First-in-man angiographic and OCT single arm assessment
Prospective trial at 8 sites in Europe:
Stage: Published and completed
IVUS, intravascular ultrasound; OCT, optical coherence tomography MI, myocardial infarction; MLD, minimal lumen diameter; TLR, target lesion revascularisation; TV, target vessel.Barbato E et al. EuroIntervention 2015;11:541–8.Beleslin B. Presented at EuroPCR 2017, abstract OP0028.
*DAPT duration is counted from the day of the last implanted stent; staging has to be pre-specified at the time of screening and cannot be planned later than
2 months after index PCI. †Patients receiving OAC can stop DAPT 2 months after confirmed randomisation.ASA, acetylsalicylic acid; DAPT, dual antiplatelet therapy; MACCE, major adverse cardiac and cerebral events; MCB, major or clinically relevant non-major bleeding;
MI, myocardial infarction; NACE, net adverse clinical endpoints; OAC, oral anticoagulant therapy; PCI, percutaneous coronary intervention; SAPT, single antiplatelet therapy.
Terumo. Ultimaster Drug Eluting Stent Instructions for Use, version 0.1-2018; MASTER DAPT trial. Available at https://clinicaltrials.gov/ct2/show/NCT03023020?term=master+dapt&rank=1 (accessed April 2018).
CI, confidence interval.Kaname used as the BMS platform.
Hypothesis: based on estimated Kaname late loss: 0.90±0.50 mm, late loss of 0.40 mm (0.90–0.50 mm) is considered upper limit for
CENTURY study.Barbato E et al. EuroIntervention 2015;11:541–8.
*Mean±SD. Barbato E et al. EuroIntervention 2015;11:541–8;
Barbato E. Presented at EuroPCR 2015, abstract OP047
Ultimaster vs BMS, propensity matched analysis; Kaname used as the BMS platform.*One acute stent thrombosis due to untreated dissection.
CD-TLR, clinically driven target lesion revascularisation; CD-TVR, clinically driven target vessel revascularisation; ST, stent thrombosis.Beleslin B. Presented at EuroPCR 2017, abstract OP0028.
*Composite of cardiac death, target vessel-related MI and CD-TVR.Kaname used as the BMS platform.Beleslin B. Presented at EuroPCR 2017, abstract OP0028.
Barbato E. Presented at EuroPCR 2015, abstract OP047; Barbato E et al. EuroIntervention 2015;11:541–8; Beleslin B. Presented at EuroPCR 2017, abstract OP0028.