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

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

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.

Study Overview

• Status: Terminated
• Conditions: Ischemic Stroke
• Intervention / Treatment: Procedure: Rescue endovascular therapy; Procedure: No endovascular therapy

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Hyogo
    • Nishinomiya, Hyogo, Japan, 883-8501
      • Hyogo College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group with endovascular treatment; Group with additional endovascular treatment	Procedure: Rescue endovascular therapy; 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
Active Comparator: Group without endovascular treatment; Group without additional endovascular treatment	Procedure: No endovascular therapy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shinichi Yoshimura
• Investigators: Principal Investigator: Shinichi Yoshimura, MD, PhD, Hyogo College of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: January 19, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Stroke; Ischemic Stroke; Embolism
• Other Study ID Numbers: UMIN000015272