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The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial

Study acronym: VICTORY
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated June 18, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Study completion date: May 30, 2027 to May 30, 2028
    • Eligibility criteria expanded, about 8 words
    • Collaborators expanded, about 5 words
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Feb 28, 2023 to Dec 31, 2024
    • Start date changed from estimate of May 1, 2022 to Nov 22, 2022
    • Study completion date: May 30, 2025 to May 30, 2027
    • Site details revised
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has become the dominant treatment strategy for patients with acute and chronic coronary artery disease (CAD) requiring revascularization. Nonetheless, PCI with stent implantation has some limitations and especially patients with severely calcified coronary lesions (approximately 10-20% of all patients with CAD) have an elevated risk for adverse outcomes, including target lesion failure (TLF) and stent thrombosis (ST). Several dedicated PCI devices have been developed for treatment of severely calcified lesions. Whereas especially two of them have shown promising results in smaller, prospective studies. First, the super high-pressure NC PCI balloon (OPN™ NC, SIS Medical AG, Frauenfeld, Switzerland) has been shown to represent an effective and safe device for lesion preparation. Second, the lately introduced Shockwave intravascular lithotripsy (IVL)™ balloon catheter (Shockwave Medical, Santa Clara, CA, USA) appears to be a safe and efficient alternative device for treatment of calcified coronary lesions. However, it remains unknown, if the OPN™ NC balloon is non-inferior to to IVL regarding lesion preparation and completeness of stent expansion in severely calcified lesions.
Trial Details
NCT Number NCT05346068
Lead Sponsor Luzerner Kantonsspital
Collaborators: Hôpital Fribourgeois, Hamilton General Hospital
Conditions
(from sponsor)		 Coronary Disease, Coronary Artery Disease, Calcific Coronary Arteriosclerosis, Stent Restenosis, Coronary Artery Calcification
Related terms Coronary Artery Disease, Coronary Disease
Enrollment 280 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov