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Drug-coated Balloon Treatment

The Role of Drug Coated Balloons in the Treatment of Coronary Artery Disease: an Observational Nationwide Experience

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07794839
Acronym
DCB-ONE TR
Enrollment
1000
Registered
2026-08-31
Start date
2026-01-01
Completion date
2027-04-01
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

drug coated balloon, drug eluting stent

Brief summary

Evaluation of the efficacy and clinical outcomes of drug-eluting balloon therapy in ticyaici coronary artery disease.

Detailed description

Coronary artery lesions are a clinical condition of increasing importance, especially in recent years. Due to their complex anatomy and the need for high operator experience, the optimal treatment strategy remains a subject of debate. While drug-eluting stent therapy is a proven treatment method for these patients, drug-eluting balloon angioplasty, which has become increasingly common in recent years, is also an important alternative. Percutaneous interventional treatment approaches for complex coronary artery disease continue to be a subject of research due to their lower success rates, as well as their association with higher complications and adverse cardiovascular outcomes. Particularly in recent years, the encouraging results of drug-eluting balloon angioplasty (DCB) therapy applied in the treatment of de novo coronary artery disease have led to the publication of results regarding the use of DCB in bifurcation lesions (1-3). In bifurcation patients who underwent provisional stenting, a reduction in adverse clinical outcomes was observed in 1-year follow-ups with side branch drug-eluting balloon angioplasty (1). Following the positive outcomes of DCB treatment in patients with true bifurcation lesions, patients who underwent provisional stenting and side branch DCB placement were compared in many studies with patients treated with drug-eluting stents (provisional or double stent strategy). The common result of these studies is that while acute side branch lumen patency was significantly lower in patients treated with DCB compared to the side branch stent group, there was no difference in clinical outcomes between the two groups in long-term clinical follow-up. Furthermore, there are studies showing that long-term lumen loss and TLR were lower in the DCB-treated group compared to the 2-stent group (1-3). In addition, a study in non-LMCA bifurcations found that in patients requiring side branch intervention after provisional stenting, side branch intervention with DCB had better long-term clinical outcomes, particularly regarding spontaneous myocardial infarction, compared to non-compliant coronary balloons (1). In our study, we will examine the development of clinical events in coronary artery disease patients treated with drug-eluting balloon angioplasty.

Interventions

patients treated with drug coated balloon dilatation

DEVICEdrug eluting stent

patients treated with drug eluting stent implantation

Sponsors

Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
target lesion failure12 monthcomposite endpoint of target lesion revascularization, target vessel myocardial infarction and cardiac death

Countries

Turkey (Türkiye)

Contacts

CONTACTSERKAN KAHRAMAN, PROF, MD
serkankahraman_86@outlook.com+905053825921

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026