Ischemic StrokeNCT02419794

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

An observational study of Ischemic Stroke, run by Hyogo Medical University at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Ischemic Stroke
What is being tested?: endovascular treatment
Type of treatment: Surgery or procedure
How many people: 2,420 participants
Where: 1 siteJapan
Study dates: Oct 2014to May 2017
How long will I take part?: 90 Days
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Acute cerebral large vessel occlusion admitted within 24 hours after onset.

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

Hyogo College of Medicine
Nishinomiya, Hyōgo, 663-8501

Other trials in Japan

About this study

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.

Conditions: Ischemic Stroke
Being tested: endovascular treatment
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

endovascular treatmentProcedure or surgery
endovascular treatment for acute ischemic stroke patients with large vessel occlusion

Study groups in NCT02419794
Study group	Role	What they receive
Group with endovascular treatment		Group with additional endovascular treatment Receives: Procedure: endovascular treatment
Group without endovascular treatment		Group without additional endovascular treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

modified Rankin Scale (mRS) of 0-2 at 90 days (+/- 10 days) after onset
Measured: 90 days

Secondary outcomes (5)

Death within 90 days (+/- 10 day) after the onset
Measured: 90 days
modified Rankin Scale (mRS) of 0-1 at 90 days (+/- 10 days) after onset
Measured: 90 days
All bleeding within 90 days (+/- 10 days) after onset
Measured: 90 days
All intracranial hemorrhage within 90 days (+/- 10 days) after onset
Measured: 90 days
Symptomatic intracranial hemorrhage within 90 days (+/- 10 days) after onset
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014May 2017

First posted17 Apr 2015 (estimated)
Study startOct 2014
Primary completionDec 2016
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Ischemic StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 2,420 participants (actual)
Target duration: 90 Days

IDs, dates and publications

ClinicalTrials.gov ID: NCT02419794
Sponsor's protocol ID: UMIN000015273
Status last verified: Jul 2017
First submitted: 19 Jan 2015
Last updated: 21 Jul 2017
Results posted: No
Data monitoring committee: Yes

Publications

Kamogawa N, 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 Symptomatic Anterior Large Vessel Occlusion by Initial Imaging Assessment Using Diffusion-Weighted Imaging Versus Noncontrast Computed Tomography. Stroke Vasc Interv Neurol. 2022 Apr 16;2(5):e000170. doi: 10.1161/SVIN.121.000170. eCollection 2022 Sep.
PubMed 41584006
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.
PubMed 34284599
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.
PubMed 33641385
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.
PubMed 32295504
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.
PubMed 29695384

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Registry 2
ClinicalTrials.gov ID: NCT02419794
Acronym / sponsor ID: UMIN000015273
Conditions: Ischemic Stroke
Study type: Observational
Recruitment status: Completed
Enrolment: 2,420 participants (actual)
Lead sponsor: Hyogo Medical UniversityUniversity, hospital or other
Study start: Oct 2014
Primary completion: Dec 2016 (actual)
Study completion: May 2017 (actual)
First posted: 17 Apr 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 90 Days
Number of arms: 2

Arm	Type	Receives
Group with endovascular treatment	–	Procedure: endovascular treatmentGroup with additional endovascular treatment
Group without endovascular treatment	–	–Group without additional endovascular treatment

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Acute cerebral large vessel occlusion admitted within 24 hours after onset.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
endovascular treatmentendovascular treatment for acute ischemic stroke patients with large vessel occlusion	Procedure or surgery	Group with endovascular treatment

Primary outcome

modified Rankin Scale (mRS) of 0-2 at 90 days (+/- 10 days) after onset
Time frame: 90 days

5 secondary outcomes

Death within 90 days (+/- 10 day) after the onset
Time frame: 90 days
modified Rankin Scale (mRS) of 0-1 at 90 days (+/- 10 days) after onset
Time frame: 90 days
All bleeding within 90 days (+/- 10 days) after onset
Time frame: 90 days
All intracranial hemorrhage within 90 days (+/- 10 days) after onset
Time frame: 90 days
Symptomatic intracranial hemorrhage within 90 days (+/- 10 days) after onset
Time frame: 90 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
Derived from this study: PubMed 41584006Kamogawa N, 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 Symptomatic Anterior Large Vessel Occlusion by Initial Imaging Assessment Using Diffusion-Weighted Imaging Versus Noncontrast Computed Tomography. Stroke Vasc Interv Neurol. 2022 Apr 16;2(5):e000170. doi: 10.1161/SVIN.121.000170. eCollection 2022 Sep.
Derived from this study: PubMed 34284599Tanaka 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.
Derived from this study: PubMed 33641385Fujita 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.
Derived from this study: PubMed 32295504Saito 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.
Derived from this study: PubMed 29695384Yoshimura 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.

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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shinichi Yoshimura, MD, PhD principal investigator

Hyogo Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke, run by Hyogo Medical University at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified Rankin Scale (mRS) of 0-2 at 90 days (+/- 10 days) after onset (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02419794, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.