Recovery by Endovascular Salvage for Cerebral Ultra-acute... | NCT02419781

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

NCT02419781

Sponsor

Shinichi Yoshimura

Status

Terminated

Last Update Posted

Feb 27, 2018Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Ischemic Stroke

Interventions

Rescue endovascular therapy
No endovascular therapy

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Evidence of thrombectomy for acute stroke was established

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Mar 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Jan 19, 2015

First Submission Date that Met QC Criteria

Apr 14, 2015

First Posted Date

Apr 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2018

Last Update Posted Date

Feb 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group with endovascular treatment	Active Comparator	Group with additional endovascular treatment	Procedure: Rescue endovascular therapy
Group without endovascular treatment	Active Comparator	Group without additional endovascular treatment	Procedure: No endovascular therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rescue endovascular therapy	Procedure	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

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

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases