An interventional study of Paclitaxel Drug-coated balloon in Coronary Artery Disease and Total Occlusion of Coronary Artery, sponsored by National Institute of Cardiology, Warsaw, Poland. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by National Institute of Cardiology, Warsaw, Poland · Not applicable, Interventional, and Treatment
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.
Whereas CTO PCI techniques and success rates have significantly improved during the last decade, CTOs still pose a significant technical challenge for accurate stent sizing (primarily due to negative remodelling and subsequent distal vessel dilatation post-PCI) resulting in a potentially increased risk of stent failure. Hence, the concept of DCB as a definitive treatment for native CTO is appealing and warrants further investigation. The IMAGINATION trial has been designed as a prospective research to: 1) investigate both the immediate and intermediate-term angiographic, IVUS and physiologic efficacy outcomes as well as safety profile of DCB for native vessel coronary CTO, and 2) to provide a basis for future randomized clinical trial comparing DCB to drug-eluting stents.
All patients with CTO will be screened for potential inclusion in the study. After obtaining written informed consent, patients with successful intraplaque guidewire crossing through CTO lesion (excluding the use of dissection and re-entry techniques) will undergo IVUS-guided PCI with a scoring balloon (balloon-to-artery ratio of 1:1) followed by the use of a paclitaxel-coated balloon. Following satisfactory angiographic result, IVUS and physiological measurements (FFR and non-hyperemic pressure ratios) in the target vessel will be performed. At 6-months follow-up, invasive angiography with IVUS and FFR/non-hyperemic pressure ratios in the target vessel will be repeated. In addition, patients with pre-procedural CCTA will undergo follow-up CCTA after 12 months (CCTA substudy).
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 30 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →National Institute of Cardiology, Warsaw, Poland is the lead sponsor of 53 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will undergo PCI of the native coronary CTO with a DCB.
Device: Paclitaxel Drug-coated balloon
Percutaneous coronary intervention of the actual CTO body with a paclitaxel drug-coated balloon.
In-segment late lumen loss
The difference by subtracting the minimal lumen diameter (MLD) at follow-up from the MLD postprocedure. In-segment equals DCB plus the proximal and distal 5-mm margins.
Time frame: 6-months
Angiographic outcomes assessed directly post-PCI
* minimum lumen diameter (mm) * residual diameter stenosis (%) * the rate of bail-out stenting after DCB use (%)
Time frame: immediately post-procedure (1 day)
HD-IVUS outcomes assessed directly post-PCI
* minimal lumen diameter (mm) * minimal lumen area (mm2) * maximum plaque burden (%)
Time frame: immediately post-procedure (1 day)
Physiologic outcomes assessed directly post-PCI
* the ratio of pd/pa * cRR (absolute values) * FFR (absolute values)
Time frame: immediately post-procedure (1 day)
Angiographic outcomes at 6-months follow-up
* minimum lumen diameter (mm) * residual diameter stenosis (%) * in-segment binary restenosis (≥50% diameter stenosis) * the rate of target vessel re-occlusion (yes/no)
Time frame: 6-months
HD-IVUS outcomes at 6-months follow-up
* minimal lumen diameter (mm) * minimal lumen area (mm2) * maximum plaque burden (%)
Time frame: 6-months
Physiologic outcomes at 6-months follow-up
* the ratio of pd/pa * cRR (absolute values) * FFR (absolute values)
Time frame: 6-months
Computed tomographic outcomes at 12-months follow-up (CCTA substudy)
* minimal lumen area (mm2) * maximum plaque burden (%) * area stenosis (%) * diameter stenosis (%) * remodeling index (absolute values) * total plaque volume (mm3) * calcified plaque volume (mm3) * non-calcified plaque volume (mm3) * low-attenuation plaque volume (mm3) * percentage of change in in-segment total plaque volume (%) * percentage of change in in-segment calcified plaque volume (%) * percentage of change in in-segment non-calcified plaque volume (%) * percentage of change in in-segment low-attenuation plaque volume (%) * percentage of change in in-segment remodeling index (%)
Time frame: 12-months
Clinical outcomes at 12-months follow-up
• the rate of target lesion failure (composite endpoint of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization)
Time frame: 12-months
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National Institute of Cardiology, Warsaw, Poland