Coronary Artery Disease Clinical Trial
— IMAGINATIONOfficial title:
Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention (IMAGINATION)
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 photon-counting 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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | September 1, 2025 |
Est. primary completion date | September 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 without severe calcification within the occlusion site as defined by invasive coronary angiography (according to Mintz et al. classification) - 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 - severe calcification within the occlusion site as defined by invasive coronary angiography - CTO recanalization using antegrade or retrograde dissection and re-entry techniques |
Country | Name | City | State |
---|---|---|---|
Poland | National Institute of Cardiology | Warsaw | Mazowieckie |
Lead Sponsor | Collaborator |
---|---|
National Institute of Cardiology, Warsaw, Poland |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In-segment late lumen loss | The difference by subtracting the minimal lumen diametter (MLD) at follow-up from the MLD postprocedure. In-segment equals DCB plus the proximal and distal 5-mm margins. | 6-months | |
Secondary | Angiographic outcomes assessed directly post-PCI | minimum lumen diameter (mm)
residual diameter stenosis (%) the rate of bail-out stenting after DCB use (%) |
immediately post-procedure (1 day) | |
Secondary | HQ-IVUS outcomes assessed directly post-PCI | minimal lumen diameter (mm)
minimal lumen area (mm2) maximum plaque burden (%) |
immediately post-procedure (1 day) | |
Secondary | Physiologic outcomes assessed directly post-PCI | the ratio of pd/pa
cRR (absolute values) FFR (absolute values) |
immediately post-procedure (1 day) | |
Secondary | 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) |
6-months | |
Secondary | HQ-IVUS outcomes at 6-months follow-up | minimal lumen diameter (mm)
minimal lumen area (mm2) maximum plaque burden (%) |
6-months | |
Secondary | Physiologic outcomes at 6-months follow-up | the ratio of pd/pa
cRR (absolute values) FFR (absolute values) |
6-months | |
Secondary | 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 (%) |
12-months | |
Secondary | 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) | 12-months |
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