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Endovascular Treatment for AIS in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry

Sponsor
Wen-huo Chen (Other)
Overall Status
Completed
CT.gov ID
NCT06078917
Collaborator
(none)
1,196
Enrollment
1
Location
20.9
Actual Duration (Months)
57.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate the Endovascular Treatment difference between Chinese city and country hospital.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Endovascular Treatment for AIS in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry is an academic , independent, pragmatic , prospective , multicenter , observational registry study . Patients with acute ischemic stroke caused by anterior circulation intracranial large vessel occlusion and receiving EVT were included. Patients were divided into primary stroke center (county hospital) and senior stroke center (city hospital) groups. Acute ischemic stroke (AIS) workflow, EVT procedural details and clinical outcome were compared in two groups. The aim of the study was to explore the EVT difference in Chinese city and county hospital.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1196 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Endovascular Treatment for Acute Ischemic Stroke in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry
    Actual Study Start Date :
    Nov 1, 2021
    Actual Primary Completion Date :
    Dec 31, 2022
    Actual Study Completion Date :
    Jul 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. The modified Rankin Scale score at 90 days [90 days]

      The range of the modified Rankin Scale is from 0 to 6. A higher score indicates a worse outcome. 0-No symptoms; 1-No significant disability; 2-Slight disability; 3-Moderate disability; 4-Moderately severe disability; 5-Severe disability; 6-Dead.

    2. Baseline CT/magnetic resonance and CT angiography/magnetic resonance angiography imaging, digital subtraction angiography [90 days]

      Radiological assessment included ASPECTS ，location of occlusion site, presence of underlying ICAS ，or exist microcatheter "First-Pass Effect".

    3. Successful reperfusion [90 days]

      Successful reperfusion was defined as eTICI ≥2b

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    (1) age ≥18 years; (2) diagnosis of AIS caused by imaging-confirmed intracranial LVO, including isolated cervical internal carotid artery or tandem occlusion, intracranial internal carotid artery, middle cerebral artery (M1/M2), anterior cerebral artery (A1/A2); (3) initiation of any type of EVT, including mechanical thrombectomy, emergent angioplasty via balloon or/and stent; (4).Onset-to-presentation time with 24 hours; (5).Patients whose onset-to-presentation time surpass 6 hours should had CTP and fulfill with DAWN[6] or DEFUSE's[7] criteria.

    Exclusion Criteria:

    (1) Without follow up outcome; (2) posterior circulation stroke;(3)no evidence of LVO on angiogram.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhangzhou Municipal Hospital Zhangzhou Fujian China 363000

    Sponsors and Collaborators

    • Wen-huo Chen

    Investigators

    • Principal Investigator: Wen-huo Chen, bachelor, Zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wen-huo Chen, Endovascular Treatment for Acute Ischemic Stroke in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry, Zhangzhou Municipal Hospital
    ClinicalTrials.gov Identifier:
    NCT06078917
    Other Study ID Numbers:
    • A "Real world" study-ETERNITY
    First Posted:
    Oct 12, 2023
    Last Update Posted:
    Oct 12, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wen-huo Chen, Endovascular Treatment for Acute Ischemic Stroke in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry, Zhangzhou Municipal Hospital
    Endovascular Treatment
    acute ischemic stroke
    Additional relevant MeSH terms:
    Ischemic Stroke

    Study Results

    No Results Posted as of Oct 12, 2023