Registry for BioFreedom Ultra drug-coated stent in coronary artery disease patients
BioFreedom Ultra Stent in Hong Kong All Comers Registry
This study is testing how well the BioFreedom Ultra drug-coated stent works for patients with coronary artery disease who are at high risk of bleeding and need a procedure to open their blocked arteries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin, New Territories) |
| Trial ID | NCT05094284 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to evaluate the performance of the BioFreedom Ultra, a thin strut drug-coated stent, in patients undergoing percutaneous coronary intervention (PCI) for coronary artery disease. The study focuses on high-bleeding-risk patients who will receive the stent and be monitored for clinical outcomes. The BioFreedom Ultra stent is designed to improve flexibility and deliverability while reducing the risk of in-stent restenosis, particularly in small vessels. Patients enrolled will be at least 18 years old and have specific indications for PCI.
Who should consider this trial
Good fit: Ideal candidates for this registry are adults aged 18 and older with coronary artery stenosis greater than 50% who require PCI.
Not a fit: Patients who have known intolerance to any components of the stent or those unable to provide informed consent may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the safety and efficacy of the BioFreedom Ultra stent, potentially leading to improved treatment options for patients with coronary artery disease.
How similar studies have performed: Previous studies have shown success with similar thin strut drug-eluting stents, indicating a promising approach in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: This is an "all comers" registry and patient who will be enrolled have to meet following criteria: * Patient must be at least 18 years of age * Patient must have indication to percutaneous coronary intervention including: * Stable angina or evidence of myocardial ischemia with stress echocardiography/ myocardial SPECT/exercise test, or * Unstable angina / non ST-elevation myocardial infarction, OR * ST-elevation myocardial infarction with de novo culprit lesion. * Presence of one or more coronary artery stenosis \>50% with reference diameter 2.0-6.0mm which can be covered by one or multiple stents Exclusion Criteria: * Known intolerance to any of the device components * Inability to provide written informed consent * Participating in other trial before reaching primary endpoint * Planned surgery within 1 month of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period.
Where this trial is running
Shatin, New Territories
- Prince of Wales Hospital — Shatin, New Territories, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Bryan Yan — Chinese University of Hong Kong
- Study coordinator: Daniel Xu
- Email: danielxu@cuhk.edu.hk
- Phone: 35051518
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.