Teleflex (NYSE:TFX) announced today that it enrolled the first patient in its DUBSTENT DIABETES trial.
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.
DUBSTENT DIABETES has a primary endpoint of percentage diameter stenosis at six months, assessed by quantitative coronary angiography. Secondary endpoints include death, myocardial infarction, target lesion revascularization, target lesion thrombosis, target vessel revascularization and quality of life up to five years.
“We are committed to advancing evidence-based solutions for complex patient populations. We are proud to support this important investigator-led study, which may help shape future treatment strategies for patients with diabetes undergoing PCI,” said Dr. Georg Nollert, VP, Medical Affairs for Vascular Intervention at Teleflex.”
