Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Institute of Cardiology, Warsaw, Poland
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
<18 years of age
myocardial infarction
cardiogenic shock
severe valvular disease
Trial design
Treatments tested in this trial
- Paclitaxel Drug-coated balloon
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov