Registry for BioFreedom Ultra in real-world clinical practice
A Post-Market Registry of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System
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 |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biosensors Europe SA Industry-sponsored |
| Locations | 10 sites (Eisenstadt and 9 other locations) |
| Trial ID | NCT05505929 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are minors, pregnant or breastfeeding, or those under judicial protection will not benefit from this registry.
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 performed: Other observational registries have successfully provided critical data on drug-coated stents, indicating that this approach is supported by previous findings.
Eligibility criteria
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 this trial is running
Eisenstadt and 9 other locations
- 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)
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.