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Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention
Sponsor: National Institute of Cardiology, Warsaw, Poland
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.
Official title: Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention (IMAGINATION)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-03-24
Completion Date
2026-05
Last Updated
2026-01-02
Healthy Volunteers
No
Interventions
Paclitaxel Drug-coated balloon
Percutaneous coronary intervention of the actual CTO body with a paclitaxel drug-coated balloon.
Locations (1)
National Institute of Cardiology
Warsaw, Masovian Voivodeship, Poland