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

Study acronym: IMAGINATION
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Nov 2025 to Dec 31, 2025v5
  2. Primary completion date: Sep 1, 2025 to Nov 2025
    • Study completion date: Oct 1, 2025 to May 2026
    v4
  3. Eligibility criteria shortened, about 25 words
    • Secondary endpoints revised (8)
    • Study description shortened, about 1 word
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study completion date: Sep 1, 2025 to Oct 1, 2025
    • Start date changed from estimate of Mar 1, 2024 to Mar 24, 2024
    • Site details revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06275386
Lead Sponsor National Institute of Cardiology, Warsaw, Poland
Conditions
(from sponsor)		 Coronary Artery Disease, Total Occlusion of Coronary Artery
Related terms Coronary Artery Disease
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov