The randomized, investigator-initiated trial evaluates a dual-device strategy for percutaneous coronary intervention (PCI) in patients with diabetes mellitus.

DUBSTENT DIABETES investigates the safety and efficacy of combining drug-coated balloon (DCB) angioplasty with drug-eluting stent (DES) implantation compared to single-device strategies (DCB or DES only) in diabetic patients with de novo coronary artery lesions. It also includes the Freesolve resorbable magneisum scaffold (RMS) as a bail-out option in the DCB-only arm. This would assess the leave-nothing-behind approach.

Teleflex said the study addresses a critical unmet need as patients with diabetes experience higher rates of stent failure.

In the study, investigators plan to enroll 120 diabetes patients across high-volume centers in Ireland. They intend to randomize patients to receive a range of treatments. Some get a combination of the Pantera Lux DCB catheter and Orsiro Mission DES. Some receive either device on its own.