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Recruiting NCT05094284

BioFreedom Ultra Registry

— Observational Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BioFreedom Ultra.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

BioFreedom Ultra Stent in Hong Kong All Comers Registry

Overview

Over the past three decades, coronary stent struts have been made progressively thinner. Thin strut drug-eluting stents (DES) performed better than their thicker counterparts in a recent study. Thinner struts discourage abnormal coronary flow after implantation and associated with greater flexibility, deliverability and better clinical outcomes. Lower strut thickness may be particularly advantageous in small target vessels because thicker struts and smaller minimum in-stent lumen diameter are independent predictors of in-stent restenosis. BioFreedom Ultra is a thin strut (84μm), cobalt-chromium, carrier-free drug-coated stent with Biolimus A9 drug. The BioFreedom Ultra stent is intended for percutaneous coronary intervention (PCI) for high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy. BioFreedom Ultra received CE mark in October 2020 supported by the LEADERS FREE III trial which enrolled 400 HBR patients using the same inclusion criteria as the LEADERS FREE randomized trial. LEADERS FREE III is a single-arm trial, with all patients treated using the BioFreedom Ultra stent. The data was compared to the BioFreedom stainless steel drug-coated stent (DCS-StS) and bare-metal stent (BMS) groups from LEADERS FREE. The primary safety endpoint of the trial was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization. The study found that the BioFreedom Ultra was non-inferior to the DCS-StS for safety and superior to the BMS for efficacy. Definite or probable stent thrombosis at 1 year in this HBR population was only 1%. Recently, the Biofreedom QCA randomized trial compared the Biofreedom Ultra with the stainless steel version (DCS-StS) in an all-comer population. In this prospective, single-blind non-inferiority randomized (1:1) trial, BioFreedom Ultra was non-inferiority for late lumen loss at 9 months in comparison with DCS-StS.

Interventions

  • Device BioFreedom Ultra
    this is a registry only

Primary outcome measures

  • MACE events [Time frame: 12 months post index procedure]

Eligibility criteria

Inclusion criteria

This is an "all comers" registry and patient who will be enrolled have to meet following criteria:

  • Patient must be at least 18 years of age
  • Patient must have indication to percutaneous coronary intervention including:
  • Stable angina or evidence of myocardial ischemia with stress echocardiography/ myocardial SPECT/exercise test, or
  • Unstable angina / non ST-elevation myocardial infarction, OR
  • ST-elevation myocardial infarction with de novo culprit lesion.
  • Presence of one or more coronary artery stenosis >50% with reference diameter 2.0-6.0mm which can be covered by one or multiple stents

Exclusion criteria

  • Known intolerance to any of the device components
  • Inability to provide written informed consent
  • Participating in other trial before reaching primary endpoint
  • Planned surgery within 1 month of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Hong Kong · 1 center
  • Prince of Wales Hospital — Shatin

Publications

  • Sabate M, Okkels Jensen L, Tilsted HH, Moreno R, Garcia Del Blanco B, Macaya C, Perez de Prado A, Cequier A, Perez-Fuentes P, Schutte D, Costa RA, Stoll HP, Flensted Lassen J. Thin- versus thick-strut polymer-free biolimus-eluting stents: the BioFreedom QCA randomised trial. EuroIntervention. 2021 Jun 25;17(3):233-239. doi: 10.4244/EIJ-D-20-01162. PMID 33433389
  • Buiten RA, Ploumen EH, Zocca P, Doggen CJM, van der Heijden LC, Kok MM, Danse PW, Schotborgh CE, Scholte M, de Man FHAF, Linssen GCM, von Birgelen C. Outcomes in Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels: A Prespecified Analysis of the Randomized BIO-RESORT Trial. JAMA Cardiol. 2019 Jul 1;4(7):659-669. doi: 10.1001/jamacardi PMID 31111862
  • Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrie D, Naber C, Lipiecki J, Richardt G, Iniguez A, Brunel P, Valdes-Chavarri M, Garot P, Talwar S, Berland J, Abdellaoui M, Eberli F, Oldroyd K, Zambahari R, Gregson J, Greene S, Stoll HP, Morice MC; LEADERS FREE Investigators. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. N Engl J Med. 2015 Nov 19;373(21):2038-47. doi: 1 PMID 26466021
  • Garot P, Morice MC, Tresukosol D, Pocock SJ, Meredith IT, Abizaid A, Carrie D, Naber C, Iniguez A, Talwar S, Menown IBA, Christiansen EH, Gregson J, Copt S, Hovasse T, Lurz P, Maillard L, Krackhardt F, Ong P, Byrne J, Redwood S, Windhovel U, Greene S, Stoll HP, Urban P; LEADERS FREE Investigators. 2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents. J Am Coll Cardi PMID 27806919

Identifiers

NCT: NCT05094284 · 2021.459

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗