Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients

Sponsor
Wen-huo Chen (Other)
Overall Status
Recruiting
CT.gov ID
NCT05988125
Collaborator
(none)
2,000
6
50.9
333.3
6.5

Study Details

Study Description

Brief Summary

To investigate the real situation of assessment, diagnosis and treatment of acute ischemic stroke patients with endovascular therapy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients is an academic,independent, pragmatic , prospective, multicenter, observational registry study. The acute ischemic stroke patients undergone endovascular therapy will be enrolled in stroke centers. Baseline information and clinical follow-up information at 90 days of stroke onset are collected. Data collected include demographics, comorbidities, pathogenesis, blood pressures, stroke severity on admission, time intervals, reperfusion condition, and functional outcome, et al. The study aims to investigate the real situation of assessment, diagnosis and treatment of acute ischemic stroke patients with endovascular therapy.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients in China
    Actual Study Start Date :
    Jan 1, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Mar 31, 2025

    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.

    Secondary Outcome Measures

    1. Successful reperfusion rate [90 days]

    2. symptomatic intracranial hemorrhage or death within 90 days after stroke onset. [90 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Acute ischemic stroke;

    2. Brain imaging confirmed intracranial large vessel occlusion: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA V4), and posterior cerebral artery (PCA P1);

    3. Initiation of any type of endovascular treatment, including mechanical thrombectomy, aspiration, angioplasty, and stenting;

    4. Informed Consent as documented by signature or fulfilling the criteria for emergency consent/ deferral consent

    Exclusion Criteria:
    1. Acute intracranial haemorrhage

    2. No evidence of large vessel occlusion on digital subtraction angiography.

    3. Patient bedridden or presenting from a nursing home

    4. Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad) -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhangzhou Municipal Hospital Zhangzhou Fujian China 36300
    2 Gansu provincial hospital of TCM Lanzhou Gansu China 730050
    3 Jiamusi Central Hospital Jiamusi Heilongjiang China 154000
    4 Department of Neurology, The First Affiliated Hospital of Nanchang University Nanchang Jiangxi China 330006
    5 Songyuan Jilin Oilfield Hospital SongYuan Jilin China 138000
    6 Shenyang First People's Hospital Shenyang Liaoning China 110091

    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, Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients in China, Zhangzhou Municipal Hospital
    ClinicalTrials.gov Identifier:
    NCT05988125
    Other Study ID Numbers:
    • ETERNITY
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 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, Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients in China, Zhangzhou Municipal Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 14, 2023