Translumina Launches SPARX Study on Complex Coronary Artery Disease Treatment

Translumina Therapeutics has officially launched the global randomized controlled trial (RCT) named SPARX. This multinational study will compare a strategy of primarily using drug-coated balloons (DCB) versus modern drug-eluting stents (DES) in patients diagnosed with complex coronary artery disease.

The SPARX trial aims to generate comparable insights and address key clinical questions regarding the safety, efficacy, and long-term outcomes of DCB treatment. The findings are expected to influence future clinical practices and international guideline recommendations.

Professor Adnan Kastrati, lead investigator from Deutsches Herzzentrum, highlighted the clinical rationale. He stated that while drug-eluting stents have advanced, permanent metallic implants can lead to late complications. DCB technology offers an alternative without a permanent implant, but randomized evidence for complex conditions remains limited.

The study will enroll 1,380 patients across 10 countries with a two-year follow-up period. The primary endpoint is a one-year "device-oriented composite endpoint" (DOCE). The results are intended to help define the role of DCB in contemporary coronary interventions.