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Support C Post-Market Registry

StatusActive, Not Recruiting
PhaseNot specified
SponsorOrbusNeich
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study sites: 11 to 12v12
  2. Minor Enrollment target: 281 to 282v11
  3. Minor Trial status: Recruiting to Active, Not Recruitingv10 Show 4 more changesShow less
    • Enrollment target: estimated 278 to confirmed 281
    • Primary completion date: May 2027 to Feb 2027
    • Study completion date: Aug 2029 to Feb 2029
    • Site details revised at 11 of 11 sites
  4. Minor Study sites: 10 to 11v9
  5. Minor Study sites: 8 to 10v8
Show 6 earlier versionsHide 6 earlier versions
  1. Minor Study sites: 6 to 8v7
  2. Minor Study sites: 1 to 6v6
  3. Notable Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Apr 2027 to May 2027
    • Study completion date: Jul 2029 to Aug 2029
    • Start date changed from estimate of Jun 2025 to Jul 9, 2025
  4. Notable Start date: Mar 2025 to Jun 2025
    • Primary completion date: Jan 2027 to Apr 2027
    • Study completion date: Apr 2029 to Jul 2029
    v4
  5. Minor Re-verified, no change to tracked fieldsv3
  6. Notable Start date: Dec 2024 to Mar 2025
    • Primary completion date: Oct 2026 to Jan 2027
    • Study completion date: Jan 2029 to Apr 2029
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 coronary heart disease intended to be or treated by the drug eluting Support C PTCA balloon catheter when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Support C Drug Coated Balloon (DCB) in routine clinical practice.
Trial Details
NCT Number NCT06678490
Lead Sponsor OrbusNeich
Collaborators: Eucatech AG, European Cardiovascular Research Center
Conditions
(from sponsor)
Coronary Arteriosclerosis
Related terms Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Heart Diseases, Myocardial Ischemia
Enrollment 282 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov