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

RecruitingNAAges 18 Years - anyAllNational Institute of Cardiology, Warsaw, Poland
NCT06275386 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * \<18 years of age * myocardial infarction * cardiogenic shock * severe valvular disease * 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
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What it tests

  • Paclitaxel Drug-coated balloon
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Where

1 site
National Institute of Cardiology
Warsaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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