SPARX Global Randomized Controlled Trial by Translumina Initiated to Advance Evidence for Drug-Coated Balloons in Complex Coronary Disease

The SPARX Global Randomized Controlled Trial has been officially initiated to compare a drug-coated balloon (DCB)-first strategy against contemporary drug-eluting stents (DES) in complex coronary artery disease. Launched as a multinational RCT across Lucerne, Switzerland, and New Delhi, India, SPARX is designed to address unresolved questions on safety, efficacy, and long-term outcomes for a “leave nothing behind” approach. The trial plans to enroll 1,380 patients across 10 countries, with two-year follow-up and a one-year Device-Oriented Composite Endpoint (DOCE) as the primary endpoint. It will also provide randomized head-to-head comparisons between two established paclitaxel-coated balloon technologies. SPARX is positioned to generate evidence that could influence future clinical practice and international guidelines.