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VITUS Post-Market Registry

StatusActive, Not Recruiting
PhaseNot specified
SponsorOrbusNeich
Started
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Record History

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  1. Enrollment target: 284 to 283v11
  2. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion pushed from Apr 2027 to Jun 2027
    • Study completion pushed from Apr 2029 to Jun 2029
    • Site details revised at 13 of 13 sites
    v10
  3. Study sites: 12 to 13v9
  4. Study sites: 11 to 12v8
  5. Study sites: 9 to 11v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 2 to 9v6
  2. Study sites: 1 to 2v5
  3. Re-verified, no change to tracked fieldsv4
  4. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Mar 2027 to Apr 2027
    • Study completion date: Mar 2029 to Apr 2029
    • Start date changed from estimate of Apr 2025 to May 22, 2025
  5. Primary endpoints revised (3)
    • Secondary endpoints revised (12)
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To collect post marketing surveillance data on consecutive patients with peripheral arterial occlusive disease (PAOD) intended to be or treated by the VITUS peripheral drug-coated dilatation catheter when used according to the Instructions for Use and treating physician decision. Data will be collected in order to assess the long-term safety and performance of the VITUS peripheral drug-coated dilatation catheter in routine clinical practice.
Trial Details
NCT Number NCT06832631
Lead Sponsor OrbusNeich
Collaborators: Eucatech AG, Centre Européen de Recherche Cardiovasculaire
Conditions
(from sponsor)		 Peripheral Arterial Disease, Peripheral Arterial Occlusive Disease
Related terms Peripheral Arterial Disease, Peripheral Arterial Occlusive Disease 1
Enrollment 283 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov