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

NCT07369765 | Recruiting

• 1 other identifier: 2024-BIAEK/12-9
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Artery Disease

Keywords

CHRONIC TOTAL OCCLUSION; DRUG COATED BALLOON; CORONARY ARTERY DISEASE

Outcome Measures

Primary Outcomes (2)

• Target vessel patency evaluated by QCA

  Angiographic patency of the treated CTO vessel

  From enrollment to the 6th month angiograhic follow-up

• Major adverse cardiovascular events (MACE)

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

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

Study Arms (2)

Drug Coated Balloon Group

ACTIVE COMPARATOR

For this study, only one paclitaxel-coated balloon platform (Protégé™ Drug-Coated Balloon, Translumina, India) will be used in the drug-coated balloon group. The Protégé balloon catheter will be inflated for 1 minute in the chronic total occlusion segment. If multiple inflations are required with the same balloon, additional inflations of 30 seconds with an increase of 2 atm compared to the previous inflation will be allowed, up to a maximum of three inflations, which is a unique feature of the M3i DCB technology. The use of more than one drug-coated balloon is permitted if clinically required. All devices used are commercially available and used according to the manufacturer's instructions for use.

Device: Drug Coated Balloon Group

Drug-Eluting Stent Group

ACTIVE COMPARATOR

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-Eluting Stent Group

Interventions

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-Eluting Stent Group

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.

Drug Coated Balloon Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University

Istanbul, 34147, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Sevket Gorgulu, MD

CONTACT

+905059383527; sevket5@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 27, 2026
• Study Start: August 28, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

TU (1)