NCT06275386Recruiting
Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention
Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention (IMAGINATION)
Source: ClinicalTrials.gov · Last updated 2 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 7 Feb 2024
- Start date
- 24 Mar 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Diseases
- Coronary artery disease
- NCT number
- NCT06275386
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 24 Mar 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- myocardial infarction
- severe valvular disease
Age
- \<18 years of age
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institute of Cardiology Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.