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

Drug-Coated Balloon Versus Drug-eluting Stent Angioplasty for Treatment of Chronic Total Occlusion

This trial will try drug‑coated balloons versus drug‑eluting stents in adults having PCI for chronic total occlusion to see which gives better vessel opening and fewer repeat procedures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sex: All
• Sponsor: Biruni University (Academic / other)
• Locations: 1 site (Istanbul)
• Trial ID: NCT07369765 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with a single CTO suitable for PCI — specifically lesions 20–40 mm long in vessels ≥2.5 mm with successful intraplaque wiring and a high projected chance of procedural success — are ideal candidates.

Not a fit: Patients with multiple CTOs, in‑stent CTOs, severe lesion calcification, recent acute coronary syndrome, severe kidney failure, or life expectancy under one year are unlikely to benefit from inclusion.

Why it matters

Potential benefit: If successful, DCB treatment could open the blocked artery without leaving a permanent metal stent, potentially lowering late complications and making future procedures easier.

How similar studies have performed: Smaller studies and registries of DCBs in selected coronary lesions have shown promising results, but strong randomized evidence specifically for CTOs is still limited.

Eligibility criteria

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 this trial is running

Istanbul

• Biruni University — Istanbul, Turkey (Türkiye) (Recruiting)

Study contacts

• Study coordinator: Sevket Gorgulu, MD

Conditions Coronary Artery Disease; CHRONIC TOTAL OCCLUSION; DRUG COATED BALLOON; CORONARY ARTERY DISEASE