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

Primary Purpose

Ischemic Stroke

Status

Terminated

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

Rescue endovascular therapy

No endovascular therapy

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Hyogo College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group with endovascular treatment

Group without endovascular treatment

Arm Description

Group with additional endovascular treatment

Group without additional endovascular treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

for CT angiography or MR angiography

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

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

Full Information

NCT ID

NCT02419781

First Posted

January 19, 2015

Last Updated

February 26, 2018

Sponsor

Shinichi Yoshimura

1. Study Identification

Unique Protocol Identification Number

NCT02419781

Brief Title

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

Official Title

Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Terminated

Why Stopped

Evidence of thrombectomy for acute stroke was established

Study Start Date

October 2014 (undefined)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Shinichi Yoshimura

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group with endovascular treatment

Arm Type

Active Comparator

Arm Description

Group with additional endovascular treatment

Arm Title

Group without endovascular treatment

Arm Type

Active Comparator

Arm Description

Group without additional endovascular treatment

Intervention Type

Procedure

Intervention Name(s)

Rescue endovascular therapy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

No endovascular therapy

Primary Outcome Measure Information:

Title

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

Time Frame

90 days

Secondary Outcome Measure Information:

Title

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

Time Frame

90 days

Title

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

Time Frame

90 days

Title

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

Description

for CT angiography or MR angiography

Time Frame

72 hours

Title

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

Time Frame

72 hours

Title

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

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shinichi Yoshimura, MD, PhD

Organizational Affiliation

Hyogo Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hyogo College of Medicine

City

Nishinomiya

State/Province

Hyogo

ZIP/Postal Code

883-8501

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

34125952

Citation

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.

Results Reference

derived

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

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