Translumina Launches Global Trial for Drug-Coated Balloons

The study will track 1,380 patients across 10 countries, utilizing a one-year Device-Oriented Composite Endpoint to measure safety and efficacy. Investigators intend to gather head-to-head data on paclitaxel-coated balloon technologies, addressing a gap in current clinical guidelines regarding the management of high-risk coronary lesions. The trial is particularly focused on populations with high rates of diabetes and diffuse disease, where metallic stents may pose lasting risks.

Prof. Adnan Kastrati, the study chairperson, noted that while stent technology has progressed, permanent implants remain linked to late adverse events. By testing the Protégé Paclitaxel-Coated Balloon, the research team hopes to validate a therapy that preserves vessel integrity. The project, registered under CTRI/2026/04/109375 and NCT07397845, is sponsored by Translumina Therapeutics and will include a two-year follow-up period to assess durability.