BioFreedom Ultra Registry

Coronary Artery Disease Clinical Trial

Official title:

BioFreedom Ultra Stent in Hong Kong All Comers Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05094284
• Other study ID #: 2021.459
• Status: Recruiting
• Start date: October 11, 2021
• Est. completion date: July 2028

Study information

• Verified date: September 2022
• Source: Chinese University of Hong Kong
• Contact: Daniel Xu
• Phone: 35051518
• Email: danielxu[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2028
• Est. primary completion date: April 2028
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• BioFreedom Ultra
this is a registry only

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (4)

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 — View Citation

Garot P, Morice MC, Tresukosol D, Pocock SJ, Meredith IT, Abizaid A, Carrié D, Naber C, Iñiguez 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, Windhövel U, Greene S, Sto — View Citation

Sabaté M, Okkels Jensen L, Tilsted HH, Moreno R, García Del Blanco B, Macaya C, Pérez de Prado A, Cequier À, Pérez-Fuentes P, Schütte 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. — View Citation

Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrié D, Naber C, Lipiecki J, Richardt G, Iñiguez 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE events	12-months cumulative hierarchical incidence of major adverse cardiac events (MACE) defined as: cardiac death, non-fatal myocardial infarction (MI) and clinically indicated target vessel revascularization (TVR). In order to minimize bias in assessing MACE outcomes, these events will be adjudicated by an independent observer.	12 months post index procedure