Registry for BioFreedom Ultra in real-world clinical practice
Official title: A Post-Market Registry of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System
Run by Biosensors Europe SA · NCT05505929 · Data updated 2026-11-12
This study is collecting information from up to 10,000 patients who receive the BioFreedom Ultra drug-coated stent to see how well it works and keeps people safe in everyday medical practice.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | Biosensors Europe SA Industry-sponsored |
| Locations | 10 sites (Eisenstadt and 9 other locations) |
| Status | Recruiting |
| Started | June 15, 2023 |
| Main results expected | December 31, 2028 |
| Study ends | March 30, 2029 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT05505929 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this registry are patients aged 18 and older who are undergoing PCI and meet the inclusion criteria as per the Instructions for Use.
✕Probably not a fit
Patients who are minors, pregnant or breastfeeding, or those under judicial protection will not benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational registry aims to collect data on the BioFreedom Ultra CoCr Drug-Coated Stent (DCS) used in standard clinical practice across various interventional cardiology centers. Conducted in up to 150 centers across 15 countries, the study will enroll up to 10,000 patients who will be followed for one year post-percutaneous coronary intervention (PCI) through telephone or clinic visits. The registry serves as a Post Market Clinical Follow up (PMCF) to ensure ongoing safety and effectiveness of the device in a real-world population.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the long-term safety and effectiveness of the BioFreedom Ultra stent, potentially improving patient outcomes in interventional cardiology.
How similar studies have gone: Other observational registries have successfully provided critical data on drug-coated stents, indicating that this approach is supported by previous findings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * According to the current version of Instructions of Use (IFU) * Patient is at least 18 years old * Patient provides a signed informed consent Exclusion Criteria: * 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
Where it's running
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Krankenhaus Barmherzige Brüder
Eisenstadt, Austria Recruiting -
Clinique Des Domes Psr
Clermont-Ferrand, France Recruiting -
Klinikum Lippe
Detmold, Germany Recruiting -
Hospital Marques Valdecilla
Santander, Spain Recruiting -
University and Hospital Fribourg
Fribourg, Switzerland Recruiting -
Universitäres Herzzentrum
Zurich, Switzerland Recruiting
Show 4 more locations
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Military hospital
Tunis, Tunisia Recruiting -
Al Qassimi Hospital
Sharjah city, United Arab Emirates Recruiting -
Royal Bournemouth hospital
Bournemouth, United Kingdom Recruiting -
Golden Jubilee National Hospital
Glasgow, United Kingdom Recruiting
Study contacts
- Study coordinator: Calvin Bahr, MS
- Email: c.bahr@biosensors.com
- Phone: +41 21 804 80 24
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.