Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07794839

Drug-coated Balloon Treatment

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

Recruiting

Interested in participating?

Request Info

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Center, Training and Research Hospital, Department of Cardiology

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

SERKAN KAHRAMAN

CONTACT

[email protected]

+905053825921

Serkan Kahraman

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Drug coated balloon

Device

patients treated with drug coated balloon dilatation

Drug eluting stent

Device

patients treated with drug eluting stent implantation

Primary outcomes

  1. target lesion failure

    Time frame: 12 month

    composite endpoint of target lesion revascularization, target vessel myocardial infarction and cardiac death

Study contacts

Contact information is provided by the study sponsor or research team.

SERKAN KAHRAMAN, PROF, MD

CONTACT

[email protected]

+905053825921

Sponsors and collaborators

Lead sponsor

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

Other Gov

Registry information

Official study title

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

Acronym: DCB-ONE TR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.