Home › Trials › NCT07303439
Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Combining a drug-coated balloon and a drug-eluting stent for people with diabetes and new coronary artery blockages

Official title: Randomised Trial of Dual Device Treatment Involving Drug-coated Balloon Angioplasty and Drug-eluting Stent Implantation Compared to Single Device Treatments in Patients With Diabetes Mellitus

Run by Royal College of Surgeons, Ireland · NCT07303439 · Data updated 2026-11-12

This trial tests whether using a drug-coated balloon together with a drug-eluting stent works better than using either device alone for adults with diabetes who have new (de novo) coronary artery lesions.

More Diabetes Mellitus trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment120 (estimated)
SponsorRoyal College of Surgeons, Ireland
Academic / other
Locations1 site (Dublin, County Dublin)
StatusRecruiting
StartedAugust 6, 2025
Main results expectedDecember 16, 2026
Study endsAugust 5, 2031
Registry record updatedDecember 24, 2025
Trial IDNCT07303439 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with diabetes undergoing PCI for de novo obstructive lesions in native coronary arteries who can give informed consent and meet angiographic criteria are ideal candidates.

Probably not a fit

Patients with left main disease, STEMI at presentation, acute cardiogenic shock, severe renal impairment, prior stented (non‑de novo) lesions, or lesions unsuitable for balloon pre-dilation are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

DUBSTENT-DIABETES is a prospective, randomized, multicenter, assessor-blind trial enrolling 120 adults with diabetes undergoing PCI for de novo native coronary lesions. Participants are randomized 1:1:1 to receive Pantera® Lux paclitaxel drug-coated balloon combined with Orsiro® drug-eluting stent, Pantera® Lux DCB alone, or Orsiro DES alone. The trial compares safety and efficacy outcomes, including target lesion failure and restenosis, with standardized angiographic entry criteria and clinical follow-up. Procedures are done at participating centers with follow-up visits to monitor clinical outcomes and device-related events.

Why it matters

Potential benefit: If successful, the combined approach could lower restenosis and target lesion failure, reducing repeat procedures and improving longer-term outcomes for people with diabetes.

How similar studies have gone: Drug-coated balloons and drug-eluting stents have established evidence individually, but using them together in people with diabetes is a novel approach that has not been tested in randomized trials.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patients with acute or chronic coronary syndrome
2. Diagnosis of diabetes
3. Patients undergoing PCI for de novo lesions in native coronary arteries
4. Patients able and willing to provide written informed consent
5. Age ≥ 18 years.
6. Patients able and willing to comply with the study procedures and follow-up.
7. All angiographic inclusion criteria fulfilled:

   1. the lesion has been deemed treatable
   2. the guidewire has crossed the lesion
   3. the lesion has been successfully pre-dilated, where balloon expansion is complete, residual stenosis is less than 50% and thrombolysis in myocardial infarction (TIMI) flow is \>2, and there is no evidence of flow-limiting dissection is seen.

Exclusion Criteria:

1. Lesions located at the left main coronary artery.
2. Patient presents with a ST-elevation myocardial infarction (STEMI).
3. Patient with acute cardiac decompensation or acute cardiogenic shock.
4. Patient with impaired renal function (glomerular filtration rate \< 30 mL/min/1.73 m2).
5. Severe in-stent calcification that prevents a sufficient expansion of the DCB, unless adequately pre-treated, e.g. with super (high) pressure balloon, rotablation or lithotripsy.
6. Evidence of high-grade dissection (National Heart, Lung, and Blood Institute (NHLBI) class C or greater) at baseline
7. Known hypersensitivity or contraindication to sirolimus, paclitaxel, heparin, aspirin, thienopyridines, or iodinated contrast that cannot be pre-treated.
8. Patients unable to take dual antiplatelet therapy for 6-12 months
9. Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.
10. Subject currently enrolled in other investigational device or drug trial in which the primary endpoint has not yet been reached.
11. Anticipated difficulties to complete the angiographic surveillance.
12. Patient with a life expectancy of less than 12 months.
13. Patients lacking mental capacity (i.e. patients suffering from dementia and others) to provide informed consent.
14. The study will not recruit participants who, in the opinion of the investigator, do not have an adequate understanding of English. Only participants who can fully comprehend the implications of participating in the study will be recruited

Where it's running

  • Mater Private Hospital
    Dublin, County Dublin, Ireland     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Diabetes Mellitus 218Coronary Arterial Disease (CAD) 47De Novo Stenosis 3Royal College of Surgeons, Ireland 22
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.