RecruitingNot ApplicableNCT06275386

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

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


Sponsor

National Institute of Cardiology, Warsaw, Poland

Enrollment

30 participants

Start Date

Mar 24, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Paclitaxel Drug-coated balloon for people with coronary artery disease and total occlusion of coronary artery. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPaclitaxel 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

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NCT06275386


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