Clinical trial NCT02419794: Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Registry 2
Official title: Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Registry 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Lead sponsor: Hyogo Medical University
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 2420
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute cerebral large vessel occlusion admitted within 24 hours after onset.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: modified Rankin Scale (mRS) of 0-2 at 90 days (+/- 10 days) after onset
timeFrame: 90 days
Secondary outcomes:
measure: Death within 90 days (+/- 10 day) after the onset
timeFrame: 90 days
measure: modified Rankin Scale (mRS) of 0-1 at 90 days (+/- 10 days) after onset
timeFrame: 90 days
measure: All bleeding within 90 days (+/- 10 days) after onset
timeFrame: 90 days
measure: All intracranial hemorrhage within 90 days (+/- 10 days) after onset
timeFrame: 90 days
measure: Symptomatic intracranial hemorrhage within 90 days (+/- 10 days) after onset
timeFrame: 90 days
Other outcomes:
measure: Symptomatic intracranial hemorrhage within 72 hours (+/- 8 hours) after onset
timeFrame: 72 hours
measure: Reccurrence of stroke within 90 days (+/- 10 days) after onset
timeFrame: 90 days
Locations:
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
Study officials:
affiliation: Hyogo Medical University
name: Shinichi Yoshimura, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tanaka K, Yamagami H, Yoshimoto T, Uchida K, Morimoto T, Toyoda K, Sakai N, Yoshimura S. Endovascular Therapy for Acute Ischemic Stroke in Patients With Prestroke Disability. J Am Heart Assoc. 2021 Aug 3;10(15):e020783. doi: 10.1161/JAHA.121.020783. Epub 2021 Jul 21.
citation: Fujita K, Tanaka K, Yamagami H, Yoshimoto T, Uchida K, Morimoto T, Imamura H, Sakai N, Ohara N, Matsumoto Y, Takeuchi M, Shigeta K, Toyoda K, Yoshimura S. Outcomes of Large Vessel Occlusion Stroke in Patients Aged >/=90 Years. Stroke. 2021 May;52(5):1561-1569. doi: 10.1161/STROKEAHA.120.031386. Epub 2021 Mar 1.
citation: Saito T, Itabashi R, Yazawa Y, Uchida K, Yamagami H, Sakai N, Morimoto T, Yoshimura S; RESCUE-Japan Registry 2 Investigators. Clinical Outcome of Patients With Large Vessel Occlusion and Low National Institutes of Health Stroke Scale Scores: Subanalysis of the RESCUE-Japan Registry 2. Stroke. 2020 May;51(5):1458-1463. doi: 10.1161/STROKEAHA.119.028562. Epub 2020 Apr 16.
citation: Yoshimura S, Sakai N, Uchida K, Yamagami H, Ezura M, Okada Y, Kitagawa K, Kimura K, Sasaki M, Tanahashi N, Toyoda K, Furui E, Matsumaru Y, Minematsu K, Morimoto T. Endovascular Therapy in Ischemic Stroke With Acute Large-Vessel Occlusion: Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism Japan Registry 2. J Am Heart Assoc. 2018 Apr 25;7(9):e008796. doi: 10.1161/JAHA.118.008796.