Using a drug-coated balloon for treating blocked coronary arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The IMAGINATION trial is a prospective, single-center investigation focusing on symptomatic patients with chronic total occlusion (CTO) of coronary arteries. It aims to evaluate the efficacy and safety of a drug-coated balloon (DCB) during percutaneous coronary intervention (PCI) guided by intravascular ultrasound (IVUS). Patients will undergo baseline assessments and follow-up evaluations at 6 and 12 months to assess the outcomes of the DCB treatment. The study seeks to provide insights that could lead to future randomized trials comparing DCB to traditional drug-eluting stents.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* \<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's running

• National Institute of Cardiology
  Warsaw, Masovian Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Maksymilian Opolski — National Institute of Cardiology
• Study coordinator: Maksymilian Opolski
• Email: mopolski@ikard.pl
• Phone: 0048(22)3434127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.