Translumina Initiates SPARX RCT to Advance Evidence for DCBs in Complex Coronary Disease

October 15, 2026—Translumina Therapeutics Private Limited, India, announced initiation of the SPARX global randomized controlled trial (RCT), which is sponsored by the company.

According to the company, SPARX is evaluating a drug-coated balloon (DCB)-first strategy against contemporary drug-eluting stents (DES) in patients with complex coronary artery disease.

Translumina stated that the SPARX RCT is designed to generate comparative evidence in order to address key clinical questions regarding the safety, efficacy, and long-term outcomes of a “leave nothing behind” treatment strategy, with the potential to shape future clinical practice and international guideline recommendations for DCBs in complex coronary intervention.

Leaders of the trial include:

• Study Chairperson: Professor Adnan Kastrati, MD, from German Heart Centre in Munich, Germany
• Global Lead Principal Investigator: Professor Florim Cuculi, MD, from Luzerner Kantonsspital in Luzern, Switzerland
• Global Coprincipal Investigator: Praveen Chandra, MD, from Medanta-The Medicity in Gurgaon, India

In the Translumina press release, they discussed the rationale and significance of the trial.

“Despite advances in DES technology, permanent metallic implants may be associated with late adverse events beyond the first year,” commented Prof Kastrati. “DCBs, which leave no permanent implant, offer a therapeutic alternative, supported by growing evidence across multiple lesion subsets. However, randomized evidence in complex coronary artery disease remains limited. SPARX has been designed with the aim to further define the role of DCBs in contemporary coronary intervention.”

Prof. Cuculi added, “SPARX has been designed as a multinational randomized trial comparing a DCB-first strategy with contemporary DES across a broad spectrum of complex coronary lesions. The study will enroll 1,380 patients across 10 countries with 2-year follow-up and a 1-year Device-Oriented Composite Endpoint as the primary endpoint. In addition, SPARX will provide randomized head-to-head comparative data between two established paclitaxel-coated balloon technologies. We believe SPARX aims to define the role of DCBs in contemporary coronary intervention.”

Finally, Dr. Chandra stated, “India represents one of the world’s highest-risk coronary artery disease populations, with a high prevalence of diabetes and diffuse complex coronary disease. This makes it an important setting for evaluating DCBs in contemporary clinical practice. We believe SPARX intends to generate clinically relevant evidence that support treatment decisions for physicians in contemporary coronary intervention.”