WAYNE, PA — Teleflex Incorporated (NYSE: TFX) has announced the enrollment of the first patient in the DUBSTENT DIABETES trial, a new clinical study designed to evaluate whether combining two devices can improve outcomes for diabetic patients undergoing heart procedures.
The trial will test a dual-device strategy for percutaneous coronary intervention (PCI), a common procedure to open blocked arteries. Researchers will compare the use of drug-coated balloon (DCB) angioplasty combined with a drug-eluting stent (DES) against the use of either device alone in patients with diabetes who have newly diagnosed coronary artery blockages.
Despite advances in stent technology, diabetic patients remain at higher risk for restenosis—when arteries narrow again after treatment. The study also includes an option to use Teleflex’s Freesolve™ Resorbable Magnesium Scaffold in the DCB-only group, which could provide a “leave-nothing-behind” approach by using a device that eventually dissolves.
“This trial explores a promising approach to improve outcomes in a high-risk population,” said Professor Robert A. Byrne, coordinating principal investigator and director of cardiology at Mater Private Network in Dublin. “By combining the benefits of drug-coated balloons and sirolimus-eluting stents, we are interested to see the impact on restenosis and long-term vessel health in patients with diabetes.”
The study will enroll 120 patients across major centers in Ireland. Participants will be randomly assigned to one of three groups: the combination of Pantera™ Lux™ DCB and Orsiro™ Mission™ DES, the Pantera™ Lux™ DCB alone, or the Orsiro™ Mission™ DES alone. The primary measure of success will be artery narrowing at six months, with additional outcomes tracked for up to five years, including heart attack, need for repeat procedures, clot formation, and overall quality of life.
“We are committed to advancing evidence-based solutions for complex patient populations,” said Prof. Dr. Georg Nollert, vice president of medical affairs for vascular intervention at Teleflex. “We are proud to support this important investigator-led study, which may help shape future treatment strategies for patients with diabetes undergoing PCI.”
If successful, the trial could pave the way for new treatment standards for diabetic patients, who face some of the highest risks of complications following heart interventions.
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