Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06275386

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

Led by National Institute of Cardiology, Warsaw, Poland · Updated on 2026-01-02

30

Participants Needed

1

Research Sites

109 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • <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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Institute of Cardiology

Warsaw, Masovian Voivodeship, Poland, 04-628

Actively Recruiting

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Research Team

M

Maksymilian Opolski

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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