Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients

October 4, 2024 updated by: Tingyu-Yi

Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients in China

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Zhangzhou, Fujian, China, 36300
        • Recruiting
        • Zhangzhou Municipal Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Recruiting
        • Gansu provincial hospital of TCM
        • Contact:
    • Heilongjiang
      • Jiamusi, Heilongjiang, China, 154000
        • Recruiting
        • Jiamusi Central Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • Department of Neurology, The First Affiliated Hospital of Nanchang University
        • Contact:
    • Jilin
      • SongYuan, Jilin, China, 138000
        • Recruiting
        • Songyuan Jilin Oilfield Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110091
        • Recruiting
        • Shenyang First People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Acute ischemic stroke patients receiving endovascular treatment.

Description

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) -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The modified Rankin Scale score at 90 days
Time Frame: 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.
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Successful reperfusion rate
Time Frame: 90 days
90 days
symptomatic intracranial hemorrhage or death within 90 days after stroke onset.
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tingyu-Yi

Collaborators

The First Affiliated Hospital of Nanchang University
Fujian Medical University Union Hospital
First People's Hospital of Shenyang

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

August 4, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETERNITY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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