REgistry of Paclitaxel Coated Drug Eluting Balloon in All Comers PaTients

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

NCT Number	NCT06899555
Lead Sponsor	Craigavon Area Hospital
Conditions	CAD - Coronary Artery Disease
Enrollment	500 participants
Start Date	2025-05
Primary Completion	2026-05 (estimated)
Study Completion	2027-05 (estimated)
Updated on ClinicalTrials.gov	2025-03-28