Clinical Trial

Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention

Study acronym: IMAGINATION
Recruiting
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Summary
The IMAGINATION trial is an investigator-initiated, prospective, single-center study of symptomatic patients with a native chronic total occlusion (CTO) undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB). Post-PCI IVUS and fractional flow reserve (FFR) at baseline and at 6-months follow-up will be performed. In addition, patients included in the coronary computed tomography angiography (CCTA) substudy will undergo CCTA at 12-months follow-up. The aim of this study is to evaluate the efficacy and safety of DCB-only approach in native coronary CTO.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-02-22; most recent amendment 2025-12-29.
Status change: Not Yet Recruiting → Recruiting 2024-10-03
Trial Details
NCT Number NCT06275386
Lead Sponsor National Institute of Cardiology, Warsaw, Poland
Conditions Coronary Artery Disease, Total Occlusion of Coronary Artery
Enrollment 30 participants
Start Date 2024-03-24
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2026-01-02