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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a long-blocked heart artery who have symptoms or signs of poor blood supply and need a procedure to open it. The artery is treated with a drug-coated balloon.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- A native chronic total occlusion (a long-standing complete blockage of a heart artery, found by invasive coronary angiography). The local heart team must see a clinical need to open it, with angina or similar symptoms and/or documented ischemia or viability.
Main reasons for not taking part
- Myocardial infarction
- Cardiogenic shock
- Severe valvular disease
- Estimated life expectancy under 1 year
- Contraindication to PCI
Read by machine on 12 November 2026.
Where in Poland
- National Institute of CardiologyWarsaw, PolandContact: Agnieszka ZdziennickaTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.