Coronary Artery DiseaseNCT05643430
ULTRA LONG: BioFreedom Ultra
A study testing BioFreedom Ultra in people with Coronary Artery Disease and High Bleeding Risk Patients, run by Biosensors Europe SA at 9 sites in 2 countries.
Trial summary
The goal of this Prospective, multi-center, open-label single-arm study is to Assess the Safety and Effectiveness of additional sizes of the BioFreedom Ultra CoCr Biolimus A9 coated coronary stent system in Patients at high risk of bleeding (HBR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, High Bleeding Risk Patients
- What is being tested?
- BioFreedom Ultra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 27 Feb 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pregnant and breastfeeding women
- Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent
- Patients not expected to comply with 1 month of DAPT
- Staged procedures in the target vessel
- Active bleeding at the time of inclusion
- Cardiogenic shock
Show all 10Show fewer
- Unlikely compliance with long-term single anti-platelet therapy
- Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated
- Currently participating in another trial before reaching primary endpoint
- Patients under judicial protection, tutorship or curatorship (France only)
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United Kingdom6 sites
University Hospitals Birmingham (UHB)
Birmingham, B15 2TH
Royal Blackburn Hospital
Blackburn, BB2 3HH
Hull University Teaching Hospitals (HUTH)
Hull, HU3 2JZ
United Lincolnshire Hospitals (ULH)
Lincoln
The Grange University Hospital, Newport
Newport, NP44 8YN
Royal Albert Edward Infirmary
Wigan, WN1 2NN
France3 sites
Pôle Santé République
Clermont-Ferrand, 63050
Cardiovascular Institute Paris Sud (ICPS) L'Hôpital Privé Jacques Cartier
Massy, Massy, 91300
Arnault Institute Tzanck
Saint-Laurent-du-Var, Saint-Laurent-du-Var, 06700
About this study
Official title: A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of Additional Sizes of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System
The goal of this Prospective, multi-center, open-label single-arm study is to Assess the Safety and Effectiveness of additional sizes of the BioFreedom Ultra CoCr Biolimus A9 coated coronary stent system in Patients at high risk of bleeding (HBR). The main question it aims to answer is to evaluate if the additional sizes of the BioFreedom Ultra have corresponding clinical safety and efficacy characteristics as the regulatory approved (=CE Marked) sizes.
- Being tested
- BioFreedom Ultra
- Keywords
- BioFreedom Ultra
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioFreedom UltraDevice
The BioFreedom Ultra CoCr DCS is a combination product consisting of two key components: the cobalt chromium stent platform coated abluminally with the active ingredient BA9TM (polymer and carrier free) and the delivery system.
| Study group | Role | What they receive |
|---|---|---|
| BioFreedom Ultra | Experimental | All patients will receive the BioFreedom Ultra as per treatment. Receives: Device: BioFreedom Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
TLF
Incidence of Target Lesion Failure, clinically-driven target lesion revascularization (cd-TLR), Cardiovascular Death and TV-MI
Measured: at 9 months after index procedure
Secondary outcomes (8)
CD-TLR
Incidence of Clinically driven Target Lesion Revascularization
Measured: Clinical endpoints measured at 9 and 24 months
Cardiovascular Death
Incidence
Measured: Clinical endpoints measured at 9 and 24 months
TV-MI
Target-Vessel Myocardial Infarction
Measured: Clinical endpoints measured at 9 and 24 months
TVR
Target Vessel Revascularization
Measured: Clinical endpoints measured at 9 and 24 months
Stent thrombosis rate - definite/probable
Incidence
Measured: Clinical endpoints measured at 9 and 24 months
All cause mortality
Incidence
Measured: Clinical endpoints measured at 9 and 24 months
Bleeding rate (BARC 2-5)
Incidence of BARC 2-5
Measured: Clinical endpoints measured at 9 and 24 months
Peri-procedural endpoints
Incidence of Device success; Lesion success and Procedure success
Measured: Peri-procedural endpoints measured at 9 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start27 Feb 2024
- Primary completion8 Mar 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multi-center, open-label single-arm study
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biosensors Europe SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Garot, Professor, Principal investigator, Cardiovascular Institute Paris Sud (ICPS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643430
- Sponsor's protocol ID
- 22-EU-02
- Status last verified
- Jun 2025
- First submitted
- 28 Oct 2022
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of Additional Sizes of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System
- ClinicalTrials.gov ID
- NCT05643430
- Acronym / sponsor ID
- 22-EU-02
- Keywords
- BioFreedom Ultra
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Biosensors Europe SAIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 8 Mar 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this Prospective, multi-center, open-label single-arm study is to Assess the Safety and Effectiveness of additional sizes of the BioFreedom Ultra CoCr Biolimus A9 coated coronary stent system in Patients at high risk of bleeding (HBR). The main question it aims to answer is to evaluate if the additional sizes of the BioFreedom Ultra have corresponding clinical safety and efficacy characteristics as the regulatory approved (=CE Marked) sizes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multi-center, open-label single-arm study
| Arm | Type | Receives |
|---|---|---|
| BioFreedom Ultra | Experimental | Device: BioFreedom UltraAll patients will receive the BioFreedom Ultra as per treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Pregnant and breastfeeding women
- Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent
- Patients not expected to comply with 1 month of DAPT
- Staged procedures in the target vessel
- Active bleeding at the time of inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioFreedom UltraThe BioFreedom Ultra CoCr DCS is a combination product consisting of two key components: the cobalt chromium stent platform coated abluminally with the active ingredient BA9TM (polymer and carrier free) and the delivery system. | Device | BioFreedom Ultra |
Primary outcome
TLF
Time frame: at 9 months after index procedure
Incidence of Target Lesion Failure, clinically-driven target lesion revascularization (cd-TLR), Cardiovascular Death and TV-MI
8 secondary outcomes
CD-TLR
Time frame: Clinical endpoints measured at 9 and 24 months
Cardiovascular Death
Time frame: Clinical endpoints measured at 9 and 24 months
TV-MI
Time frame: Clinical endpoints measured at 9 and 24 months
TVR
Time frame: Clinical endpoints measured at 9 and 24 months
Stent thrombosis rate - definite/probable
Time frame: Clinical endpoints measured at 9 and 24 months
All cause mortality
Time frame: Clinical endpoints measured at 9 and 24 months
Bleeding rate (BARC 2-5)
Time frame: Clinical endpoints measured at 9 and 24 months
Peri-procedural endpoints
Time frame: Peri-procedural endpoints measured at 9 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Garot, Professor principal investigator
Cardiovascular Institute Paris Sud (ICPS)
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioFreedom Ultra in people with Coronary Artery Disease and High Bleeding Risk Patients, run by Biosensors Europe SA at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TLF (time frame: at 9 months after index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.