Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Registry 2

July 19, 2017 updated by: Shinichi Yoshimura, Hyogo College of Medicine
The aim of this study is to clarify treatment status and clinical results of acute cerebral ischemia after approval of clot retriever in Japan, and also to obtain a basis for comparative studies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2420

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

  • Japan
    • Hyogo
      • Nishinomiya, Hyogo, Japan, 663-8501
        • Hyogo College of Medicine

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Acute cerebral large vessel occlusion admitted within 24 hours after onset.

Description

Inclusion Criteria:

  • Patients admitted from Oct. 1st 2014 to Sep. 30st 2016.
  • Patients who were 20 years and older admitted within 24 hours after onset.
  • The patients with large vessel occlusion (ICA, MCA, VA, BA, PCA).
  • Patients who did not fulfill the criteria of RESCUE-Japan RCT.

Exclusion Criteria:

･Patients who are considered inappropriate to participate in the study are excluded.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group with endovascular treatment
Group with additional endovascular treatment
Procedure: endovascular treatment
endovascular treatment for acute ischemic stroke patients with large vessel occlusion
Group without endovascular treatment
Group without additional endovascular treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
modified Rankin Scale (mRS) of 0-2 at 90 days (+/- 10 days) after onset
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Death within 90 days (+/- 10 day) after the onset
Time Frame: 90 days
90 days
modified Rankin Scale (mRS) of 0-1 at 90 days (+/- 10 days) after onset
Time Frame: 90 days
90 days
All bleeding within 90 days (+/- 10 days) after onset
Time Frame: 90 days
90 days
All intracranial hemorrhage within 90 days (+/- 10 days) after onset
Time Frame: 90 days
90 days
Symptomatic intracranial hemorrhage within 90 days (+/- 10 days) after onset
Time Frame: 90 days
90 days

Other Outcome Measures

Outcome Measure
Time Frame
Symptomatic intracranial hemorrhage within 72 hours (+/- 8 hours) after onset
Time Frame: 72 hours
72 hours
Reccurrence of stroke within 90 days (+/- 10 days) after onset
Time Frame: 90 days
90 days

Collaborators and Investigators

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

Sponsor

Hyogo College of Medicine

Investigators

  • Principal Investigator: Shinichi Yoshimura, MD, PhD, Hyogo College of Medicine

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

October 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

April 14, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 19, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMIN000015273

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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