An observational study in Coronary Artery Disease, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-22.
Sponsored by Chinese University of Hong Kong · Observational
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.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's planned enrollment of 300 is below the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Chinese University of Hong Kong is the lead sponsor of 1,446 studies on the registry; 467 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Being an observational registry aiming to quantify effect estimates without direct comparisons to other devices, we used confidence interval profiling for sample size justification. Assuming an 8.43% MACE rate at 1 year [5], 95% confidence intervals computed with the adjusted Wald method would be 5.4% to 11.5% for a 300 patient sample. Given that the registry aims to reflect real-world patients and practice, 300 patients will be enrolled in this registry.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
This is an "all comers" registry and patient who will be enrolled have to meet following criteria:
Patient must have indication to percutaneous coronary intervention including:
Exclusion Criteria:
this is a registry only
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.
Time frame: 12 months post index procedure
Plan to share: No
Started Oct 2021 (actual). Primary completion is estimated for Apr 2028, 78 months after the start.
Of 726 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 78 months is above that.
Counting every sponsor, half of 857 studies reached it within 43 months; a quarter within 22 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
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Chinese University of Hong Kong →