Actively Recruiting
Drug-Coated Balloon Versus Drug-eluting Stent Angioplasty for Treatment of Chronic Total Occlusion - The DCB-CTO Trial
Led by Biruni University · Updated on 2026-01-27
200
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Drug-Coated Balloon Versus Drug-eluting Stent Angioplasty for Treatment of Chronic Total Occlusion - The DCB-CTO Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Definite or probable chronic total occlusion (CTO) according to CTO-ARC definition
- CTO length between 20 mm and 40 mm
- High likelihood (≥90%) of success for CTO percutaneous coronary intervention (PCI) based on lesion complexity and operator expertise
- Successful treatment of any non-CTO lesions at least 1 month before randomization
- CTO lesion located in a vessel segment with diameter ≥ 2.5 mm
- Successful intraplaque (intraluminal) wiring with no flow-limiting dissection and TIMI flow ≥ 2 after initial predilation with non-compliant balloon
You will not qualify if you...
- Life expectancy less than 1 year due to non-cardiac conditions
- Multiple CTO lesions requiring recanalization
- Target lesion is an in-stent CTO
- Angiographic grade 3 calcifications in the CTO segment
- Recent acute coronary syndrome within 1 month
- Cardiogenic shock or inability to stay in supine position for extended time
- Severe kidney failure with eGFR ≤ 30 mL/min
- Planned non-CTO PCI within 12 months after randomization
- Anticipated poor compliance with follow-up or medical therapy
- Patient or legal representative unable or unwilling to provide informed consent
- Pregnancy or childbearing age without a recent negative pregnancy test
AI-Screening
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Trial Site Locations
Total: 1 location
1
Biruni University
Istanbul, Turkey (Türkiye), 34147
Actively Recruiting
Research Team
S
Sevket Gorgulu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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