RecruitingNot Applicable

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

Poland30 participantsStarted 2024-03-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

In-segment late lumen loss

Timeframe: 6-months

Trial details

NCT IDNCT06275386

SponsorNational Institute of Cardiology, Warsaw, Poland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Maksymilian Opolski

0048(22)3434127 mopolski@ikard.pl

View on ClinicalTrials.gov More Coronary Artery Disease trials