Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke With Mild Symptoms

August 25, 2020 updated by: Shanghai East Hospital

Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke With Mild Symptoms After Imaging Selection

Mechanical thrombectomy(MT) has been recommended in patients with acute large vessel occlusion stroke(LVO) , especially for those with National Institutes of Health Stroke Scale (NIHSS) score ≥6. However, it is still unclear if patients with minor strokes and LVO also benefit from MT.The aim of this study was to evaluate the safety and efficacy of MT for acute LVO and mild symptoms.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

This is a prospective cohort study of patients with with mild ischemic stroke (NIHSS Score <6) and LVO. Patients were divided into 2 groups: MT or medical management.Baseline data and clinical outcomes were compared. A independent clinical outcome was defined as a modified Rankin Scale score of 0 to 2 at 90 days. A excellent clinical outcome was defined as a modified Rankin Scale score of 0 to 1 at 90 days. Symptomatic intracranial hemorrhage(sICH) was the safety outcome.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

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

    • Shanghai
      • Shanghai, Shanghai, China, 200123
        • Gang Li

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. acute ischemic stroke within 24 hours of symptom onset presenting cortical symptoms (such as aphasia, somnolence,slow-minded,etc.) or vertigo with bilateral pathological signs;
  2. age≥18 years old;
  3. the NIHSS score before evaluation of thrombectomy<6;
  4. large artery occlusion including Middle cerebral artery M1, proximal M2 segment, intracranial internal carotid artery and infarct core volume≤50ml and mismatch ratio>1.8 or basilar artery and posterior cerebral artery P1 occlusion

Exclusion Criteria:

  1. Patients without prior functional independence (mRS score of >2)
  2. Patients in intervention group with occlusive artery spontaneous recanalization in digital subtraction angiography
  3. patients in control group with neurological worsening and received rescue thrombectomy

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
patients in this group will receive mechanical thrombectomy and standardized drug treatment of acute ischemic stroke
Solitaire stent and manual aspiration thrombectomy were performed as the first-line endovascular treatment
No Intervention: control group
patients in this group will receive standardized drug treatment of acute ischemic stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin Scale(mRS) score of 0 to 2
Time Frame: 90 days
independent outcome at 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin Scale(mRS) score of 0 to 1
Time Frame: 90 days
excellent outcome at 90 days
90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic intracranial haemorrhage transformation
Time Frame: 36 hours
Symptomatic intracranial haemorrhage (sICH) transformation was defined according to European Cooperative Acute Stroke Study (ECASS)-III criteria
36 hours

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Gang Li, Shanghai East Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2016

Primary Completion (Actual)

March 15, 2020

Study Completion (Actual)

June 20, 2020

Study Registration Dates

First Submitted

August 22, 2020

First Submitted That Met QC Criteria

August 25, 2020

First Posted (Actual)

August 26, 2020

Study Record Updates

Last Update Posted (Actual)

August 26, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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