Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention
Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention (IMAGINATION)
National Institute of Cardiology, Warsaw, Poland
30 participants
Mar 24, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria9
- <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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Interventions
Percutaneous coronary intervention of the actual CTO body with a paclitaxel drug-coated balloon.
Locations(1)
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NCT06275386