First Patient Enrolled in DUBSTENT DIABETES Trial: Targeting Improved PCI Outcomes for Diabetic Patients
Teleflex (NYSE:TFX) has initiated the DUBSTENT DIABETES trial with the enrollment of its first patient. This randomized, investigator-initiated clinical study aims to evaluate a dual-device strategy for percutaneous coronary intervention (PCI) in diabetic patients.
The trial will compare three approaches: a combination of Pantera Lux DCB Catheter with Orsiro Mission DES, Pantera Lux DCB alone, and Orsiro Mission DES alone. The study will enroll 120 diabetes patients across Irish centers, with primary endpoints measuring diameter stenosis at six months and secondary endpoints tracking various cardiac events over five years.
Teleflex (NYSE:TFX) ha avviato lo studio DUBSTENT DIABETES con l'arruolamento del primo paziente. Questo studio clinico randomizzato, promosso dagli investigatori, valuta una strategia a doppio dispositivo per l'intervento coronarico percutaneo (PCI) nei pazienti diabetici.
La sperimentazione confronterà tre approcci: la combinazione di catetere DCB Pantera Lux con stent medicato Orsiro Mission DES, il solo Pantera Lux DCB e il solo Orsiro Mission DES. Verranno arruolati 120 pazienti diabetici in centri irlandesi; l'endpoint primario è la stenosi di diametro a sei mesi, mentre gli endpoint secondari monitoreranno diversi eventi cardiaci nell'arco di cinque anni.
Teleflex (NYSE:TFX) ha iniciado el ensayo DUBSTENT DIABETES con la inclusión de su primer paciente. Este estudio clínico aleatorizado, impulsado por los investigadores, pretende evaluar una estrategia de doble dispositivo para la intervención coronaria percutánea (PCI) en pacientes diabéticos.
El ensayo comparará tres enfoques: la combinación de catéter DCB Pantera Lux con stent liberador de fármaco Orsiro Mission DES, únicamente Pantera Lux DCB y únicamente Orsiro Mission DES. Se reclutarán 120 pacientes con diabetes en centros de Irlanda; el objetivo principal es la estenosis del diámetro a los seis meses y los objetivos secundarios registrarán distintos eventos cardíacos durante cinco años.
Teleflex (NYSE:TFX)가 첫 환자 등록과 함께 DUBSTENT DIABETES 시험을 시작했습니다. 이 무작위 배정된 연구는 연구자 주도 임상 시험으로, 당뇨병 환자에서 경피적 관상동맥 중재술(PCI)에 대한 이중 장치 전략을 평가하는 것을 목표로 합니다.
시험은 세 가지 접근법을 비교합니다: Pantera Lux DCB 카테터와 Orsiro Mission DES의 병용, Pantera Lux DCB 단독, Orsiro Mission DES 단독. 아일랜드의 여러 기관에서 당뇨병 환자 120명을 등록할 예정이며, 1차 평가지표는 6개월 시점의 직경 협착률이고 2차 평가지표는 5년간 다양한 심장 사건을 추적합니다.
Teleflex (NYSE:TFX) a lancé l'essai DUBSTENT DIABETES avec le recrutement de son premier patient. Cette étude clinique randomisée, initiée par les investigateurs, vise à évaluer une stratégie à double dispositif pour l'intervention coronarienne percutanée (ICP) chez les patients diabétiques.
L'essai comparera trois approches : la combinaison du cathéter DCB Pantera Lux avec le stent actif Orsiro Mission DES, le Pantera Lux DCB seul, et l'Orsiro Mission DES seul. L'étude recrutera 120 patients diabétiques dans des centres irlandais ; le critère principal est la sténose de diamètre à six mois et les critères secondaires suivront divers événements cardiaques sur cinq ans.
Teleflex (NYSE:TFX) hat die DUBSTENT DIABETES-Studie mit der Einschreibung des ersten Patienten gestartet. Diese randomisierte, von den Prüfern initiierte klinische Studie zielt darauf ab, eine Dual-Device-Strategie für die perkutane koronare Intervention (PCI) bei Diabetespatienten zu bewerten.
Die Studie vergleicht drei Ansätze: die Kombination aus Pantera Lux DCB-Katheter und Orsiro Mission DES, alleiniger Einsatz des Pantera Lux DCB und alleiniger Einsatz des Orsiro Mission DES. Es werden 120 Diabetespatienten an Zentren in Irland eingeschlossen; primärer Endpunkt ist die Durchmesserstenose nach sechs Monaten, sekundäre Endpunkte erfassen verschiedene kardiale Ereignisse über fünf Jahre.
- None.
- Small trial size of only 120 patients limits statistical power
- Study limited to Irish centers may affect global applicability of results
Insights
Teleflex begins DUBSTENT DIABETES trial evaluating combination therapy for diabetic PCI patients, potentially addressing higher stent failure rates in this population.
Teleflex has initiated the DUBSTENT DIABETES trial, enrolling its first patient in a study that could potentially address a significant challenge in interventional cardiology. The trial focuses on diabetic patients, who experience higher rates of stent failure despite advancements in drug-eluting stent technology.
The 120-patient randomized study will compare three approaches for percutaneous coronary intervention (PCI): a dual-device strategy combining the Pantera™ Lux™ Drug-Coated Balloon (DCB) with the Orsiro™ Mission™ Drug-Eluting Stent (DES), versus either device used alone. The trial includes the FreesolveTM Resorbable Magnesium Scaffold as a bail-out option in the DCB-only arm, supporting a "leave-nothing-behind" approach.
The study's design is particularly noteworthy for targeting diabetic patients with de novo coronary artery lesions - a challenging population with historically worse outcomes. The primary endpoint measures percentage diameter stenosis at six months, with secondary endpoints tracking crucial clinical outcomes including death, myocardial infarction, and target lesion revascularization up to five years.
While this early-stage enrollment doesn't guarantee commercial success, it demonstrates Teleflex's strategic commitment to evidence-based medicine and expanding applications for its vascular intervention portfolio. The investigator-initiated trial format also suggests credibility among practicing clinicians, with leadership from respected cardiologist Professor Robert A. Byrne. Success could position Teleflex competitively in the high-value diabetes patient segment, where improved outcomes could drive adoption of a dual-device approach.
The Trial Evaluates a Combined PCI Approach Using Drug-Coated Balloons and Drug-Eluting Stents
WAYNE, Pa., Sept. 11, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, today 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 (PCI) in patients with diabetes mellitus.
The DUBSTENT DIABETES trial will investigate 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. As a bail-out option, the FreesolveTM Resorbable Magnesium Scaffold (RMS) 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 technology1.
“This trial explores a promising approach to improve outcomes in a high-risk population,” said Professor Robert A. Byrne, Coordinating Principal Investigator of the study and Director of Cardiology at Mater Private Network, Dublin, Ireland. “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 DUBSTENT DIABETES trial will enroll 120 diabetes patients across high-volume centers in Ireland. Participants will be randomized to receive either:
- A combination of the Pantera™ Lux™ DCB Catheter (which is part of the Lux™ family of Paclitaxel-coated balloons) and the Orsiro™ Mission™ DES
- The Pantera™ Lux™ DCB Catheter alone
- The Orsiro™ Mission™ DES alone
The primary endpoint is 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,” said Prof. Dr. Georg Nollert, Vice President 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.”
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in the world of healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
Not all products may be available in all countries. The Pantera™ Lux™ Drug-Coated Balloon Catheter is not approved in United States and the Freesolve™ Resorbable Magnesium Scaffold (RMS) is limited to investigational use in the United States. Indications for use may vary by geographic location.
*Professor Byrne is a paid consultant of Teleflex Incorporated or its affiliates.
**Study sponsored by Teleflex Incorporated or its affiliates.
Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.
CAUTION: Federal (USA) law restricts these devices for sale or use by or on the order of a physician.
Freesolve™ RMS CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.
Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, Freesolve, LMA, Lux, Mission, Orsiro, Orsiro Mission, Pantera, Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S. and/or other countries. Refer to the Instructions for Use for a complete listing of the indications, contraindications, warnings, and precautions. Information in this press release is not a substitute for the product Instructions for Use. Not all products may be available in all countries. Please contact your local representative.
© 2025 Teleflex Incorporated. All rights reserved. MC-011244 Rev 0.
References:
1. https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.123.013302
Contacts:
Teleflex Lawrence Keusch
Vice President, Investor Relations and Strategy Development
investor.relations@teleflex.com
610-948-2836
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