Post Market Clinical Follow up (PMCF)NCT05505929
eUltra 10k - Biofreedom Ultra
An observational study of Post Market Clinical Follow up (PMCF), run by Biosensors Europe SA at 10 sites in 8 countries.
Trial summary
This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post Market Clinical Follow up (PMCF) as part of the Post-Market Surveillance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Market Clinical Follow up (PMCF)
- What is being tested?
- Biofreedom Ultra
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 10 sitesin 8 countries
- Study dates
- 15 Jun 2023to 30 Mar 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: This observational registry is open to all patients with coronary artery disease treated by percutaneous coronary intervention (PCI) with one or more BioFreedom™ Ultra CoCr DCS within the products indications of the Instructions for Use (IFU).
Who may be able to join
- According to the current version of Instructions of Use (IFU)
- Patient is at least 18 years old
- Patient provides a signed informed consent
Who cannot join
- According to current version of IFU
- Patients will be excluded as per Medical Device Regulation (MDR) (Article 65: "Clinical investigations on minors" and article 66: "Clinical investigations on pregnant or breastfeeding women"
- Patients will be excluded if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision
Trial locations and contacts
10 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 8 countries
Switzerland2 sites, 2 recruiting
- Recruiting
University and Hospital Fribourg
Fribourg
Stéphane Cook, Prof
- Recruiting
Universitäres Herzzentrum
Zurich
Barbara Stähli, Prof
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Bournemouth hospital
Bournemouth
Peter O'Kane, MD
- Recruiting
Golden Jubilee National Hospital
Glasgow
Stuart Watkins, MD
Austria1 site, 1 recruiting
- Recruiting
Krankenhaus Barmherzige Brüder
Eisenstadt
Rudolf Berger, Prof.
France1 site, 1 recruiting
- Recruiting
Clinique Des Domes Psr
Clermont-Ferrand
Janusz Lipiecki, MD
Germany1 site, 1 recruiting
- Recruiting
Klinikum Lippe
Detmold
Stephan Gielen, Prof
Spain1 site, 1 recruiting
- Recruiting
Hospital Marques Valdecilla
Santander
José Maria de La Torre Hernández, MD
Tunisia1 site, 1 recruiting
- Recruiting
Military hospital
Tunis
Nahdem Hajlaoui, Prof
United Arab Emirates1 site, 1 recruiting
- Recruiting
Al Qassimi Hospital
Sharjah city
Arif Al Nooryani, MD
About this study
Official title: A Post-Market Registry of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System
This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post Market Clinical Follow up (PMCF) as part of the Post-Market Surveillance.
Read the detailed description
Prospective, observational multi-center registry to be conducted at up to 150 interventional cardiology centers in up to 15 countries. Patients will be followed by telephone for 1 year after PCI for data collection. This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post-Market Surveillance.
This registry will enroll up to 10000 patients in up to 150 investigative centers in Europe, South America, Middle East, Asia over a period of 5 years. Each patient be followed with phone (or clinic) visit at 12 months.
- Conditions
- Post Market Clinical Follow up (PMCF)
- Being tested
- Biofreedom Ultra
- Keywords
- PMCF, Registry, Biofreedom Ultra, eUltra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofreedom UltraDevice
The BioFreedomTM 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)
Measured: 12 months
Secondary outcomes (5)
Clinically driven Target Lesion Revascularization (TLR)
Measured: 12 months
Cardiovascular death (CD)
Measured: 12 months
Target Vessel MI
Measured: 12 months
Target Vessel Revascularization (TVR)
Measured: 12 months
Stent thrombosis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start15 Jun 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Market Clinical Follow up (PMCF)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Biosensors Europe SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505929
- Sponsor's protocol ID
- 22-EU-01
- Status last verified
- Mar 2026
- First submitted
- 16 Aug 2022
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Registry of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System
- ClinicalTrials.gov ID
- NCT05505929
- Acronym / sponsor ID
- 22-EU-01
- Conditions
- Post Market Clinical Follow up (PMCF)
- Keywords
- PMCF, Registry, Biofreedom Ultra, eUltra
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Biosensors Europe SAIndustry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 18 Aug 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.
This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post Market Clinical Follow up (PMCF) as part of the Post-Market Surveillance.
Detailed description
Prospective, observational multi-center registry to be conducted at up to 150 interventional cardiology centers in up to 15 countries. Patients will be followed by telephone for 1 year after PCI for data collection. This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post-Market Surveillance.
This registry will enroll up to 10000 patients in up to 150 investigative centers in Europe, South America, Middle East, Asia over a period of 5 years. Each patient be followed with phone (or clinic) visit at 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This observational registry is open to all patients with coronary artery disease treated by percutaneous coronary intervention (PCI) with one or more BioFreedom™ Ultra CoCr DCS within the products indications of the Instructions for Use (IFU).
Key inclusion criteria (3 listed)
- According to the current version of Instructions of Use (IFU)
- Patient is at least 18 years old
- Patient provides a signed informed consent
Key exclusion criteria (3 listed)
- According to current version of IFU
- Patients will be excluded as per Medical Device Regulation (MDR) (Article 65: "Clinical investigations on minors" and article 66: "Clinical investigations on pregnant or breastfeeding women"
- Patients will be excluded if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision
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 BioFreedomTM 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 | – |
Primary outcome
Target Lesion Failure (TLF)
Time frame: 12 months
5 secondary outcomes
Clinically driven Target Lesion Revascularization (TLR)
Time frame: 12 months
Cardiovascular death (CD)
Time frame: 12 months
Target Vessel MI
Time frame: 12 months
Target Vessel Revascularization (TVR)
Time frame: 12 months
Stent thrombosis
Time frame: 12 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 4 Mar 2026.
- 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.
10 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Market Clinical Follow up (PMCF), run by Biosensors Europe SA at 10 sites in 8 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Switzerland, United Kingdom, Austria, France, Germany and 3 more countries. 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?
Contact Calvin Bahr, MS (+41 21 804 80 24, c.bahr@biosensors.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) (time frame: 12 months). 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 4 Mar 2026.