First-in-man angiographic and OCT single arm assessment

Prospective trial at 8 sites in Europe:

• Primary endpoint: late loss at 6 months
• Main secondary endpoints: TLF (cardiac death, TV-related MI, clinically indicated TLR), and stent thrombosis
• Angio/IVUS: angiographic in-stent and in-segment binary restenosis rate; in-stent, in-segment, proximal, and distal MLD; IVUS-assessed neointimal hyperplasia volume and percentage volume obstruction; OCT-assessed stent strut coverage and malapposition

Stage: Published and completed

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• To investigate the 6-month angiographic and long-term clinical outcomes for Ultimaster

  • Effect on arterial vessel wall assessed with sophisticated imaging techniques: IVUS and OCT
  • Short- and long-term safety and efficacy evaluated by predefined endpoints

• To compare the results for Ultimaster with data from a historical BMS cohort

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.

• Ultimaster was superior to the BMS withrespect to in-stent late loss: achieving a 95% late loss reduction

• IVUS and OCT data support the efficacy and safety profile of Ultimaster:

  • Thin and homogeneous layer of neointima covered stent struts 6 months after implantation
  • Average strut coverage rate of 96.2%

• Rates of clinical events remained low with Ultimaster up to 5 years after implantation, with a low TLR rate, and just one acute ST reported due to untreated dissection

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.