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

About this trial

Last updated 4 months ago

Study ID

2024-BIAEK/12-9

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

All Ages

All Sexes

Trial Timing

Started 9 months ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* • 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.

Exclusion Criteria

* 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.