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A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke

Sponsor
Changhai Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05864638
Collaborator
(none)
5,000
Enrollment
63.7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The OCEAN-AIS-EVT-Registry is a multicenter, observational, registry study, and aims to assess the safety and outcome of endovascular treatment for acute ischemic stroke in real clinical practice.

    The primary endpoint is functional outcome, defined as a shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±14 days).

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Other
    Official Title:
    Oriental Collaboration Group on Emerging Advanced Therapy for Neurovascular Diseases Consortium-Acute Ischemic Stroke EndoVascular Therapy: a Multicenter REGISTRY Study (OCEAN-AIS-EVT REGISTRY)
    Anticipated Study Start Date :
    May 10, 2023
    Anticipated Primary Completion Date :
    Aug 30, 2028
    Anticipated Study Completion Date :
    Aug 31, 2028

    Outcome Measures

    Primary Outcome Measures

    1. Functional outcome [90days]

      Shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±7 days). The value range 0-6: higher scores mean a worse outcome.

    Secondary Outcome Measures

    1. Dichotomized modified Rankin scale (mRS) [90days]

      Dichotomized modified Rankin scale (mRS) at 90 days after the procedure (0-1 versus 2-6, 0-2 versus 3-6, 0-3 versus 4-6). The value range 0-6: higher scores mean a worse outcome.

    2. NIHSS at 24 hours [24 hours post treatment]

      Change in stroke severity (NIHSS score) at 24 hours post treatment. The value range 0-42: higher scores mean a worse outcome.

    3. NIHSS at 7 days [7 days post procedure]

      Change in stroke severity (NIHSS score) at 7 days post procedure. The value range 0-42: higher scores mean a worse outcome.

    4. Reperfusion outcome [Immediately post-procedure]

      Reperfusion outcome (eTICI 2b or greater) in final angiogram. The expanded treatment in cerebral infarction (eTICI) score is a modified from the modified treatment in cerebral infarction (mTICI) and thrombolysis in cerebral infarction (TICI) scales. The value range 0-3: higher scores mean a better outcome.

    5. Reperfusion outcome [7 days post procedure]

      Reperfusion outcome (eTICI 2b or greater) at 7 days post procedure. The expanded treatment in cerebral infarction (eTICI) score is a modified from the modified treatment in cerebral infarction (mTICI) and thrombolysis in cerebral infarction (TICI) scales. The value range 0-3: higher scores mean a better outcome.

    Other Outcome Measures

    1. Death [7 days and 90 days]

      All-cause death

    2. Intracerebral hemorrhage(ICH) [90 days]

      symptomatic ICH, asymptomatic ICH. The Heidelberg bleeding classification categorizes intracranial hemorrhages occurring after ischemic stroke and reperfusion therapy.

    3. Procedure related complication [within 30 days after procedure]

      Procedure related complication

    4. adverse event (Device malfunction ) [within 30 days after procedure]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of AIS with anterior or posterior circulation LVO confirmed by CTA, MRA or DSA;

    • To receive endovascular treatment;

    • Agree to participate in the study and signed informed consent form.

    Exclusion Criteria:
    • This study does not set exclusion criteria

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Changhai Hospital

    Investigators

    • Principal Investigator: Jianimin Liu, M.D., Changhai Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jian-min Liu, Director of Cerebrovascular Disease Center, Changhai Hospital
    ClinicalTrials.gov Identifier:
    NCT05864638
    Other Study ID Numbers:
    • OCEAN-AIS-EVT REGISTRY
    First Posted:
    May 18, 2023
    Last Update Posted:
    May 18, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke
    Cerebral Infarction
    Thrombosis
    Ischemia

    Study Results

    No Results Posted as of May 18, 2023