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INSPIRE Pipeline™ Shield Post Approval Study

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 2026 → Jan 2027
See other at-risk trials from Medtronic Neurovascular Clinical Affairs

Record History

  1. Primary completion pushed from Jul 2026 to Jan 2027v21
  2. Primary completion date: Mar 2026 to Jul 2026v20
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 250 to confirmed 246
    • Site details revised at 16 of 16 sites
    v19
  4. Primary completion date: Mar 2025 to Mar 2026
    • Enrollment target: 203 to 250
    • Study completion date: Mar 2027 to Apr 2028
    • Site details revised at 1 of 16 sites
    v18
  5. Site details revised at 1 of 16 sitesv17
Show 15 earlier versionsHide 15 earlier versions
  1. Study sites: 15 to 16v16
  2. Study sites: 14 to 15v15
  3. Study sites: 13 to 14v14
  4. Site contacts updated at 1 of 13 sitesv13
  5. Study sites: 12 to 13v12
  6. Site contacts updated at 1 of 12 sitesv11
  7. Study sites: 11 to 12v10
  8. Study sites: 10 to 11v9
  9. Study sites: 8 to 10v8
  10. Study sites: 7 to 8v7
  11. Primary completion date: Dec 2023 to Mar 2025
    • Study sites: 6 to 7
    • Study completion date: Dec 2025 to Mar 2027
    v6
  12. Study sites: 3 to 6v5
  13. Study sites: 2 to 3v4
  14. Start date: Nov 18, 2021 to Dec 20, 2021
    • Study sites: 1 to 2
    v3
  15. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2021 to Nov 18, 2021
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of the Pipeline™ Flex Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Shield PAS") is to collect on-label use data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Flex Embolization Device with Shield Technology™ ("Pipeline™ Shield Device") in a real-world post approval setting within the United States.
Trial Details
NCT Number NCT05071963
Lead Sponsor Medtronic Neurovascular Clinical Affairs
Conditions
(from sponsor)		 Intracranial Aneurysm
Related terms Intracranial Aneurysm
Enrollment 246 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov