Single center study |
TLR TLF MACE |
|
| ULISS | 1,660 |
Single arm All-comers Multi-center study |
TLF TLR Composite endpoint of cardiac death, TV-MI |
|
| MASTER | 500 | Randomised 3:1 vs BMS in patients with STEMI |
Safety at 1 month Efficacy at 6 months Safety and efficacy at 12 months |
|
| COLOR | 388 |
Investigator-initiated Randomised complexed large-bore radial PCI trial |
BARC bleeding or vascular complication related to access site | |
| CENTURY | 105 |
Single arm First-in-man study |
Late loss at 6 months | |
| CENTURY JSV | 70 |
Single arm Patients requiring 2.25 mm diameter stents |
Freedom from MACE at 9 months | |
| TCD-10023PK | 22 |
Single arm Pharmaco kinetics |
Sirolimus concentration in peripheral blood samples 28 days after Ultimaster implantation |
Video
The Summary on the Power of n
Three experts guide you to understand the power of the big data and how large registry data can impact your practice.
Ultimaster™ Tansei™
Building on the heritage of the original Ultimaster™ stent, the updated design of the Ultimaster™ Tansei™ brings you enhanced pushability and excellent kink resistance to maximize deliverability. Find out how the Ultimaster™ Tansei™ can help you master complexity with confidence.
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Ultimaster™
Terumo’s proprietary bioresorbable polymer coating and two-link design help facilitate smoother access. Discover how the Ultimaster™ stent can ensure optimal deliverability and potentially shortened DAPT time.
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