Translumina launches SPARX global trial for drug coated coronary balloons
Medical device company Translumina initiated the multinational SPARX randomized controlled trial to evaluate drug coated balloon treatment strategies against conventional drug eluting stents in coronary disease
Translumina Therapeutics Private Limited has initiated the SPARX Global Randomized Controlled Trial (RCT) to evaluate the efficacy of a drug-coated balloon (DCB)-first strategy against contemporary drug-eluting stents (DES) in patients with complex coronary artery disease. The trial aims to generate comparative evidence to address key clinical questions regarding the safety, efficacy, and long-term outcomes of this treatment strategy.
With a focus on complex coronary artery disease, the SPARX trial will enroll 1,380 patients across 10 countries and compare the SPARX DCB-first approach with established paclitaxel-coated balloon technologies. The study's primary endpoint is a one-year Device-Oriented Composite Endpoint (DOCE), and the results are expected to shape future clinical practice and international guideline recommendations.
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