Heart artery balloon study seeks Long-Term answers
NCT ID NCT06915597
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is looking at how well drug-coated balloons work for treating narrowed heart arteries. Researchers will follow 1,500 adults who get this treatment to see how they do in the short and long term. The goal is to gather more information on the success and safety of this approach in different situations.
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.
- Participants
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About 1,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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May 2026
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.
Who is studied
The study population will consist of adult patients (≥18 years) with coronary artery disease who undergo percutaneous coronary intervention (PCI) in routine clinical practice in participating centers and are treated with a drug-coated balloon (DCB) for at least one target coronary lesion. The registry will include patients across a broad spectrum of clinical presentations, including stable coronary artery disease and acute coronary syndromes, and will encompass a wide range of lesion subsets such as de novo lesions, in-stent restenosis, bifurcation lesions, small and large vessels, and chronic total occlusions. Both prospectively and retrospectively enrolled patients will be included, reflecting real-world practice without additional diagnostic or therapeutic interventions beyond standard of care. The population will therefore represent an unselected, all-comer cohort treated with contemporary DCB-based strategies, allowing comprehensive evaluation of clinical and procedural outcomes.
- 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: Age ≥18 years. Patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) in whom a drug-coated balloon (DCB) is used as the intended treatment strategy for at least one target lesion. DCB use in any clinical presentation, including stable coronary artery disease and acute coronary syndromes. DCB treatment for different lesion subsets, including de novo lesions, in-stent restenosis, bifurcation lesions, small and large vessels, and chronic total occlusions. Successful lesion preparation allowing DCB angioplasty (residual stenosis ≤30% and absence of flow-limiting dissection before DCB inflation, according to operator judgment). Availability of baseline clinical, angiographic, and procedural data. Ability to provide informed consent for prospective enrollment or availability of data according to local regulations for retrospective inclusion. Planned clinical follow-up. Exclusion Criteria: Primary treatment strategy without the use of a drug-coated balloon (e.g., exclusive drug-eluting stent implantation without DCB). Cardiogenic shock at the time of index procedure. Life expectancy less than 1 year due to non-cardiac comorbidities. Contraindication to antiplatelet therapy. Known severe allergy to contrast media not amenable to premedication. Pregnancy. Inability to comply with clinical follow-up. Participation in another interventional clinical trial that could confound outcome assessment.
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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
5 sites. 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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Bahcelievler Memorial Hospital
RECRUITINGIstanbul, Turkey (Türkiye)
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Bezmialem Vakıf Universitesi
RECRUITINGIstanbul, Turkey (Türkiye)
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Goztepe Medicalpark Hastanesi
RECRUITINGIstanbul, Turkey (Türkiye)
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Kutahya City Hospital
RECRUITINGKütahya, Turkey (Türkiye)
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Pamukkale University
RECRUITINGDenizli, Turkey (Türkiye)
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Other studies related to the condition(s) this trial covers.
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