Drug-coated balloons for different types of coronary artery disease
Official title: Procedural Success and Short- and Long-Term Outcomes of Drug-Coated Coronary Balloons Used in Different Clinical Scenarios
Run by Kutahya Health Sciences University · NCT06915597 · Data updated 2026-11-12
This registry will try drug-coated balloons as an alternative or addition to stents in people with coronary artery disease to see if they work well and last over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | Kutahya Health Sciences University Academic / other |
| Locations | 5 sites (Denizli and 4 other locations) |
| Status | Recruiting |
| Started | May 31, 2025 |
| Main results expected | May 31, 2026 |
| Study ends | May 31, 2026 |
| Registry record updated | January 13, 2026 |
| Trial ID | NCT06915597 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with coronary artery disease undergoing PCI in whom the operator intends to use a DCB for at least one target lesion, including stable disease and acute coronary syndromes, are eligible.
✕Probably not a fit
Patients whose lesions cannot be adequately prepared (residual stenosis >30% or flow‑limiting dissection) or who require primary stenting are unlikely to benefit from a DCB‑based approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, observational registry in Türkiye enrolling consecutive patients undergoing PCI where a drug-coated balloon (DCB) strategy is used, either alone or with bailout stenting, across a broad range of lesion types. Both prospective and retrospective cases from high-volume centers will have standardized collection of demographic, clinical, angiographic, procedural, pharmacological, and follow-up data. Operators will record lesion preparation techniques, intravascular imaging use, DCB device details, and immediate procedural outcomes. The registry is intended to reflect real-world contemporary DCB practice and to document short-term procedural success and longer-term clinical outcomes.
Why it matters
Potential benefit: If successful, this could broaden use of DCBs as a stent‑sparing option for selected coronary lesions and reduce stent-related complications and repeat procedures.
How similar studies have gone: Prior studies have shown benefit of DCBs for in‑stent restenosis and small‑vessel disease, but evidence is more limited for de novo large vessels, bifurcations, and chronic total occlusions.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Pamukkale University
Denizli, Turkey (Türkiye) Recruiting -
Bahcelievler Memorial Hospital
Istanbul, Turkey (Türkiye) Recruiting -
Bezmialem Vakıf Universitesi
Istanbul, Turkey (Türkiye) Recruiting -
Goztepe Medicalpark Hastanesi
Istanbul, Turkey (Türkiye) Recruiting -
Kutahya City Hospital
Kütahya, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Fatih Kahraman, Associate Professor
- Email: fatih.kahraman@ksbu.edu.tr
- Phone: +905442764616
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.