BioFreedom Ultra Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-11

Study Completion Date

2028-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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BioFreedom Ultra

this is a registry only

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No