REgistry of Paclitaxel Coated Drug Eluting Balloon in All Comers PaTients
NCT06899555 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2025-03-28
Summary
A post marketing, observational , multi centre, prospective registry to assess safety and performance of the Drug Eluting Balloon in patients undergoing percutaneous coronary intervention.
Rational : Although DEBs are generally considered safe, there remain many unanswered questions about DEB technology in a real-world population and only limited trial data from geographically or clinically diverse patient subgroups. To address some of the clinical and translational gaps in knowledge we thus plan a clinical registry to assess safety and performance of a novel design of a drug eluting
A real-world, all-comers coronary artery disease (CAD) population undergoing percutaneous coronary intervention (PCI) and suitable for treatment with a Paclitaxel Coated Coronary Balloon Dilatation Catheter.
Study Population - 500 Patients
Conditions
- CAD - Coronary Artery Disease
Sponsors & Collaborators
-
Craigavon Area Hospital
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-31
- Primary Completion
- 2026-05-31
- Completion
- 2027-05-31
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