Could two devices beat one for diabetic heart patients?
NCT ID NCT07303439
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at 120 people with diabetes who have blocked heart arteries. It compares using a drug-coated balloon together with a drug-eluting stent versus using either device alone. The goal is to see which approach keeps arteries open best after 6 months.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mater Private Hospital
RECRUITINGDublin, County Dublin, D07 KWR1, Ireland
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