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

ConditionCoronary Artery Disease

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Drug-Eluting Stent Group
Device
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
Device
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.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Drug Coated Balloon GroupActive comparator 1 intervention

Group B: Drug-Eluting Stent GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Target vessel patency evaluated by QCA

Angiographic patency of the treated CTO vessel

Time frame

From enrollment to the 6th month angiograhic follow-up

Major adverse cardiovascular events (MACE)

Composite of cardiac death, myocardial infarction, and target vessel revascularization

Time frame

From the enrollment to the end of 6th month follow-up

Sponsors and contacts

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Biruni University

Lead sponsor

Source ClinicalTrials.gov

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