NCT02419781

Brief Summary

The aim of this study is to clarify the efficacy of the endovascular treatment for acute ischemic stroke patients with large vessel occlusion and are not respond to intravenous recombinant tissue plasminogen activator (rt-PA) therapy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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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
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

2.4 years

First QC Date

January 19, 2015

Last Update Submit

February 26, 2018

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Assessment of modified Rankin Scale shift analysis at 90 days after onset

    90 days

Secondary Outcomes (5)

  • The rate of mRS 0-2 at 90 days (+/- 10 days) after onset

    90 days

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

    90 days

  • Revascularization rates of the target vessel at 72 hours (+/- 8 hours) after onset

    72 hours

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

    72 hours

  • The difference of NIHSS score between pre-treatment and at 72 hours (+/- 8 hours) after onset

    72 hours

Study Arms (2)

Group with endovascular treatment

ACTIVE COMPARATOR

Group with additional endovascular treatment

Procedure: Rescue endovascular therapy

Group without endovascular treatment

ACTIVE COMPARATOR

Group without additional endovascular treatment

Procedure: No endovascular therapy

Interventions

Rescue endovascular therapyPROCEDURE

endovascular treatment using any devises for acute ischemic stroke patients with large vessel occlusion and not respond to intravenous recombinant tissue plasminogen activator (rt-PA) therapy

Group with endovascular treatment
No endovascular therapyPROCEDURE
Group without endovascular treatment

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute ischemic stroke patients who were treated with intravenous rt-PA therapy within 4.5 hours from onset and have persistent occlusion of IC and M1 proximal portion\* confirmed by cerebral angiography.
  • \*: M1 proximal portion means the segment of MCA within 5mm from the internal carotid bifurcation.
  • Patients who can receive endovascular treatment within 8 hours after the onset.
  • Patients whose DWI-ASPECTS was 5 points and more, or CT-ASPECT was 6 points and more just before cerebral angiography.
  • Patients whose NIHSS is between 8 and 29 points.
  • Patients who are between 20 and 85 years.
  • Gender does not matter.
  • Consent of this study participants must be obtained from patients or legal representative in writing.

You may not qualify if:

  • Patients whose neurological symptoms improved and NIHSS is eight points and less after intravenous rt-PA therapy.
  • Patients whose mRS was 3 points and more before the onset. 3)Patients with past history of lumbar puncture or arterial puncture that were difficult of hemostasis.
  • Patients with intracranial tumor
  • Patients with hypersensitivity to contrast agent.
  • Patients with serious renal disease.
  • Patients with malignant tumor.
  • Patients with pregnancy or suspect of pregnancy, or during lactation.
  • Patients with findings of acute myocardial infarction or pericarditis after myocardial infarction.
  • Patients who cannot be followed for 3 months.
  • Patients with past history of cerebral aneurysm, cerebral arteriovenous malformation, cerebral venous thrombosis, or moyamoya disease.
  • Patients with other occlusions besides ICA or M1 proximal portion.
  • Patients with aortic dissection complicating endovascular treatment.
  • Patients with tortuous arteries that prevent the navigation of the device to the target vessel.
  • Patients considered inappropriate to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hyogo College of Medicine

Nishinomiya, Hyōgo, 883-8501, Japan

Location

Related Publications (1)

  • Roaldsen MB, Jusufovic M, Berge E, Lindekleiv H. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD007574. doi: 10.1002/14651858.CD007574.pub3.

    PMID: 34125952DERIVED

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
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 19, 2015

First Posted

April 17, 2015

Study Start

October 1, 2014

Primary Completion

March 1, 2017

Study Completion

July 1, 2017

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

JP(1)