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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02419781
• Other study ID #: UMIN000015272
• Status: Terminated
• Phase: N/A
• First received: January 19, 2015
• Last updated: February 26, 2018
• Start date: October 2014
• Est. completion date: July 2017

Study information

• Verified date: February 2018
• Source: Hyogo College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: July 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Ischemic Stroke

Intervention

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
• No endovascular therapy

Locations

Country	Name	City	State
Japan	Hyogo College of Medicine	Nishinomiya	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Shinichi Yoshimura

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of modified Rankin Scale shift analysis at 90 days after onset		90 days
Secondary	The rate of mRS 0-2 at 90 days (+/- 10 days) after onset		90 days
Secondary	Death within 90 days (+/- 10 days) after onset		90 days
Secondary	Revascularization rates of the target vessel at 72 hours (+/- 8 hours) after onset	for CT angiography or MR angiography	72 hours
Secondary	Symptomatic intracranial hemorrhage within 72 hours (+/- 8 hours) after onset		72 hours
Secondary	The difference of NIHSS score between pre-treatment and at 72 hours (+/- 8 hours) after onset		72 hours