Ischemic StrokeNCT02419781
Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan RCT
A study testing Rescue endovascular therapy and No endovascular therapy in people with Ischemic Stroke, run by Shinichi Yoshimura at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Rescue endovascular therapy and No endovascular therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2014to Jul 2017
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Randomized Controlled Trial
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.
- Conditions
- Ischemic Stroke
- Being tested
- Rescue endovascular therapy, No endovascular therapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rescue endovascular therapyProcedure or surgery
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 therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group with endovascular treatment | Active comparator | Group with additional endovascular treatment Receives: Procedure: Rescue endovascular therapy |
| Group without endovascular treatment | Active comparator | Group without additional endovascular treatment Receives: Procedure: No endovascular therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of modified Rankin Scale shift analysis at 90 days after onset
Measured: 90 days
Secondary outcomes (5)
The rate of mRS 0-2 at 90 days (+/- 10 days) after onset
Measured: 90 days
Death within 90 days (+/- 10 days) after onset
Measured: 90 days
Revascularization rates of the target vessel at 72 hours (+/- 8 hours) after onset
for CT angiography or MR angiography
Measured: 72 hours
Symptomatic intracranial hemorrhage within 72 hours (+/- 8 hours) after onset
Measured: 72 hours
The difference of NIHSS score between pre-treatment and at 72 hours (+/- 8 hours) after onset
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2017
- Study completionJul 2017
Why it stopped: Evidence of thrombectomy for acute stroke was established
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shinichi Yoshimura
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shinichi Yoshimura, Hyogo Medical University
- Investigators
- Shinichi Yoshimura, MD, PhD, Principal investigator, Hyogo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419781
- Sponsor's protocol ID
- UMIN000015272
- Status last verified
- Feb 2018
- First submitted
- 19 Jan 2015
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roaldsen MB, Jusufovic M, Berge E, Lindekleiv H. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD007574. doi: 10.1002/14651858.CD007574.pub3.
PubMed 34125952
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. 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 Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02419781
- Acronym / sponsor ID
- UMIN000015272
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Evidence of thrombectomy for acute stroke was established
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Shinichi YoshimuraUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jul 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with endovascular treatment | Active comparator | Procedure: Rescue endovascular therapyGroup with additional endovascular treatment |
| Group without endovascular treatment | Active comparator | Procedure: No endovascular therapyGroup without additional endovascular treatment |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| Rescue endovascular therapyendovascular 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 | Procedure or surgery | Group with endovascular treatment |
| No endovascular therapy | Procedure or surgery | Group without endovascular treatment |
Primary outcome
Assessment of modified Rankin Scale shift analysis at 90 days after onset
Time frame: 90 days
5 secondary outcomes
The rate of mRS 0-2 at 90 days (+/- 10 days) after onset
Time frame: 90 days
Death within 90 days (+/- 10 days) after onset
Time frame: 90 days
Revascularization rates of the target vessel at 72 hours (+/- 8 hours) after onset
Time frame: 72 hours
Symptomatic intracranial hemorrhage within 72 hours (+/- 8 hours) after onset
Time frame: 72 hours
The difference of NIHSS score between pre-treatment and at 72 hours (+/- 8 hours) after onset
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: Evidence of thrombectomy for acute stroke was established). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Derived from this study: PubMed 34125952Roaldsen MB, Jusufovic M, Berge E, Lindekleiv H. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD007574. doi: 10.1002/14651858.CD007574.pub3.
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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?
A study testing Rescue endovascular therapy and No endovascular therapy in people with Ischemic Stroke, run by Shinichi Yoshimura 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 8 inclusion and 14 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: stopped early, as of the sponsor's last update on 27 Feb 2018. 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 was stopped early (reason given: Evidence of thrombectomy for acute stroke was established). Results are not available in the source record.
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?
Assessment of modified Rankin Scale shift analysis at 90 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 NCT02419781, which also lists 1 linked publication.
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 27 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.