Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention (IMAGINATION)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Total Occlusion of Coronary Artery
• Intervention / Treatment: Device: Paclitaxel Drug-coated balloon

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maksymilian Opolski; Phone Number: 0048(22)3434127; Email: mopolski@ikard.pl

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 04-628
      • National Institute of Cardiology
      • Contact: Agnieszka Zdziennicka; Email: azdziennicka@ikard.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug-coated balloon; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
HQ-IVUS outcomes assessed directly post-PCI	minimal lumen diameter (mm); minimal lumen area (mm2); maximum plaque burden (%)	immediately post-procedure (1 day)
Physiologic outcomes assessed directly post-PCI	the ratio of pd/pa; cRR (absolute values); FFR (absolute values)	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)	6-months
HQ-IVUS outcomes at 6-months follow-up	minimal lumen diameter (mm); minimal lumen area (mm2); maximum plaque burden (%)	6-months
Physiologic outcomes at 6-months follow-up	the ratio of pd/pa; cRR (absolute values); FFR (absolute values)	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 (%)	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)	12-months

Collaborators and Investigators

• Sponsor: National Institute of Cardiology, Warsaw, Poland
• Investigators: Principal Investigator: Maksymilian Opolski, National Institute of Cardiology

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; chronic total occlusion; drug-coated balloon
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: 2.31/II/24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No