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NCT Number: NCT06275386

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Total Occlusion of Coronary Artery Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Cardiology

Warsaw, Masovian Voivodeship, 04-628, Poland

Location status: Recruiting

Location contact

Agnieszka Zdziennicka

CONTACT

[email protected]

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paclitaxel Drug-coated balloon

Device

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

Primary outcomes

  1. In-segment late lumen loss

    Time frame: 6-months

    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.

Secondary outcomes

  1. Angiographic outcomes assessed directly post-PCI

    Time frame: immediately post-procedure (1 day)

    • minimum lumen diameter (mm)
    • residual diameter stenosis (%)
    • the rate of bail-out stenting after DCB use (%)

  2. HD-IVUS outcomes assessed directly post-PCI

    Time frame: immediately post-procedure (1 day)

    • minimal lumen diameter (mm)
    • minimal lumen area (mm2)
    • maximum plaque burden (%)

  3. Physiologic outcomes assessed directly post-PCI

    Time frame: immediately post-procedure (1 day)

    • the ratio of pd/pa
    • cRR (absolute values)
    • FFR (absolute values)

  4. Angiographic outcomes at 6-months follow-up

    Time frame: 6-months

    • minimum lumen diameter (mm)
    • residual diameter stenosis (%)
    • in-segment binary restenosis (≥50% diameter stenosis)
    • the rate of target vessel re-occlusion (yes/no)

  5. HD-IVUS outcomes at 6-months follow-up

    Time frame: 6-months

    • minimal lumen diameter (mm)
    • minimal lumen area (mm2)
    • maximum plaque burden (%)

  6. Physiologic outcomes at 6-months follow-up

    Time frame: 6-months

    • the ratio of pd/pa
    • cRR (absolute values)
    • FFR (absolute values)

  7. Computed tomographic outcomes at 12-months follow-up (CCTA substudy)

    Time frame: 12-months

    • 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 (%)

  8. Clinical outcomes at 12-months follow-up

    Time frame: 12-months

    • the rate of target lesion failure (composite endpoint of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization)

Study contacts

Contact information is provided by the study sponsor or research team.

Maksymilian Opolski

CONTACT

[email protected]

0048(22)3434127

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Warsaw, Poland

Other

Registry information

Official study title

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

Acronym: IMAGINATION

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 23, 2024
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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