Coronary Artery DiseaseDCB-CTONCT07369765
Drug-Coated Balloon Versus Drug-eluting Stent Angioplasty for Treatment of Chronic Total Occlusion - The DCB-CTO Trial
A study testing Drug-Eluting Stent Group and Drug Coated Balloon Group in people with Coronary Artery Disease, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Chronic total occlusion (CTO) remains one of the most challenging lesions in coronary artery disease management. Percutaneous coronary intervention using drug-eluting stents is currently a standard treatment approach; however, drug-coated balloon angioplasty has emerged as a potential alternative strategy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Drug-Eluting Stent Group and Drug Coated Balloon Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Aug 2025to 1 Aug 2027
- Phase
- Interventional
- 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
Who may be able to join
- • Definite or probable CTO as per CTO-ARC definition
- CTO length ≥ 20 mm and ≤ 40 mm;
- High likelihood (≥90 %) of CTO-PCI success (balance between CTO lesion complexity and operator expertise);
- Successful treatment of any non-CTO lesions at least 1 month before randomization;
- CTO lesion location in a vessel segment with diameter ≥ 2.5 mm;
- Successful intraplaque (intraluminal) wiring (extraplaque tracking < 10 mm or < 50% of occlusion length) with no flow-limiting dissection and a TIMI flow ≥ 2 after initial predilation with NC balloon.
Who cannot join
- Life expectancy < 1 year as result of non-cardiac conditions;
- Multiple CTO lesions that require recanalization;
- Target lesion is an in-stent CTO;
- Angiographic grade 3 calcifications in the CTO segment (Appendix 2);
- Recent acute coronary syndrome (< 1 month);
- Cardiogenic shock or inability to stay in supine position for long time;
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- Severe kidney failure (eGFR ≤ 30 mL/min);
- Any planned non-CTO PCI < 12 months after randomization;
- Anticipated less compliance of the patients to complete the following or taking medical therapy;
- Patient or legal representative unable or unwilling to provide written informed consent prior to study enrollment;
- Pregnancy or childbearing age unless a recent pregnancy test is negative.
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
Biruni University
Istanbul, 34147
SEVKET GORGULU, sevket5@yahoo.com
About this study
Official title: Drug-Coated Balloon Versus Drug-eluting Stent Angioplasty for Treatment of Chronic Total Occlusion
Chronic total occlusion (CTO) remains one of the most challenging lesions in coronary artery disease management. Percutaneous coronary intervention using drug-eluting stents is currently a standard treatment approach; however, drug-coated balloon angioplasty has emerged as a potential alternative strategy.
This study aims to compare the clinical and angiographic outcomes of drug-coated balloon angioplasty versus drug-eluting stent implantation in patients undergoing percutaneous coronary intervention for chronic total occlusion. The study will include adult patients diagnosed with CTO who meet the predefined eligibility criteria. Outcomes related to procedural success and follow-up results will be evaluated to assess the effectiveness of both treatment strategies.
Read the detailed description
Chronic total occlusion (CTO) represents one of the most complex and technically demanding lesion subsets in the management of coronary artery disease. CTO lesions are characterized by complete coronary artery occlusion with Thrombolysis in Myocardial Infarction (TIMI) grade 0 flow for a duration of at least three months and are frequently associated with increased procedural complexity, longer intervention times, and higher rates of restenosis and repeat revascularization.
Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is currently considered the standard interventional treatment for CTO lesions and has demonstrated favorable outcomes in terms of vessel patency and symptom relief. Nevertheless, DES implantation is associated with potential limitations, including permanent metallic implantation, risk of late stent failure, in-stent restenosis, and the need for prolonged dual antiplatelet therapy. As a result, alternative strategies that avoid permanent implants have gained increasing interest.
Drug-coated balloon (DCB) angioplasty has emerged as a promising alternative approach in selected coronary lesions by delivering antiproliferative drugs to the vessel wall without leaving behind a permanent scaffold. The use of DCBs may offer theoretical advantages in CTO interventions, including preservation of native vessel anatomy, reduced risk of late adverse events, and potential facilitation of future interventions if needed. However, evidence directly comparing DCB angioplasty with DES implantation in the setting of CTO remains limited.
The present study is designed to compare the clinical and angiographic outcomes of DCB angioplasty versus DES implantation in adult patients undergoing PCI for chronic total occlusion. Eligible patients with a confirmed diagnosis of CTO who meet predefined inclusion and exclusion criteria will be enrolled. The choice of revascularization strategy will follow the study protocol, and procedural success will be assessed according to standardized angiographic and clinical definitions.
Clinical outcomes, including procedural success, major adverse cardiovascular events, need for repeat revascularization, and other relevant follow-up parameters, will be evaluated during the follow-up period. Angiographic outcomes, such as vessel patency and restenosis, will also be assessed when applicable. By comparing these two treatment strategies, this study aims to provide further evidence to inform optimal interventional management of CTO lesions and to clarify the potential role of drug-coated balloon angioplasty as an alternative to drug-eluting stent implantation in this challenging patient population.
- Conditions
- Coronary Artery Disease
- Being tested
- Drug-Eluting Stent Group, Drug Coated Balloon Group
- Keywords
- CHRONIC TOTAL OCCLUSION, DRUG COATED BALLOON, CORONARY ARTERY 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.
Drug-Eluting Stent GroupDevice
In the drug-eluting stent group, any commercially available CE-certified second-generation drug-eluting stent will be allowed for the treatment of chronic total occlusion. Stent implantation will be performed according to standard clinical practice and the manufacturer's instructions for use. The use of more than one drug-eluting stent is permitted if deemed necessary by the operator. All devices used in this study are commercially available, and the instructions for use can be found in the trial master file and investigator site file.
Drug Coated Balloon GroupDevice
Percutaneous coronary intervention using a drug-coated balloon for the treatment of chronic total occlusion. The drug-coated balloon is used according to standard clinical practice and the manufacturer's instructions for use.
| Study group | Role | What they receive |
|---|---|---|
| Drug Coated Balloon Group | Active comparator | For this study, only one paclitaxel-coated balloon platform (Protégé™ Drug-Coated Balloon, Translumina, India) will be used in the drug-coated balloon group. The Protégé balloon catheter will be inflated for 1 minute in the chronic total occlusion segment. If multiple inflations are required with the same balloon, additional inflations of 30 seconds with an increase of 2 atm compared to the previous inflation will be allowed, up to a maximum of three inflations, which is a unique feature of the M3i DCB technology. The use of more than one drug-coated balloon is permitted if clinically required. All devices used are commercially available and used according to the manufacturer's instructions for use. Receives: Device: Drug Coated Balloon Group |
| Drug-Eluting Stent Group | Active comparator | In the drug-eluting stent group, any commercially available CE-certified second-generation drug-eluting stent will be allowed for the treatment of chronic total occlusion. Stent implantation will be performed according to standard clinical practice and the manufacturer's instructions for use. The use of more than one drug-eluting stent is permitted if deemed necessary by the operator. All devices used in this study are commercially available, and the instructions for use can be found in the trial master file and investigator site file. Receives: Device: Drug-Eluting Stent Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vessel patency evaluated by QCA
Angiographic patency of the treated CTO vessel
Measured: From enrollment to the 6th month angiograhic follow-up
Major adverse cardiovascular events (MACE)
Composite of cardiac death, myocardial infarction, and target vessel revascularization
Measured: From the enrollment to the end of 6th month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start28 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Biruni 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevket Gorgulu, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369765
- Sponsor's protocol ID
- 2024-BIAEK/12-9
- Acronym
- DCB-CTO
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Coated Balloon Versus Drug-eluting Stent Angioplasty for Treatment of Chronic Total Occlusion
- ClinicalTrials.gov ID
- NCT07369765
- Acronym / sponsor ID
- DCB-CTO / 2024-BIAEK/12-9
- Conditions
- Coronary Artery Disease
- Keywords
- CHRONIC TOTAL OCCLUSION, DRUG COATED BALLOON, CORONARY ARTERY DISEASE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 27 Jan 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.
Chronic total occlusion (CTO) remains one of the most challenging lesions in coronary artery disease management. Percutaneous coronary intervention using drug-eluting stents is currently a standard treatment approach; however, drug-coated balloon angioplasty has emerged as a potential alternative strategy.
This study aims to compare the clinical and angiographic outcomes of drug-coated balloon angioplasty versus drug-eluting stent implantation in patients undergoing percutaneous coronary intervention for chronic total occlusion. The study will include adult patients diagnosed with CTO who meet the predefined eligibility criteria. Outcomes related to procedural success and follow-up results will be evaluated to assess the effectiveness of both treatment strategies.
Detailed description
Chronic total occlusion (CTO) represents one of the most complex and technically demanding lesion subsets in the management of coronary artery disease. CTO lesions are characterized by complete coronary artery occlusion with Thrombolysis in Myocardial Infarction (TIMI) grade 0 flow for a duration of at least three months and are frequently associated with increased procedural complexity, longer intervention times, and higher rates of restenosis and repeat revascularization.
Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is currently considered the standard interventional treatment for CTO lesions and has demonstrated favorable outcomes in terms of vessel patency and symptom relief. Nevertheless, DES implantation is associated with potential limitations, including permanent metallic implantation, risk of late stent failure, in-stent restenosis, and the need for prolonged dual antiplatelet therapy. As a result, alternative strategies that avoid permanent implants have gained increasing interest.
Drug-coated balloon (DCB) angioplasty has emerged as a promising alternative approach in selected coronary lesions by delivering antiproliferative drugs to the vessel wall without leaving behind a permanent scaffold. The use of DCBs may offer theoretical advantages in CTO interventions, including preservation of native vessel anatomy, reduced risk of late adverse events, and potential facilitation of future interventions if needed. However, evidence directly comparing DCB angioplasty with DES implantation in the setting of CTO remains limited.
The present study is designed to compare the clinical and angiographic outcomes of DCB angioplasty versus DES implantation in adult patients undergoing PCI for chronic total occlusion. Eligible patients with a confirmed diagnosis of CTO who meet predefined inclusion and exclusion criteria will be enrolled. The choice of revascularization strategy will follow the study protocol, and procedural success will be assessed according to standardized angiographic and clinical definitions.
Clinical outcomes, including procedural success, major adverse cardiovascular events, need for repeat revascularization, and other relevant follow-up parameters, will be evaluated during the follow-up period. Angiographic outcomes, such as vessel patency and restenosis, will also be assessed when applicable. By comparing these two treatment strategies, this study aims to provide further evidence to inform optimal interventional management of CTO lesions and to clarify the potential role of drug-coated balloon angioplasty as an alternative to drug-eluting stent implantation in this challenging patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Coated Balloon Group | Active comparator | Device: Drug Coated Balloon GroupFor this study, only one paclitaxel-coated balloon platform (Protégé™ Drug-Coated Balloon, Translumina, India) will be used in the drug-coated balloon group. The Protégé balloon catheter will be inflated for 1 minute in the chronic total occlusion segment. If multiple inflations are required with the same balloon, additional inflations of 30 seconds with an increase of 2 atm compared to the previous inflation will be allowed, up to a maximum of three inflations, which is a unique feature of the M3i DCB technology. The use of more than one drug-coated balloon is permitted if clinically required. All devices used are commercially available and used according to the manufacturer's instructions for use. |
| Drug-Eluting Stent Group | Active comparator | Device: Drug-Eluting Stent GroupIn the drug-eluting stent group, any commercially available CE-certified second-generation drug-eluting stent will be allowed for the treatment of chronic total occlusion. Stent implantation will be performed according to standard clinical practice and the manufacturer's instructions for use. The use of more than one drug-eluting stent is permitted if deemed necessary by the operator. All devices used in this study are commercially available, and the instructions for use can be found in the trial master file and investigator site file. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- • Definite or probable CTO as per CTO-ARC definition
Key exclusion criteria (11 listed)
- Life expectancy < 1 year as result of non-cardiac conditions;
- Multiple CTO lesions that require recanalization;
- Target lesion is an in-stent CTO;
- Angiographic grade 3 calcifications in the CTO segment (Appendix 2);
- Recent acute coronary syndrome (< 1 month);
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-Eluting Stent GroupIn the drug-eluting stent group, any commercially available CE-certified second-generation drug-eluting stent will be allowed for the treatment of chronic total occlusion. Stent implantation will be performed according to standard clinical practice and the manufacturer's instructions for use. The use of more than one drug-eluting stent is permitted if deemed necessary by the operator. All devices used in this study are commercially available, and the instructions for use can be found in the trial master file and investigator site file. | Device | Drug-Eluting Stent Group |
| Drug Coated Balloon GroupPercutaneous coronary intervention using a drug-coated balloon for the treatment of chronic total occlusion. The drug-coated balloon is used according to standard clinical practice and the manufacturer's instructions for use. | Device | Drug Coated Balloon Group |
Primary outcome
Target vessel patency evaluated by QCA
Time frame: From enrollment to the 6th month angiograhic follow-up
Angiographic patency of the treated CTO vessel
Major adverse cardiovascular events (MACE)
Time frame: From the enrollment to the end of 6th month follow-up
Composite of cardiac death, myocardial infarction, and target vessel revascularization
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 27 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-Eluting Stent Group and Drug Coated Balloon Group in people with Coronary Artery Disease, run by Biruni University at 1 site 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 11 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 27 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 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 Sevket Gorgulu, MD (+905059383527, sevket5@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vessel patency evaluated by QCA (time frame: From enrollment to the 6th month angiograhic follow-up). The study lists 2 primary outcomes in all. 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 27 Jan 2026.