NCT07369765Recruiting
Drug-Coated Balloon Versus Drug-eluting Stent Angioplasty for Treatment of Chronic Total Occlusion - The DCB-CTO Trial
Drug-Coated Balloon Versus Drug-eluting Stent Angioplasty for Treatment of Chronic Total Occlusion
Source: ClinicalTrials.gov · Last updated 27 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 3 Jan 2026
- Start date
- 28 Aug 2025
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- Biruni University
- Diseases
- Coronary artery disease
- NCT number
- NCT07369765
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 28 Aug 2025 to the primary completion date, 1 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Life expectancy \< 1 year as result of non-cardiac conditions;
- Recent acute coronary syndrome (\< 1 month);
Lab values
- Severe kidney failure (eGFR ≤ 30 mL/min);
Age
- Pregnancy or childbearing age unless a recent pregnancy test is negative.
Other
- Multiple CTO lesions that require recanalization;
- Target lesion is an in-stent CTO;
- Angiographic grade 3 calcifications in the CTO segment (Appendix 2);
- Cardiogenic shock or inability to stay in supine position for long time;
- Any planned non-CTO PCI \< 12 months after randomization;
Who the study is looking for
- • 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Biruni University Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.