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

Not Applicable

Terminated

• Conditions: Ischemic Stroke
• Interventions: Procedure: Rescue endovascular therapy; Procedure: No endovascular therapy

• Registration Number: NCT02419781
• Lead Sponsor: Shinichi Yoshimura

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-17
• Primary Completion: 2017-03
• Study Completion: 2017-07
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-02-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group with endovascular treatment	Rescue endovascular therapy	Group with additional endovascular treatment
Group without endovascular treatment	No endovascular therapy	Group without additional endovascular treatment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The difference of NIHSS score between pre-treatment and at 72 hours (+/- 8 hours) after onset	72 hours
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	for CT angiography or MR angiography
Symptomatic intracranial hemorrhage within 72 hours (+/- 8 hours) after onset	72 hours

Trial Locations

Locations (1)

Hyogo College of Medicine; 🇯🇵 Nishinomiya, Hyogo, Japan