BioFreedom Ultra Registry

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT05094284
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-11
• Study First Submitted: 2021-10-17
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-10-26
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-22
• Primary Completion: 2028-04
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACE events	12 months post index procedure	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.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, New Territories, Hong Kong