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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04752735
Other study ID # y (2021)013
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 22, 2021
Est. completion date February 8, 2023

Study information

Verified date February 2023
Source General Hospital of Shenyang Military Region
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date February 8, 2023
Est. primary completion date February 8, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age: = 18; - Ischemic stroke confirmed by head CT or MRI; - Patients receiving endovascular treatment; - First ever stroke or mRS=2 after previous disease; - Complete and clear pre- and post-operative DSA images are available Exclusion Criteria: - Imaging data not qualified for evaluation; - Absence of important clinical data; - The first 50 patients receiving endovascular treatment in a single centerr.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
endovascular treatment
all enrolled patients must receive endovascular treatment.

Locations

Country Name City State
China Department of Neurology, General Hospital of Northern Theater Command Shenyang

Sponsors (1)

Lead Sponsor Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with modified Rankin Score (mRS) 0 to 2 the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome Day 90
Secondary Changes in National Institute of Health stroke scale (NIHSS) the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome Day 2, 7, 14
Secondary Proportion of patients with modified Rankin Score 0 to 2 Proportion of patients with modified Rankin Score 0 to 2 Day180, 360
Secondary Distribution of modified Rankin Score Distribution of modified Rankin Score after treatment Day 90, 180, 360
Secondary Proportion of symptomatic intracranial hemorrhage (sICH) sICH was defined as 4 or more increase in NIHSS caused by hemorrhage 48 hours
Secondary Proportion of intraparenchymal hemorrhage (PH1 and PH2) Proportion of intraparenchymal hemorrhage (PH1 and PH2) after treatment 48 hours
Secondary Proportion of death death due to any cause Day 7
Secondary Changes in cerebral edema edema is determined by middle shift. 48 hours, 7 days
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