NCT02419794

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

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

Study Start

First participant enrolled

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

2.2 years

First QC Date

January 19, 2015

Last Update Submit

July 19, 2017

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • modified Rankin Scale (mRS) of 0-2 at 90 days (+/- 10 days) after onset

    90 days

Secondary Outcomes (5)

  • Death within 90 days (+/- 10 day) after the onset

    90 days

  • modified Rankin Scale (mRS) of 0-1 at 90 days (+/- 10 days) after onset

    90 days

  • All bleeding within 90 days (+/- 10 days) after onset

    90 days

  • All intracranial hemorrhage within 90 days (+/- 10 days) after onset

    90 days

  • Symptomatic intracranial hemorrhage within 90 days (+/- 10 days) after onset

    90 days

Other Outcomes (2)

  • Symptomatic intracranial hemorrhage within 72 hours (+/- 8 hours) after onset

    72 hours

  • Reccurrence of stroke within 90 days (+/- 10 days) after onset

    90 days

Study Arms (2)

Group with endovascular treatment

Group with additional endovascular treatment

Procedure: endovascular treatment

Group without endovascular treatment

Group without additional endovascular treatment

Interventions

endovascular treatmentPROCEDURE

endovascular treatment for acute ischemic stroke patients with large vessel occlusion

Group with endovascular treatment

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hyogo College of Medicine

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Related Publications (5)

  • Kamogawa N, Tanaka K, Yamagami H, Yoshimoto T, Uchida K, Morimoto T, Imamura H, Sakai N, Ohara N, Matsumoto Y, Takeuchi M, Shigeta K, Toyoda K, Yoshimura S. Outcomes of Symptomatic Anterior Large Vessel Occlusion by Initial Imaging Assessment Using Diffusion-Weighted Imaging Versus Noncontrast Computed Tomography. Stroke Vasc Interv Neurol. 2022 Apr 16;2(5):e000170. doi: 10.1161/SVIN.121.000170. eCollection 2022 Sep.

    PMID: 41584006DERIVED

  • Tanaka K, Yamagami H, Yoshimoto T, Uchida K, Morimoto T, Toyoda K, Sakai N, Yoshimura S. Endovascular Therapy for Acute Ischemic Stroke in Patients With Prestroke Disability. J Am Heart Assoc. 2021 Aug 3;10(15):e020783. doi: 10.1161/JAHA.121.020783. Epub 2021 Jul 21.

    PMID: 34284599DERIVED

  • Fujita K, Tanaka K, Yamagami H, Yoshimoto T, Uchida K, Morimoto T, Imamura H, Sakai N, Ohara N, Matsumoto Y, Takeuchi M, Shigeta K, Toyoda K, Yoshimura S. Outcomes of Large Vessel Occlusion Stroke in Patients Aged >/=90 Years. Stroke. 2021 May;52(5):1561-1569. doi: 10.1161/STROKEAHA.120.031386. Epub 2021 Mar 1.

    PMID: 33641385DERIVED

  • Saito T, Itabashi R, Yazawa Y, Uchida K, Yamagami H, Sakai N, Morimoto T, Yoshimura S; RESCUE-Japan Registry 2 Investigators. Clinical Outcome of Patients With Large Vessel Occlusion and Low National Institutes of Health Stroke Scale Scores: Subanalysis of the RESCUE-Japan Registry 2. Stroke. 2020 May;51(5):1458-1463. doi: 10.1161/STROKEAHA.119.028562. Epub 2020 Apr 16.

    PMID: 32295504DERIVED

  • Yoshimura S, Sakai N, Uchida K, Yamagami H, Ezura M, Okada Y, Kitagawa K, Kimura K, Sasaki M, Tanahashi N, Toyoda K, Furui E, Matsumaru Y, Minematsu K, Morimoto T. Endovascular Therapy in Ischemic Stroke With Acute Large-Vessel Occlusion: Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism Japan Registry 2. J Am Heart Assoc. 2018 Apr 25;7(9):e008796. doi: 10.1161/JAHA.118.008796.

    PMID: 29695384DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Shinichi Yoshimura, MD, PhD

    Hyogo Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 19, 2015

First Posted

April 17, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2016

Study Completion

May 1, 2017

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

JP(1)