NCT06275386 Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention
| NCT ID | NCT06275386 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Cardiology, Warsaw, Poland |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-03-24 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-03-24 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Maksymilian Opolski
PRINCIPAL INVESTIGATOR
National Institute of Cardiology
Frequently Asked Questions
Who can join the NCT06275386 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06275386 currently recruiting?
Yes, NCT06275386 is actively recruiting participants. Contact the research team at mopolski@ikard.pl for enrollment information.
Where is the NCT06275386 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT06275386 clinical trial?
NCT06275386 is sponsored by National Institute of Cardiology, Warsaw, Poland. The principal investigator is Maksymilian Opolski at National Institute of Cardiology. The trial plans to enroll 30 participants.