Using a drug-coated balloon for treating blocked coronary arteries
Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention (IMAGINATION)
This study is testing whether a drug-coated balloon can safely help people with blocked coronary arteries feel better during a heart procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institute of Cardiology, Warsaw, Poland Academic / other |
| Locations | 1 site (Warsaw, Masovian Voivodeship) |
| Trial ID | NCT06275386 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are symptomatic patients with a native chronic total occlusion who meet specific clinical criteria for PCI.
Not a fit: Patients with conditions such as myocardial infarction, severe valvular disease, or those who are not suitable for PCI will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a safer and more effective treatment option for patients with chronic total occlusion of coronary arteries.
How similar studies have performed: While there have been advancements in CTO PCI techniques, the specific use of drug-coated balloons for this purpose is still being explored and has not been widely tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Warsaw, Masovian Voivodeship
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.