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

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 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

Conditions3

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