title: A first-in-man clinical evaluation of Ultimaster, a new drug-eluting coronary stent system: CENTURY study.
abstract: OBJECTIVE
  To report the six-month angiographic and two-year clinical outcome data from the first-in-man study with the Ultimaster DES, a thin-strut cobalt-chromium sirolimus-eluting stent (SES) with an innovative abluminal-gradient-coated bioresorbable polymer.
  
  
  RESULTS
  CENTURY is a multicentre, single-arm, prospective study that enrolled 105 patients (113 lesions) with coronary artery disease. All patients were scheduled to have an angiographic follow-up at six months, while 45 and 20 patients respectively had IVUS and OCT assessments. The primary endpoint was six-month in-stent late lumen loss. Secondary endpoints included clinical, IVUS and OCT outcomes. Clinical follow-up is available up to two years and will continue up to five years. Procedural success was 97.1% and device success was 100%. Angiographic late loss at six months was 0.04±0.35 mm, also reflected in a low binary restenosis rate of 0.9% and confirmed by IVUS-assessed neointimal volume obstruction of 1.02±1.62%. The mean strut coverage assessed by OCT was 96.2% with 1.66±4.02 malapposed stent struts. There were no deaths in the study, three (2.9%) periprocedural and one (0.9%) spontaneous myocardial infarction, not related to the target vessel. At one and two years, the target lesion failure rate was 3.8% and 5.7%, while the TLR rate was 1.9% and 2.8%, respectively. There was one acute definite stent thrombosis.
  
  
  CONCLUSIONS
  The Ultimaster™ novel bioresorbable polymer sirolimus-eluting stent demonstrated good performance, including high procedural success and strong suppression of neointimal proliferation at six months. Good safety and effectiveness were shown up to two years in the studied population.
authors.affiliation: Cardiovascular Center Aalst, Aalst, Belgium.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Barbato
authors.forename: Sonja
authors.initials: S
authors.lastname: Salinger-Martinovic
authors.forename: Dragan
authors.initials: D
authors.lastname: Sagic
authors.forename: Branko
authors.initials: B
authors.lastname: Beleslin
authors.forename: Mathias
authors.initials: M
authors.lastname: Vrolix
authors.forename: Aleksandar N
authors.initials: AN
authors.lastname: Neskovic
authors.forename: Nikola
authors.initials: N
authors.lastname: Jagic
authors.forename: Stefan
authors.initials: S
authors.lastname: Verheye
authors.forename: Zlatko
authors.initials: Z
authors.lastname: Mehmedbegovic
authors.forename: William
authors.initials: W
authors.lastname: Wijns
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D002858:Chromium Alloys; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000175:diagnosis / Q000628:therapy; D058426:Neointima; D062645:Percutaneous Coronary Intervention; D011108:Polymers; D011446:Prospective Studies; D020123:Sirolimus / Q000627:therapeutic use*; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D000903:Antibiotics, Antineoplastic; D002858:Chromium Alloys; D011108:Polymers; D020123:Sirolimus