Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention
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 photon-counting 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.
- EligibilityCriteria: 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 without severe calcification within the occlusion site as defined by invasive coronary angiography (according to Mintz et al. classification) 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 severe calcification within the occlusion site as defined by invasive coronary angiography CTO recanalization using antegrade or retrograde dissection and re-entry techniques - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult