eUltra 10K
Research type
Research Study
Full title
A Post-Market Registry of the BioFreedom™ Ultra CoCr Biolimus A9™ coated coronary stent system
IRAS ID
321054
Contact name
Stuart Watkins
Contact email
Sponsor organisation
Biosensors Europe S.A.
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 3 months, 14 days
Research summary
Atherosclerosis (disease, in which the heart arteries are narrowed) is a major cause of premature death worldwide and an important source of loss of disability-adjusted life years.
Over the past 15 years, an increasing number of patients with diseased heart arteries have been treated with drug eluting coronary stents (DES) to re-open a narrowed artery and allow blood to flow normally. DES have a polymer coating and take longer to fully heal inside the artery than BMS. As a consequence, patients have to take two blood thinning medications for six to 12 months afterwards, which increases the risk of bleeding for these patients.
The BioFreedom™ Ultra CoCr BA9™ drug coated stent (DCS), is a new type of DES without a polymer coating, which has received CE mark in October 2020 and is commercially available. In patients with high bleeding risk, physicians may choose a 1-month treatment with two blood thinning medications after implantation with this coronary stent.
eUltra 10 K is a prospective, observational multi-center registry, which captures safety and efficacy data on the BioFreedom™ Ultra CoCr BA9™ DCS in standard clinical practice (“real-world” population) and serves as Post Market Clinical Follow up (PMCF) as part of the Post-Market Surveillance.
It is planned to conduct the registry at up to 150 interventional cardiology centers in up to 15 countries in Europe, South America, Middle East and Asia. In the UK up to 20 NHS sites will participate.
This registry will include up to 10,000 patients over a period of 5 years. All patients with coronary artery disease treated by implantation with one or more BioFreedom™ Ultra CoCr DCS within the products indications of the Instructions for Use (IFU) may be included.After stent implantation patients will be followed by telephone for 1 year after PCI for data collection.
REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0823
Date of REC Opinion
18 Jan 2023
REC opinion
Further Information Favourable Opinion