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Clinical Trials/NCT05779215
NCT05779215
Recruiting
N/A

The Multicenter, Prospective, Real-world Registry of Acute Ischemic Stroke With Large- or Medium-vessel Occlusion

Xuanwu Hospital, Beijing1 site in 1 country50,000 target enrollmentApril 25, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Ischemic Stroke
Sponsor
Xuanwu Hospital, Beijing
Enrollment
50000
Locations
1
Primary Endpoint
modified Rankin Scale (mRS) score
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This study is designed to observe the treatment options in real-world clinical practice as well as the safety and efficacy of different treatment strategies.

Detailed Description

LOMEVO is a prospective, multicenter, real-world registry lasting for 10 years. A total of 50000 patients with large- or medium-vessel occlusion will be enrolled at approximately 30 centers around China.

Registry
clinicaltrials.gov
Start Date
April 25, 2023
End Date
December 30, 2032
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Junwei Hao, MD

Director of Neurology Department

Xuanwu Hospital, Beijing

Eligibility Criteria

Inclusion Criteria

  • The clinical diagnosis is acute ischemic stroke with large- or medium- vessel occlusion (the criteria followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018)
  • Informed consent from the patient or surrogate

Exclusion Criteria

  • No additional exclusion criteria

Outcomes

Primary Outcomes

modified Rankin Scale (mRS) score

Time Frame: 90±7 days

Ordinal distribution of mRS at 90±7 days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

Secondary Outcomes

  • mRS 0-3(90±7 days)
  • Excellent functional outcome(90±7 days)
  • Change of National Institutes of Health Stroke Scale (NIHSS)(7 days)
  • Door-to-Puncture Time (DPT)(24 hours)
  • Good functional outcome(90±7 days)
  • Onset-to-recanalization time(24 hours)
  • Symptom-to-thrombolysis time (STT)(24 hours)
  • Door-to-Needle Time (DNT)(24 hours)
  • Door-to-Recanalization Time (DRT)(24 hours)
  • Puncture-to-recanalization time(24 hours)

Study Sites (1)

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