Teleflex (TFX) 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 in patients with diabetes mellitus. The DUBSTENT DIABETES trial will investigate the safety and efficacy of combining drug-coated balloon angioplasty with drug-eluting stent 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 Freesolve Resorbable Magnesium Scaffold 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.
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