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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Procedure: Rescue endovascular therapy
* Procedure: No endovascular therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group with endovascular treatment<br>Group with additional endovascular treatment | Procedure: Rescue endovascular therapy<br>* 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<br>|
| Active Comparator: Group without endovascular treatment<br>Group without additional endovascular treatment | Procedure: No endovascular therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of modified Rankin Scale shift analysis at 90 days after onset |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | for CT angiography or MR angiography | 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 |