September 11, 2025- Teleflex Incorporated announced the enrollment of the first patient in the DUBSTENT DIABETES trial. The randomized, investigator-initiated clinical study will evaluate a dual-device strategy for percutaneous coronary intervention (PCI) in patients with diabetes mellitus.
The DUBSTENT DIABETES trial will investigate 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. As a bail-out option, the FreesolveTM Resorbable Magnesium Scaffold (RMS) would be considered in the DCB only arm to assess the leave-nothing behind approach. The study addresses a critical unmet need, as patients with diabetes continue to experience higher rates of stent failure despite advances in DES technology.