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

NCT07369765 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-01-27

No results posted yet for this 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.

Conditions

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.

Sponsors & Collaborators

  • Biruni University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-28
Primary Completion
2026-08-01
Completion
2027-08-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07369765 on ClinicalTrials.gov