DUBSTENT DIABETES Trial of Combined PCI Approach Enrolls First Patient 

September 16, 2025—Teleflex Incorporated announced the enrollment of the first patient in the DUBSTENT DIABETES trial that will evaluate a dual-device strategy for percutaneous coronary intervention (PCI) in patients with diabetes mellitus. The devices used in the trial are from the Vascular Intervention business of Biotronik, which Teleflex acquired in 2025.

According to the company, the randomized, investigator-initiated clinical study will evaluate the safety and efficacy of combining drug-coated balloon (DCB) angioplasty with drug-eluting stent (DES) implantation compared to single-device strategies of DCB or DES only in diabetic patients with de novo coronary artery lesions.

Teleflex stated that the DUBSTENT DIABETES trial will enroll 120 diabetes patients at high-volume centers in Ireland who will be randomized to receive either a combination of the Pantera Lux paclitaxel DCB catheter and the Orsiro Mission sirolimus DES or the Pantera Lux DCB catheter alone or the Orsiro Mission DES alone. As a bailout option, the Freesolve resorbable magnesium scaffold would be considered in the DCB-only arm to assess the leave-nothing-behind approach.

The primary endpoint is percentage diameter stenosis at 6 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 5 years, stated the company. The study is intended to address a critical unmet need, as patients with diabetes continue to experience higher rates of stent failure despite advances in DES technology, noted Teleflex.

Professor Robert A. Byrne, who is Director of Cardiology at Mater Private Network, Dublin, Ireland, is Coordinating Principal Investigator of the study.

“This trial explores a promising approach to improve outcomes in a high-risk population,” commented Prof. Byrnes in the Teleflex press release. “By combining the benefits of DCBs and sirolimus-eluting stents, we are interested to see the impact on restenosis and long-term vessel health in patients with diabetes.”