Coronary Arterial Disease (CAD)DCB-DCSNCT06915597
Drug-Coated Coronary Balloons in Different Clinical Scenarios
An observational study of Coronary Arterial Disease (CAD), run by Kutahya Health Sciences University at 5 sites in Turkey (Türkiye).
Trial summary
Coronary stents are the best treatment method ever accepted in the treatment of coronary artery stenoses. Due to some limitations and complications of stent use, the operators tried to find new solutions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD)
- How many people
- 1,500 participants
- Where
- 5 sitesTurkey (Türkiye)
- Study dates
- 31 May 2025to 31 May 2026
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients (≥18 years) with coronary artery disease who undergo percutaneous coronary intervention (PCI) in routine clinical practice in participating centers and are treated with a drug-coated balloon (DCB) for at least one target coronary lesion. The registry will include patients across a broad spectrum of clinical presentations, including stable coronary artery disease and acute coronary syndromes, and will encompass a wide range of lesion subsets such as de novo lesions, in-stent restenosis, bifurcation lesions, small and large vessels, and chronic total occlusions. Both prospectively and retrospectively enrolled patients will be included, reflecting real-world practice without additional diagnostic or therapeutic interventions beyond standard of care. The population will therefore represent an unselected, all-comer cohort treated with contemporary DCB-based strategies, allowing comprehensive evaluation of clinical and procedural outcomes.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Turkey (Türkiye)5 sites, 5 recruiting
- Recruiting
Pamukkale University
Denizli
Ismail D Kilic, Professor, +905326434948, idogukilic@pau.edu.tr
Mehmet Kilinc, MD, 5073505984, klncmehmet@hotmail.com
- Recruiting
Bahcelievler Memorial Hospital
Istanbul
Omer Goktekin, Professor, 5323252371, ogoktekin@gmail.com
Hasim Tuner, MD, 5456176667, hasimtuner@gmail.com
- Recruiting
Bezmialem Vakıf Universitesi
Istanbul
Mahmut Uluganyan, Professor, 5055853534, uluganyan@gmail.com
- Recruiting
Goztepe Medicalpark Hastanesi
Istanbul
Adnan Kaya, Professor, 5324009765, adnankaya@ymail.com
- Recruiting
Kutahya City Hospital
Kütahya
Fatih Kahraman, Associate Professor, 5442764616, drfkahraman@hotmail.com
About this study
Official title: Procedural Success and Short- and Long-Term Outcomes of Drug-Coated Coronary Balloons Used in Different Clinical Scenarios
Coronary stents are the best treatment method ever accepted in the treatment of coronary artery stenoses. Due to some limitations and complications of stent use, the operators tried to find new solutions. Drug Coated Balloons (DCBs) have been accepted as a new method in the treatment of in-stent restenosis and small vessel disease. Furthermore, they have been used in the treatment of de novo coronary lesions, chronic total occlusions and bifucation lesions. But data is limited in the short and long term success of DCBs in all these clinical scenarios. In our study we aimed to investigate the procedural success and short and long term outcomes of DCB use in different clinical scenarios.
Read the detailed description
The DCB-DCS (Drug-Coated Balloon in Different Clinical Scenarios) Registry is a multicenter, observational study designed to evaluate the safety, feasibility, and clinical outcomes of drug-coated balloon (DCB) angioplasty in a broad spectrum of coronary artery disease presentations and lesion subsets in real-world practice across Türkiye. The registry aims to provide comprehensive evidence on contemporary DCB use beyond conventional in-stent restenosis, including de novo small and large vessels, bifurcation lesions, chronic total occlusions, acute coronary syndromes, and complex lesion morphologies.
Consecutive patients undergoing percutaneous coronary intervention (PCI) with a DCB-based strategy, either as a stand-alone therapy or in combination with bailout stenting, will be prospectively and retrospectively enrolled from participating high-volume centers. Detailed demographic, clinical, laboratory, angiographic, procedural, and pharmacological data will be systematically collected. Lesion characteristics will be classified according to standard angiographic and anatomical criteria, and procedural techniques including lesion preparation strategy (plain balloon, cutting/scoring balloon, high-pressure non-compliant balloon, atherectomy), use of intravascular imaging (IVUS, OCT, OFDI), and DCB type, size, and inflation protocol will be recorded.
The registry will assess short-term procedural success and long-term clinical outcomes, including major adverse cardiovascular events (MACE), target lesion failure, target vessel revascularization, myocardial infarction, stent thrombosis (when applicable), and all-cause and cardiovascular mortality. Subgroup analyses will explore the impact of different clinical presentations, lesion subsets, and procedural strategies on outcomes, with particular emphasis on the role of optimal lesion preparation, intravascular imaging guidance, and the need for bailout stenting.
By reflecting routine clinical practice in a large, unselected population, the DCB-DCS Registry seeks to define optimal procedural standards, identify predictors of success and failure, and generate hypothesis-forming data to guide future randomized controlled trials comparing DCB-based strategies with new-generation drug-eluting stents across diverse coronary scenarios.
- Conditions
- Coronary Arterial Disease (CAD)
- Keywords
- drug coted balloons, coronary artery disease, chronic total occlusions, de novo lesions, small vessel disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Coronary artery disease | Patients with coronary artery disease who were treated with drug coated balloons will be included in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death, target lesion revascularization, target vessel revascularization, myocardial infarction
Cardiac or noncardiac death events will be recorded during follow up. Forthermore, target vessel or lesion revascularization, myocardial infarction will be recorded according to the previously described criteria.
Measured: 12 months
Secondary outcomes (1)
Angina, target vessel revascularization, Procedural success and need for bailout stenting, Major bleeding (BARC ≥3)
Assessment of symptomatic angina status, need for repeat revascularization of the target vessel, procedural success including the requirement for bailout stent implantation, and the occurrence of major bleeding events defined as Bleeding Academic Research Consortium (BARC) type ≥3.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start31 May 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University, Memorial Bahçelievler Hospital, Bezmialem Vakif University, Dicle University, Ordu University, Adana City Training and Research Hospital, Marmara University, Trakya University, Kafkas University Health Research and Application Hospital, Selcuk University, Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Fatih Kahraman, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915597
- Sponsor's protocol ID
- DCB-DCS
- Acronym
- DCB-DCS
- Status last verified
- Jan 2026
- First submitted
- 19 Mar 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Aggregate data will be reported in publications and presentations. Access to patient-level data will be restricted to the study investigators in accordance with local regulations and data protection laws.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedural Success and Short- and Long-Term Outcomes of Drug-Coated Coronary Balloons Used in Different Clinical Scenarios
- ClinicalTrials.gov ID
- NCT06915597
- Acronym / sponsor ID
- DCB-DCS / DCB-DCS
- Conditions
- Coronary Arterial Disease (CAD)
- Keywords
- drug coted balloons, coronary artery disease, chronic total occlusions, de novo lesions, small vessel disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Collaborators
- Pamukkale University, Memorial Bahçelievler Hospital, Bezmialem Vakif University, Dicle University, Ordu University, Adana City Training and Research Hospital, Marmara University, Trakya University, Kafkas University Health Research and Application Hospital, Selcuk University, Istanbul University - Cerrahpasa
- Study start
- 31 May 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 8 Apr 2025 (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.
Coronary stents are the best treatment method ever accepted in the treatment of coronary artery stenoses. Due to some limitations and complications of stent use, the operators tried to find new solutions. Drug Coated Balloons (DCBs) have been accepted as a new method in the treatment of in-stent restenosis and small vessel disease. Furthermore, they have been used in the treatment of de novo coronary lesions, chronic total occlusions and bifucation lesions. But data is limited in the short and long term success of DCBs in all these clinical scenarios. In our study we aimed to investigate the procedural success and short and long term outcomes of DCB use in different clinical scenarios.
Detailed description
The DCB-DCS (Drug-Coated Balloon in Different Clinical Scenarios) Registry is a multicenter, observational study designed to evaluate the safety, feasibility, and clinical outcomes of drug-coated balloon (DCB) angioplasty in a broad spectrum of coronary artery disease presentations and lesion subsets in real-world practice across Türkiye. The registry aims to provide comprehensive evidence on contemporary DCB use beyond conventional in-stent restenosis, including de novo small and large vessels, bifurcation lesions, chronic total occlusions, acute coronary syndromes, and complex lesion morphologies.
Consecutive patients undergoing percutaneous coronary intervention (PCI) with a DCB-based strategy, either as a stand-alone therapy or in combination with bailout stenting, will be prospectively and retrospectively enrolled from participating high-volume centers. Detailed demographic, clinical, laboratory, angiographic, procedural, and pharmacological data will be systematically collected. Lesion characteristics will be classified according to standard angiographic and anatomical criteria, and procedural techniques including lesion preparation strategy (plain balloon, cutting/scoring balloon, high-pressure non-compliant balloon, atherectomy), use of intravascular imaging (IVUS, OCT, OFDI), and DCB type, size, and inflation protocol will be recorded.
The registry will assess short-term procedural success and long-term clinical outcomes, including major adverse cardiovascular events (MACE), target lesion failure, target vessel revascularization, myocardial infarction, stent thrombosis (when applicable), and all-cause and cardiovascular mortality. Subgroup analyses will explore the impact of different clinical presentations, lesion subsets, and procedural strategies on outcomes, with particular emphasis on the role of optimal lesion preparation, intravascular imaging guidance, and the need for bailout stenting.
By reflecting routine clinical practice in a large, unselected population, the DCB-DCS Registry seeks to define optimal procedural standards, identify predictors of success and failure, and generate hypothesis-forming data to guide future randomized controlled trials comparing DCB-based strategies with new-generation drug-eluting stents across diverse coronary scenarios.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary artery disease | – | –Patients with coronary artery disease who were treated with drug coated balloons will be included in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients (≥18 years) with coronary artery disease who undergo percutaneous coronary intervention (PCI) in routine clinical practice in participating centers and are treated with a drug-coated balloon (DCB) for at least one target coronary lesion. The registry will include patients across a broad spectrum of clinical presentations, including stable coronary artery disease and acute coronary syndromes, and will encompass a wide range of lesion subsets such as de novo lesions, in-stent restenosis, bifurcation lesions, small and large vessels, and chronic total occlusions. Both prospectively and retrospectively enrolled patients will be included, reflecting real-world practice without additional diagnostic or therapeutic interventions beyond standard of care. The population will therefore represent an unselected, all-comer cohort treated with contemporary DCB-based strategies, allowing comprehensive evaluation of clinical and procedural outcomes.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death, target lesion revascularization, target vessel revascularization, myocardial infarction
Time frame: 12 months
Cardiac or noncardiac death events will be recorded during follow up. Forthermore, target vessel or lesion revascularization, myocardial infarction will be recorded according to the previously described criteria.
1 secondary outcome
Angina, target vessel revascularization, Procedural success and need for bailout stenting, Major bleeding (BARC ≥3)
Time frame: 12 months
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 13 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Aggregate data will be reported in publications and presentations. Access to patient-level data will be restricted to the study investigators in accordance with local regulations and data protection laws.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arterial Disease (CAD), run by Kutahya Health Sciences University at 5 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Fatih Kahraman, Associate Professor (+905442764616, fatih.kahraman@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death, target lesion revascularization, target vessel revascularization, myocardial infarction (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2026.