Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Registry 2

Ischemic Stroke Clinical Trial

Official title:

Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Registry 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419794
• Other study ID #: UMIN000015273
• Status: Completed
• Phase: N/A
• First received: January 19, 2015
• Last updated: July 19, 2017
• Start date: October 2014
• Est. completion date: May 2017

Study information

• Verified date: July 2017
• Source: Hyogo College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to clarify treatment status and clinical results of acute cerebral ischemia after approval of clot retriever in Japan, and also to obtain a basis for comparative studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2420
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted from Oct. 1st 2014 to Sep. 30st 2016.

• Patients who were 20 years and older admitted within 24 hours after onset.

• The patients with large vessel occlusion (ICA, MCA, VA, BA, PCA).

• Patients who did not fulfill the criteria of RESCUE-Japan RCT.

Exclusion Criteria:

?Patients who are considered inappropriate to participate in the study are excluded.

Related Conditions & MeSH terms

• Embolism
• Ischemic Stroke

Intervention

Procedure:
• endovascular treatment
endovascular treatment for acute ischemic stroke patients with large vessel occlusion

Locations

Country	Name	City	State
Japan	Hyogo College of Medicine	Nishinomiya	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Hyogo College of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptomatic intracranial hemorrhage within 72 hours (+/- 8 hours) after onset		72 hours
Other	Reccurrence of stroke within 90 days (+/- 10 days) after onset		90 days
Primary	modified Rankin Scale (mRS) of 0-2 at 90 days (+/- 10 days) after onset		90 days
Secondary	Death within 90 days (+/- 10 day) after the onset		90 days
Secondary	modified Rankin Scale (mRS) of 0-1 at 90 days (+/- 10 days) after onset		90 days
Secondary	All bleeding within 90 days (+/- 10 days) after onset		90 days
Secondary	All intracranial hemorrhage within 90 days (+/- 10 days) after onset		90 days
Secondary	Symptomatic intracranial hemorrhage within 90 days (+/- 10 days) after onset		90 days