Teleflex has enrolled the first subject in the investigator-initiated DUBSTENT DIABETES trial aimed at diabetic patients undergoing percutaneous coronary intervention (PCI).
This randomised trial will assess a dual-device strategy involving drug-coated balloon (DCB) angioplasty and drug-eluting stent (DES) implantation against single-device approaches using either DCB or DES alone.
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The study will focus on diabetic patients with de novo coronary artery lesions while addressing a gap in treatment, as these patients often face higher rates of stent failure despite advancements in DES technology.
It will also consider the Freesolve resorbable magnesium scaffold (RMS) as a bail-out option for patients receiving DCB alone, in line with a leave-nothing-behind approach.
Teleflex vascular intervention medical affairs vice-president Dr Georg Nollert said: 鈥淲e are committed to advancing evidence-based solutions for complex patient populations.
鈥淲e are proud to support this important investigator-led study, which may help shape future treatment strategies for patients with diabetes undergoing PCI.鈥�
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By GlobalDataThe trial aims to enrol 120 subjects across Ireland鈥檚 high-volume centres.
Participants will be randomly assigned to one of three groups, including a combination of the Pantera Lux DCB catheter and the Orsiro Mission DES, the Pantera Lux DCB catheter alone, or the Orsiro Mission DES alone.
The primary endpoint of the study is the percentage diameter stenosis at six months, measured via quantitative coronary angiography.
Secondary endpoints will include myocardial infarction, mortality, target lesion revascularisation, target vessel revascularisation, target lesion thrombosis and quality of life assessments over five years.
In February, Teleflex announced the separation into two independently traded entities, with completion expected by mid-2026.
Teleflex NewCo will encompass the urology, acute care, and OEM sectors while Teleflex RemainCo will include the vascular access, interventional, and surgical divisions.
