Drug-coated balloon versus drug‑eluting stent to reopen chronically blocked coronary arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional trial compares outcomes after percutaneous coronary intervention using drug‑coated balloon (DCB) angioplasty versus drug‑eluting stent (DES) implantation in adults with chronic total occlusion (CTO). Participants must meet predefined anatomical and procedural criteria, including CTO length 20–40 mm, vessel diameter ≥2.5 mm, and successful intraplaque wiring with TIMI flow ≥2 after predilation. Patients will be assigned to DCB or DES and followed for procedural success, angiographic patency, clinical events, and need for repeat revascularization. The trial is conducted at Biruni University in Istanbul and targets patients with a high likelihood of PCI success.

Why it matters

Who can join: the full rules

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.

Where it's running

• Biruni University
  Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Sevket Gorgulu, MD
• Email: sevket5@yahoo.com
• Phone: +905059383527

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.