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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBiruni University

About this trial

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 criteria

Qualifiers

• 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;

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • Drug-Eluting Stent Group
  • Drug Coated Balloon Group

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators