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

October 5, 2023 updated by: Wen-huo Chen

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1196

Contacts and Locations

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

Study Locations

  • China
    • Fujian
      • Zhangzhou, Fujian, China, 363000
        • Zhangzhou Municipal Hospital

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

Patients with acute ischemic stroke caused by anterior circulation intracranial large vessel occlusion and receiving EVT were included.

Description

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.

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
Baseline CT/magnetic resonance and CT angiography/magnetic resonance angiography imaging, digital subtraction angiography
Time Frame: 90 days
Radiological assessment included ASPECTS ，location of occlusion site, presence of underlying ICAS ，or exist microcatheter "First-Pass Effect".
90 days
Successful reperfusion
Time Frame: 90 days
Successful reperfusion was defined as eTICI ≥2b
90 days

Collaborators and Investigators

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

Sponsor

Wen-huo Chen

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)

November 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A "Real world" study-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

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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