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

Recruiting now · Not applicable

Conditions studied: Coronary Artery Disease, Total Occlusion of Coronary Artery

In brief

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.

Key facts

Study ID

NCT06275386

Run by

National Institute of Cardiology, Warsaw, Poland

People needed

30

Starts

2024-03-24

Expected to finish

2026-05-01

Last updated by the study team

2026-01-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• <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

Where it is running

• National Institute of Cardiology — Warsaw, Masovian Voivodeship, Poland (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.