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Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function

Study acronym: PROTECT IV
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Mar 2026 → Oct 2026
See other at-risk trials from Abiomed Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Mar 2026 to Oct 2026
    • Trial sites expanded: 99 → 110 locations
    • Secondary endpoints: 8 to 7
    v42
  2. Study sites: 102 to 99v41
  3. 2 versions Re-verified since Jul 17, 2025, no change to tracked fieldsv39-v40
  4. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 134 to 102
    v38
  5. Site details revised at 1 of 134 sitesv37
Show 35 earlier versionsHide 35 earlier versions
  1. Study sites revised (134)v36
  2. Site details revised at 2 of 134 sitesv35
  3. Site details revised at 5 of 134 sitesv34
  4. Study sites: 132 to 134v33
  5. Study sites: 131 to 132v32
  6. Study sites: 127 to 131v31
  7. Study sites: 124 to 127v30
  8. Study sites: 123 to 124v29
  9. Site details revised at 2 of 123 sitesv28
  10. Site details revised at 1 of 123 sitesv27
  11. Site details revised at 1 of 123 sitesv26
  12. Site details revised at 6 of 123 sites
    • Study description expanded, about 5 words
    v25
  13. Primary endpoint revisedv24 Show 5 more changesShow less
    • Study sites: 115 to 123
    • Primary completion date: Sep 2025 to Mar 2026
    • Study completion date: Sep 2027 to Oct 2027
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints revised (8)
  14. Primary completion date: Mar 2024 to Sep 2025
    • Study sites: 114 to 115
    • Study completion date: Mar 2026 to Sep 2027
    v23
  15. Site details revised at 3 of 114 sitesv22
  16. Study sites: 112 to 114v21
  17. Site details revised at 4 of 112 sitesv20
  18. Study sites: 109 to 112v19
  19. Site details revised at 6 of 109 sitesv18
  20. Study sites: 105 to 109v17
  21. Study sites: 102 to 105v16
  22. Study sites: 98 to 102v15
  23. Study sites: 94 to 98v14
  24. Study sites: 78 to 94v13
  25. Study sites: 71 to 78v12
  26. Primary endpoint revisedv11 Show 4 more changesShow less
    • Study sites: 56 to 71
    • Eligibility criteria expanded, about 168 words
    • Secondary endpoints revised (8)
    • Study description expanded, about 3 words
  27. Study sites: 49 to 56v10
  28. Study sites: 40 to 49v9
  29. Study sites: 31 to 40v8
  30. Study sites: 28 to 31v7
  31. Study sites: 23 to 28v6
  32. Study sites: 14 to 23v5
  33. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2021 to Apr 13, 2021
    • Site details revised at 14 of 14 sites
    v4
  34. Start date: Mar 2021 to Apr 2021
    • Study sites revised (14)
    v3
  35. Study sites: 0 to 14v2
  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.
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care.
Trial Details
NCT Number NCT04763200
Lead Sponsor Abiomed Inc.
Conditions
(from sponsor)		 Left Ventricular Dysfunction, Coronary Artery Disease
Related terms Anterior Wall Myocardial Infarction, Cardiovascular Diseases, Coronary Artery Disease, Heart Diseases, Inferior Wall Myocardial Infarction, Myocardial Infarction, Myocardial Ischemia, Non-ST Elevated Myocardial Infarction, Ventricular Dysfunction, Left
Enrollment 1,252 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov