NCT05092139

Brief Summary

This is a prospective real world registry study, aiming to explore the effectiveness and safety of endovascular treatment of acute ischemic stroke in a Chinese population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 21, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

October 13, 2021

Last Update Submit

March 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with modified Rankin Score 0 to 2

    the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome

    Day 90

Secondary Outcomes (5)

  • Proportion of patients with modified Rankin Score 0 to 1

    Day 90

  • Distribution of modified Rankin Score

    Day 90

  • Changes in National Institute of Health stroke scale (NIHSS)

    24 hours, 48 hours, and 2 weeks

  • Proportion of symptomatic intracranial hemorrhage (sICH)

    48 hours

  • Proportion of death

    7 days

Other Outcomes (4)

  • neuroimaging associated with clinical outcome

    48 hours

  • changes in serum biomarkers

    48 hours

  • dynamic changes of TCD data associated

    24 hours

  • +1 more other outcomes

Interventions

all enrolled patients must receive endovascular treatment

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

acute ischemic stroke with large vessel oclussion

You may qualify if:

  • Age: ≥ 18;
  • Ischemic stroke confirmed by head CT or MRI;
  • Patients receiving endovascular treatment;
  • First ever stroke or pre-stroke mRS≤2;
  • signed informed consent.

You may not qualify if:

  • Prestroke mRS≥3;
  • Other serious illness that would confound the clinical outcome at 90 days;
  • Unavailable neuroimaging data;
  • Other unsuitable conditions judged by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hui-Sheng Chen

Shenyang, Liaoning, 110840, China

Location

Related Publications (1)

  • Liu L, Nguyen TN, Chen HS. Endovascular Treatment for Acute Ischemic Stroke in China: a study protocol for a prospective, national, multi-center, registry study. Front Neurol. 2023 Aug 10;14:1171718. doi: 10.3389/fneur.2023.1171718. eCollection 2023.

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neurology

Study Record Dates

First Submitted

October 13, 2021

First Posted

October 25, 2021

Study Start

January 21, 2022

Primary Completion

January 10, 2025

Study Completion

January 10, 2025

Last Updated

March 18, 2025

Record last verified: 2025-03

Locations