Paclitaxel-coated balloon for blocked coronary arteries during stent-free widening
Tests a paclitaxel-coated balloon in adults with fully blocked heart arteries.
Plain-language title generated from the registry record
Registry title: Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention
Key facts
- Where
- Warsaw, PolandSee the site
Where in Poland
- National Institute of CardiologyWarsaw, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Institute of Cardiology, Warsaw, Poland
- Trial code
- NCT06275386
- Record updated
- 2 January 2026
- Original description
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.Read full original descriptionShow less
Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention (IMAGINATION)
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.
Inclusion: clinical indication for CTO PCI as determined by the local heart team (presence of angina or equivalent symptoms and/or documented ischemia or viability); native CTO lesion as defined by invasive coronary angiography; informed consent for participation in the study.
Exclusion: myocardial infarction; severe valvular disease; <18 years of age; cardiogenic shock; estimated life expectancy <1 year; contraindication to PCI; positive pregnancy test or breast-feeding; in-stent CTO; CTO recanalization using antegrade or retrograde dissection and re-entry techniques.