Drug-coated balloons for different types of coronary artery disease
Procedural Success and Short- and Long-Term Outcomes of Drug-Coated Coronary Balloons Used in Different Clinical Scenarios
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 |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kutahya Health Sciences University Academic / other |
| Locations | 5 sites (Denizli and 4 other locations) |
| Trial ID | NCT06915597 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Denizli and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.