Drug-coated balloon therapy for coronary artery disease
Official title: The Role of Drug Coated Balloons in the Treatment of Coronary Artery Disease: an Observational Nationwide Experience
Run by Istanbul Mehmet Akif Ersoy Educational and Training Hospital · NCT07794839 · Data updated 2026-11-12
This study tests how well drug-coated balloon angioplasty works for people with coronary artery disease who are treated with a drug-coated balloon or a drug-eluting stent.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Istanbul Mehmet Akif Ersoy Educational and Training Hospital Government |
| Locations | 1 site (Istanbul) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | January 1, 2027 |
| Study ends | April 1, 2027 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT07794839 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with silent ischemia, chronic coronary syndrome, or ACS who have undergone drug-eluting balloon angioplasty.
✕Probably not a fit
Patients with ST-elevation myocardial infarction requiring urgent, emergent care or those unable to attend follow-up may derive limited or no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project looks at outcomes from using drug-coated balloons (DCB) and drug-eluting stents in patients with coronary artery disease. It considers cases ranging from silent ischemia to acute coronary syndromes and compares procedural approaches in complex lesions. The study contextualizes how DCB therapy performs in de novo lesions and bifurcations, with attention to safety, patency, and clinical outcomes over follow-up. By observing real-world practice, it aims to clarify whether DCB provides comparable or favorable results to stents in selected patients. The investigation is conducted at a major Istanbul hospital network with no randomization.
Why it matters
Potential benefit: If successful, the approach could clarify when DCB is a suitable alternative to stents and help tailor treatments to patient and lesion characteristics.
How similar studies have gone: Previous studies have shown promising results for DCB in bifurcation and complex lesions, but evidence varies and more observational data are being gathered.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: 1- Patients aged 18 years and older; 2- Patients with silent ischemia, chronic coronary syndrome, or ACS; 3- Patients treated with drug-eluting balloon angioplasty. Exclusion criteria: 1- Patients with ST-segment elevation myocardial infarction and/or cardiogenic shock; 2- Patients with graft vessels from CABG surgery; 3- Patients who are contraindicated from dual antiplatelet therapy; 4- Patients with a life expectancy of less than 1 year; 5- Pregnant patients; 6- Patients with active bleeding, hematological disease, or cancer; 7- Patients unable to attend clinical follow-ups; 8- Patients with planned surgery within the next 12 months.
Where it's running
-
University of Health Sciences, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Center, Training and Research Hospital, Department of Cardiology
Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Serkan Kahraman, Prof, Md
- Email: serkankahraman_86@outlook.com
- Phone: +905053825921
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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.