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NCT05437055

THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration Tubing

StatusCompleted
PhaseNot applicable
Primary completion
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Record History

All 30 versions: 29 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Results posted: Nov 3, 2026
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints revised (7)
    • Publications: details revised at 1 of 1 entry
  2. Study Identification, Study Status, Oversightv29
  3. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Dec 2024 to Dec 10, 2024
    • Secondary endpoints: details revised at 2 of 7 entries
    v28
  4. Primary endpoints: 2 to 1v27 Show 6 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 275 to confirmed 216
    • Primary completion date changed from estimate of Mar 2025 to Sep 23, 2024
    • Study completion date: Jun 2025 to Dec 2024
    • Secondary endpoints: 6 to 7
    • Site details revised at 32 of 32 sites
  5. Study sites: 30 to 32v26
Show 23 earlier versionsHide 23 earlier versions
  1. Study sites: 29 to 30v25
  2. Study sites: 28 to 29v24
  3. Study sites: 27 to 28v23
  4. Study sites: 26 to 27v22
  5. Study sites: 25 to 26v21
  6. Study sites: 24 to 25v19
  7. Study sites: 23 to 24v18
  8. Study sites: 22 to 23v17
  9. Enrollment target: 160 to 275v16 Show 5 more changesShow less
    • Primary completion date: Mar 2023 to Mar 2025
    • Primary endpoints revised (2)
    • Study sites: 20 to 22
    • Study completion date: Jun 2023 to Jun 2025
    • Secondary endpoints revised (6)
  10. Study sites: 18 to 20v15
  11. Study sites: 16 to 18v14
  12. Study sites: 14 to 16v13
  13. Study sites: 12 to 14v12
  14. Study sites: 11 to 12v11
  15. Study sites: 9 to 11v10
  16. Study sites: 8 to 9v9
  17. Study sites: 7 to 8v8
  18. Study sites: 5 to 7v7
  19. Study sites: 4 to 5v6
  20. Study sites: 3 to 4v5
  21. Study sites: 2 to 3v4
  22. Study sites: 1 to 2
    • Start date changed from estimate of Aug 2022 to Aug 11, 2022
    v3
  23. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Efficacy Endpoint: Angiographic Revascularization
Timeframe: Up to Procedure Completion

Secondary (7)

Efficacy Endpoint: Angiographic Revascularization After First Pass
Efficacy Endpoint: Angiographic Revascularization
Efficacy Endpoint: Time to Revascularization
Efficacy Endpoint: Modified Rankin Scale (mRS)
Safety Endpoint: Rate of Symptomatic Intracranial Hemorrhage (sICH)
Show 2 moreShow less
Safety Endpoint: All-cause Mortality
Safety Endpoint: Serious Adverse Events (SAEs)

Arms and interventions

Single ArmExperimental

Use of Penumbra System including Thunderbolt in patients with acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy

Devices: Mechanical Thrombectomy (Penumbra System with Thunderbolt)

Sites

32 sites in 1 country