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RECRUITING
NCT07369765
NA

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

Sponsor: Biruni University

View on ClinicalTrials.gov

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.

Official title: Drug-Coated Balloon Versus Drug-eluting Stent Angioplasty for Treatment of Chronic Total Occlusion

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-08-28

Completion Date

2027-08-01

Last Updated

2026-01-27

Healthy Volunteers

No

Interventions

DEVICE

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.

DEVICE

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.

Locations (1)

Biruni University

Istanbul, Turkey (Türkiye)