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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06275386
Other study ID # 2.31/II/24
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date September 1, 2025

Study information

Verified date February 2024
Source National Institute of Cardiology, Warsaw, Poland
Contact Maksymilian Opolski
Phone 0048(22)3434127
Email mopolski@ikard.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Description:

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 photon-counting CCTA at 12 months follow-up (CCTA substudy).


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Paclitaxel Drug-coated balloon
Percutaneous coronary intervention of the actual CTO body with a paclitaxel drug-coated balloon.

Locations

Country Name City State
Poland National Institute of Cardiology Warsaw Mazowieckie

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

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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