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RECRUITING
NCT06275386
NA

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

Sponsor: National Institute of Cardiology, Warsaw, Poland

View on ClinicalTrials.gov

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

DEVICE

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