Drug-Coated Balloon Versus Drug-eluting Stent Angioplasty for Treatment of Chronic Total Occlusion - The DCB-CTO Trial

NCT07369765 · tracked via the Priya Life Science Turkey tracker

Sponsor

Biruni University

Phase

Not applicable

Started

2025-08-28

Last updated

2026-01-27

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Drug-Eluting Stent GroupDrug Coated Balloon Group

Drug-Eluting Stent Group: 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 Group: 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 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.

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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * • 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. Exclusion Criteria: * 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; * 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.

Primary outcome measure(s)

Target vessel patency evaluated by QCA — From enrollment to the 6th month angiograhic follow-up
Angiographic patency of the treated CTO vessel
Major adverse cardiovascular events (MACE) — From the enrollment to the end of 6th month follow-up
Composite of cardiac death, myocardial infarction, and target vessel revascularization

Trial sites (1)

Facility	City	Region	Status
Biruni University	Istanbul	Turkey (Türkiye)	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07369765 on ClinicalTrials.gov ↗ ← All trials in Turkey