Coronary Artery DiseaseDCB-ONE TRNCT07794839
Drug-coated Balloon Treatment
An observational study of Coronary Artery Disease, run by Istanbul Mehmet Akif Ersoy Educational and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Evaluation of the efficacy and clinical outcomes of drug-eluting balloon therapy in ticyaici coronary artery disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- drug coated balloon and drug eluting stent
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: coronary artery lesions treated with drug coated balloon dilatation or drug eluting stent implantation
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Center, Training and Research Hospital, Department of Cardiology
Istanbul
SERKAN KAHRAMAN, +905053825921, serkankahraman_86@outlook.com
Serkan Kahraman
About this study
Official title: The Role of Drug Coated Balloons in the Treatment of Coronary Artery Disease: an Observational Nationwide Experience
Evaluation of the efficacy and clinical outcomes of drug-eluting balloon therapy in ticyaici coronary artery disease.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- drug coated balloon, drug eluting stent
- Keywords
- drug coated balloon, drug eluting stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug coated balloonDevice
patients treated with drug coated balloon dilatation
drug eluting stentDevice
patients treated with drug eluting stent implantation
| Study group | Role | What they receive |
|---|---|---|
| drug coated balloon | lesions treated with drug coated balloon Receives: Device: drug coated balloon | |
| drug eluting stent | lesions treated with drug eluting stent Receives: Device: drug eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
target lesion failure
composite endpoint of target lesion revascularization, target vessel myocardial infarction and cardiac death
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Serkan Kahraman, Istanbul Mehmet Akif Ersoy Educational and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794839
- Sponsor's protocol ID
- DCB TURK
- Acronym
- DCB-ONE TR
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shin D, Singh M, Shlofmitz E, Scheller B, Latib A, Kandzari DE, Zaman A, Mylotte D, Dakroub A, Malik S, Sakai K, Jeremias A, Moses JW, Shlofmitz RA, Stone GW, Ali ZA. Paclitaxel-coated versus sirolimus-coated balloon angioplasty for coronary artery disease: A systematic review and meta-analysis. Catheter Cardiovasc Interv. 2024 Sep;104(3):425-436. doi: 10.1002/ccd.31154. Epub 2024 Jul 24.
PubMed 39044661Fezzi S, Serruys PW, Cortese B, Scheller B, Alfonso F, Jeger R, Colombo A, Joner M, Shin ES, Kleber F, Latib A, Rissanen TT, Eccleshall S, Ribichini F, Tao L, Koo BK, Chieffo A, Ge J, Granada JF, Stoll HP, Spaulding C, Cavalcante R, Abizaid A, Muramatsu T, Boudoulas KD, Waksman R, Mehran R, Cutlip D, Krucoff M, Stone GW, Garg S, Onuma Y. Indications for Use of Drug-Coated Balloons in Coronary Intervention: Academic Research Consortium Position Statement. J Am Coll Cardiol. 2025 Oct 14;86(15):1170-1202. doi: 10.1016/j.jacc.2025.07.049.
PubMed 41062231Camaj A, Leone PP, Colombo A, Vinayak M, Stone GW, Mehran R, Dangas G, Kini A, Sharma SK. Drug-Coated Balloons for the Treatment of Coronary Artery Disease: A Review. JAMA Cardiol. 2025 Feb 1;10(2):189-198. doi: 10.1001/jamacardio.2024.4244.
PubMed 39714903
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Drug Coated Balloons in the Treatment of Coronary Artery Disease: an Observational Nationwide Experience
- ClinicalTrials.gov ID
- NCT07794839
- Acronym / sponsor ID
- DCB-ONE TR / DCB TURK
- Conditions
- Coronary Artery Disease
- Keywords
- drug coated balloon, drug eluting stent
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training HospitalOther government
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drug coated balloon | – | Device: drug coated balloonlesions treated with drug coated balloon |
| drug eluting stent | – | Device: drug eluting stentlesions treated with drug eluting stent |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- coronary artery lesions treated with drug coated balloon dilatation or drug eluting stent implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drug coated balloonpatients treated with drug coated balloon dilatation | Device | drug coated balloon |
| drug eluting stentpatients treated with drug eluting stent implantation | Device | drug eluting stent |
Primary outcome
target lesion failure
Time frame: 12 month
composite endpoint of target lesion revascularization, target vessel myocardial infarction and cardiac death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Results publication: PubMed 39044661Shin D, Singh M, Shlofmitz E, Scheller B, Latib A, Kandzari DE, Zaman A, Mylotte D, Dakroub A, Malik S, Sakai K, Jeremias A, Moses JW, Shlofmitz RA, Stone GW, Ali ZA. Paclitaxel-coated versus sirolimus-coated balloon angioplasty for coronary artery disease: A systematic review and meta-analysis. Catheter Cardiovasc Interv. 2024 Sep;104(3):425-436. doi: 10.1002/ccd.31154. Epub 2024 Jul 24.
- Results publication: PubMed 41062231Fezzi S, Serruys PW, Cortese B, Scheller B, Alfonso F, Jeger R, Colombo A, Joner M, Shin ES, Kleber F, Latib A, Rissanen TT, Eccleshall S, Ribichini F, Tao L, Koo BK, Chieffo A, Ge J, Granada JF, Stoll HP, Spaulding C, Cavalcante R, Abizaid A, Muramatsu T, Boudoulas KD, Waksman R, Mehran R, Cutlip D, Krucoff M, Stone GW, Garg S, Onuma Y. Indications for Use of Drug-Coated Balloons in Coronary Intervention: Academic Research Consortium Position Statement. J Am Coll Cardiol. 2025 Oct 14;86(15):1170-1202. doi: 10.1016/j.jacc.2025.07.049.
- Results publication: PubMed 39714903Camaj A, Leone PP, Colombo A, Vinayak M, Stone GW, Mehran R, Dangas G, Kini A, Sharma SK. Drug-Coated Balloons for the Treatment of Coronary Artery Disease: A Review. JAMA Cardiol. 2025 Feb 1;10(2):189-198. doi: 10.1001/jamacardio.2024.4244.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Istanbul Mehmet Akif Ersoy Educational and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SERKAN KAHRAMAN, PROF, MD (+905053825921, serkankahraman_86@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
target lesion failure (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07794839, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.