Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention
Launched by NATIONAL INSTITUTE OF CARDIOLOGY, WARSAW, POLAND · Feb 22, 2024
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
The IMAGINATION trial is a study looking at a new treatment option for patients with a condition called chronic total occlusion (CTO), which means a coronary artery is completely blocked. The trial is testing a special type of balloon, called a drug-coated balloon (DCB), to see if it is effective and safe for these patients. Participants in the study will receive this treatment and will be monitored using imaging tests to check on their heart health before the procedure and again six months later. There will also be a follow-up test at 12 months for some patients.
To join the trial, patients need to be between 65 and 74 years old and have specific symptoms, like chest pain or confirmed heart issues, that require treatment for their blocked artery. They should not have other serious heart conditions or complications that could affect their treatment. Participants will undergo a procedure guided by advanced imaging and will receive close follow-up care to ensure their safety and the effectiveness of the treatment. This trial is currently recruiting participants, and it represents an important step in finding better ways to treat patients with blocked coronary arteries.
Gender
ALL
Eligibility 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
About National Institute Of Cardiology, Warsaw, Poland
The National Institute of Cardiology in Warsaw, Poland, is a leading research institution dedicated to advancing the understanding and treatment of cardiovascular diseases. Renowned for its commitment to innovative clinical research, the Institute focuses on improving patient outcomes through comprehensive studies that encompass prevention, diagnosis, and therapeutic strategies. With a multidisciplinary team of experts and state-of-the-art facilities, the National Institute of Cardiology plays a pivotal role in contributing to global cardiovascular knowledge and enhancing clinical practices in the field.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Warsaw, Mazowieckie, Poland
Patients applied
Trial Officials
Maksymilian Opolski
Principal Investigator
National Institute of Cardiology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported