Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)

Study acronym: SUPPORT II
StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Study sites: 24 to 25
  2. Site details revised at 7 of 24 sites
  3. Trial sites expanded: 19 → 24 locations
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 1 entry
  4. Site details revised at 2 of 19 sitesv9
  5. Site details revised at 2 of 19 sitesv8
  6. Site details revised at 4 of 19 sitesv7
  7. Trial sites expanded: 14 → 19 locationsv6
  8. Trial sites expanded: 11 → 14 locationsv5
  9. Primary completion pushed from Apr 2027 to Nov 2027v4 Show 4 more changesShow less
    • Recruitment opened
    • Trial sites expanded: 7 → 11 locations
    • Study completion pushed from Jul 2027 to Nov 2027
    • Start date changed from estimate of Apr 2026 to May 11, 2026
  10. Start date: Feb 2026 to Apr 2026
    • Trial sites expanded: 0 → 7 locations
    v3
  11. Study title shortened, about 1 wordv2
  12. Study First Submitted
  • 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 objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. Eligible patients will be randomized to undergo HRPCI with either the Supira System (investigational device) or the commercially available Impella systems (comparator device).
Trial Details
NCT Number NCT07296744
Lead Sponsor Supira Medical
Conditions
(from sponsor)		 Coronary Artery Disease, High Risk Percutaneous Coronary Intervention, Interventional Cardiology, Mechanical Circulatory Support
Related terms Coronary Artery Disease
Enrollment 358 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov