Mechanical ThrombectomyNCT03702413
Randomized Controlled Trial of Endovascular Therapy for Acute Large Vessel Occlusion With Large Ischemic Core
A study testing Endovascular treatment in people with Mechanical Thrombectomy and Large Ischemic Core, run by Hyogo Medical University at 1 site in Japan.
Trial summary
RESCUE-Japan LIMIT(Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism Japan Large IscheMIc core Trial) is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to compare the effectiveness of endovascular treatment as compared to best medical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Thrombectomy, Large Ischemic Core
- What is being tested?
- Endovascular treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteJapan
- Study dates
- 30 Nov 2018to 30 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute cerebral infarction
- Age ≥ 18
- NIHSS ≥ 6
- Prestroke Modified Rankin Score 0-1
- ICA or M1 Occlusion on CT angiography or MR angiography
- ASPECTS 3-5 or DWI-ASPECTS 3-5
Show all 9Show fewer
- Randamization can be finished within 6 hours from last known well time, or 6 to 24 hours from last well known well time without positive lesion on MRI-FLAIR image.
- Endovascular treatment can be initiatedwithin 60 minutes from randomization
- Patient or Legally Authorized Representative has signed the Informed Consent form
Who cannot join
- Significant mass effect with midline shift
- Known allergy to contrast agents
- Evidence of acute intracranial hemorrhage
- Female who is pregnant or suspicision of pregnant
- Clinical evidence of chronic occlusion
- High risk of hemorrhage (platelet < 40,000 /µL, APTT > 50 second or PT-INR > 3.0)
- Participating in any other therapeutic investigational trial
- Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Endovascular Therapy for Acute Large Vessel Occlusion With Large Ischemic Core (RESCUE Japan LIMIT)
RESCUE-Japan LIMIT(Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism Japan Large IscheMIc core Trial) is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to compare the effectiveness of endovascular treatment as compared to best medical treatment alone in the acute ischemic stroke patients with an low ASPECTS (CT-ASPECTS 3-5 or DWI-ASPECTS 3-5).
The purpose of this study is to investigate the efficacy of endovascular treatment for acute large vessel occlusion with large ischemic core (CT-ASPECT score 3-5 or DWI-ASPECT score 3-5).
Read the detailed description
In the American Heart Association guideline 2018, endovascular therapy (EVT) has been strongly recommended as class of recommendation (COR) I for for the patients with acute cerebral large vessel occlusion (LVO), the Alberta Stroke Program Early CT Score (ASPECTS) 6 or more. The efficacy of EVT for the patients with low ASPECTS remains unclear.
This study is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to compare the effectiveness of endovascular treatment as compared to best medical treatment alone for acute large vessel occlusion patients with large ischemic core (ASPECTS 3-5 or DWI-ASPECTS 3-5).
Up to 200 subjects will be enrolled in the study and randomized for the Intention to treat analysis set. The randomization will be stratified by treatment institutes, patient's age (less than 75 years old or not), time from symptom onset (0-2 hours or more than 2 hours), and stroke severity (NIHSS 21 or more/less than 21), and administration of rt-PA.
Subjects who meet the inclusion criteria will be randomized in a 1:1 ratio to one of the following two treatment arms: Arm 1: best medical treatment Arm 2: best medical treatment plus endovascular treatment
Primary outcome of this study is to investigate efficacy of endivascular treatment in acute stroke patients with large ischemic core (ASPECTS 3-5 or DWI-ASPECTs 3-5) as compared to best medical treatment alone.
Approximately 40 sites in Japan Patients presenting with acute ischemic stroke (AIS) based on focal occlusion in the M1 segment of the middle cerebral artery (MCA), and/or the intracranial segment of the distal internal carotid artery (ICA), determined by Magnetic Resonance Angiography (MRA) or Computed Tomographic Angiography (CTA), and who meet all eligibility criteria will be considered for study enrollment.
- Conditions
- Mechanical Thrombectomy, Large Ischemic Core
- Being tested
- Endovascular treatment
- Keywords
- Acute cerebral infarction due to large vessel occlusion, Mechanical thrombectomy, Ischemic stroke
- 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
Acute thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| Best medical treatment | No intervention | Best medical treatment |
| Endovascular treatment | Experimental | Best medical treatment plus endovascular treatment Receives: Procedure: Endovascular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale ≤3 at 90 days
The primary endpoint of the trial is the modified Rankin Scale (mRS) ≤3 at 90 days post-stroke.The scale runs from 0-6 with 0 being perfect health without symptoms to 6 being death.
0: No symptoms.
- No significant disability. Able to carry out all usual activities, despite some symptoms.
- Slight disability. Able to look after own a符airs without assistance, but unable to carry out all previous activities.
- Moderate disability. Requires some help, but able to walk unassisted.
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- Severe disability. Requires constant nursing care and a悦ention, bedridden, incontinent.
- Dead.
Measured: 90 days
Secondary outcomes (9)
modified Rankin Scale≤2 at 90 days
Functional independence as difined by modified Rankin ScalemRS≤2 at 90 days
Measured: 90 days
modified Rankin Scale≤1 at 90 days
Excellent outcome as difined by modified Rankin Scale≤1 at 90 days
Measured: 90 days
Distribution of patients across the ordinal modified Rankin scale
The difference in linear trends in ordinal mRS outcomes between treatment groups (mRS shift analysis)
Measured: 90 days
NIHSS improvement 8 points or more at 48 hours
Early improvement of neulogical findings
Measured: 48 hours
Symptomatic intracranial hemorrhage within 48 hours
Defined as NIHSS worsening of 4 or more points associated with ICH within 48 hours of randomization
Measured: 48 hours
Intracranial hemorrhage within 48 hours
The incidence of hemorrhage
Measured: 48 hours
Death
Death due to any cause at 90 days
Measured: 90 days
Recurrence of cerebral infarction within 90 days
Recurrence of cerebral infarction
Measured: 90 days
Propotion of subjects who required decompressive craniectomy within 7 days
Propotion of subjects who had space-occupying infarction (malignant brain edema) and requred decompressive craniectomy within 7 days
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start30 Nov 2018
- Primary completion21 Dec 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mechanical ThrombectomyStudies 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
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyogo Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shinichi Yoshimura, Hyogo Medical University
- Investigators
- Shinichi Yoshimura, phD, Study chair, Hyogo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702413
- Sponsor's protocol ID
- R000038184
- Status last verified
- Jul 2022
- First submitted
- 4 Oct 2018
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tanaka K, Yoshimoto T, Koge J, Yamagami H, Imamura H, Sakai N, Uchida K, Beppu M, Matsumaru Y, Matsumoto Y, Kimura K, Ishikura R, Inoue M, Sakakibara F, Morimoto T, Yoshimura S, Toyoda K; RESCUE-Japan LIMIT Investigators. Detrimental Effect of Acute Hyperglycemia on the Outcomes of Large Ischemic Region Stroke. J Am Heart Assoc. 2024 Dec 3;13(23):e034556. doi: 10.1161/JAHA.124.034556. Epub 2024 Nov 22.
PubMed 39575760Inoue M, Yoshimoto T, Yamagami H, Toyoda K, Sakai N, Matsumaru Y, Matsumoto Y, Kimura K, Ishikura R, Uchida K, Beppu M, Sakakibara F, Morimoto T, Yoshimura S; RESCUE-Japan LIMIT Investigators. Expanding the Treatable Imaging Profile in Patients With Large Ischemic Stroke: Subanalysis From a Randomized Clinical Trial. Stroke. 2024 Jul;55(7):1730-1738. doi: 10.1161/STROKEAHA.124.046828. Epub 2024 May 28.
PubMed 38804134Shindo S, Uchida K, Yoshimura S, Sakai N, Yamagami H, Toyoda K, Matsumaru Y, Matsumoto Y, Kimura K, Ishikura R, Inoue M, Sakakibara F, Nakajima M, Ueda M, Morimoto T. Intravenous alteplase before endovascular therapy for acute large vessel occlusion with large ischemic core: subanalysis of a randomized clinical trial. J Neurointerv Surg. 2024 Oct 14;16(11):1094-1100. doi: 10.1136/jnis-2023-020846.
PubMed 37890987Ospel JM, Kunz WG, McDonough RV, Goyal M, Uchida K, Sakai N, Yamagami H, Yoshimura S; RESCUE-Japan LIMIT Investigators. Cost-effectiveness of Endovascular Treatment for Acute Stroke with Large Infarct: A United States Perspective. Radiology. 2023 Oct;309(1):e223320. doi: 10.1148/radiol.223320.
PubMed 37787675Namitome S, Uchida K, Shindo S, Yoshimura S, Sakai N, Yamagami H, Toyoda K, Matsumaru Y, Matsumoto Y, Kimura K, Ishikura R, Inoue M, Beppu M, Sakakibara F, Shirakawa M, Ueda M, Morimoto T; RESCUE-Japan LIMIT Investigators. Number of Passes of Endovascular Therapy for Stroke With a Large Ischemic Core: Secondary Analysis of RESCUE-Japan LIMIT. Stroke. 2023 Aug;54(8):1985-1992. doi: 10.1161/STROKEAHA.123.042552. Epub 2023 Jul 7.
PubMed 37417239Uchida K, Shindo S, Yoshimura S, Toyoda K, Sakai N, Yamagami H, Matsumaru Y, Matsumoto Y, Kimura K, Ishikura R, Yoshida A, Inoue M, Beppu M, Sakakibara F, Shirakawa M, Morimoto T; RESCUE-Japan LIMIT Investigators. Association Between Alberta Stroke Program Early Computed Tomography Score and Efficacy and Safety Outcomes With Endovascular Therapy in Patients With Stroke From Large-Vessel Occlusion: A Secondary Analysis of the Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism-Japan Large Ischemic Core Trial (RESCUE-Japan LIMIT). JAMA Neurol. 2022 Dec 1;79(12):1260-1266. doi: 10.1001/jamaneurol.2022.3285.
PubMed 36215044Yoshimura S, Sakai N, Yamagami H, Uchida K, Beppu M, Toyoda K, Matsumaru Y, Matsumoto Y, Kimura K, Takeuchi M, Yazawa Y, Kimura N, Shigeta K, Imamura H, Suzuki I, Enomoto Y, Tokunaga S, Morita K, Sakakibara F, Kinjo N, Saito T, Ishikura R, Inoue M, Morimoto T. Endovascular Therapy for Acute Stroke with a Large Ischemic Region. N Engl J Med. 2022 Apr 7;386(14):1303-1313. doi: 10.1056/NEJMoa2118191. Epub 2022 Feb 9.
PubMed 35138767
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Endovascular Therapy for Acute Large Vessel Occlusion With Large Ischemic Core (RESCUE Japan LIMIT)
- ClinicalTrials.gov ID
- NCT03702413
- Acronym / sponsor ID
- R000038184
- Conditions
- Mechanical Thrombectomy, Large Ischemic Core
- Keywords
- Acute cerebral infarction due to large vessel occlusion, Mechanical thrombectomy, Ischemic stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Hyogo Medical UniversityUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 11 Oct 2018 (actual)
- 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.
RESCUE-Japan LIMIT(Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism Japan Large IscheMIc core Trial) is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to compare the effectiveness of endovascular treatment as compared to best medical treatment alone in the acute ischemic stroke patients with an low ASPECTS (CT-ASPECTS 3-5 or DWI-ASPECTS 3-5).
The purpose of this study is to investigate the efficacy of endovascular treatment for acute large vessel occlusion with large ischemic core (CT-ASPECT score 3-5 or DWI-ASPECT score 3-5).
Detailed description
In the American Heart Association guideline 2018, endovascular therapy (EVT) has been strongly recommended as class of recommendation (COR) I for for the patients with acute cerebral large vessel occlusion (LVO), the Alberta Stroke Program Early CT Score (ASPECTS) 6 or more. The efficacy of EVT for the patients with low ASPECTS remains unclear.
This study is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to compare the effectiveness of endovascular treatment as compared to best medical treatment alone for acute large vessel occlusion patients with large ischemic core (ASPECTS 3-5 or DWI-ASPECTS 3-5).
Up to 200 subjects will be enrolled in the study and randomized for the Intention to treat analysis set. The randomization will be stratified by treatment institutes, patient's age (less than 75 years old or not), time from symptom onset (0-2 hours or more than 2 hours), and stroke severity (NIHSS 21 or more/less than 21), and administration of rt-PA.
Subjects who meet the inclusion criteria will be randomized in a 1:1 ratio to one of the following two treatment arms: Arm 1: best medical treatment Arm 2: best medical treatment plus endovascular treatment
Primary outcome of this study is to investigate efficacy of endivascular treatment in acute stroke patients with large ischemic core (ASPECTS 3-5 or DWI-ASPECTs 3-5) as compared to best medical treatment alone.
Approximately 40 sites in Japan Patients presenting with acute ischemic stroke (AIS) based on focal occlusion in the M1 segment of the middle cerebral artery (MCA), and/or the intracranial segment of the distal internal carotid artery (ICA), determined by Magnetic Resonance Angiography (MRA) or Computed Tomographic Angiography (CTA), and who meet all eligibility criteria will be considered for study enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best medical treatment | No intervention | –Best medical treatment |
| Endovascular treatment | Experimental | Procedure: Endovascular treatmentBest medical treatment plus endovascular treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Acute cerebral infarction
- Age ≥ 18
- NIHSS ≥ 6
- Prestroke Modified Rankin Score 0-1
- ICA or M1 Occlusion on CT angiography or MR angiography
Key exclusion criteria (8 listed)
- Significant mass effect with midline shift
- Known allergy to contrast agents
- Evidence of acute intracranial hemorrhage
- Female who is pregnant or suspicision of pregnant
- Clinical evidence of chronic occlusion
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 treatmentAcute thrombectomy | Procedure or surgery | Endovascular treatment |
Primary outcome
modified Rankin Scale ≤3 at 90 days
Time frame: 90 days
The primary endpoint of the trial is the modified Rankin Scale (mRS) ≤3 at 90 days post-stroke.The scale runs from 0-6 with 0 being perfect health without symptoms to 6 being death. 0: No symptoms. 1. No significant disability. Able to carry out all usual activities, despite some symptoms. 2. Slight disability. Able to look after own a符airs without assistance, but unable to carry out all previous activities. 3. Moderate disability. Requires some help, but able to walk unassisted. 4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. Severe disability. Requires constant nursing care and a悦ention, bedridden, incontinent. 6. Dead.
9 secondary outcomes
modified Rankin Scale≤2 at 90 days
Time frame: 90 days
modified Rankin Scale≤1 at 90 days
Time frame: 90 days
Distribution of patients across the ordinal modified Rankin scale
Time frame: 90 days
NIHSS improvement 8 points or more at 48 hours
Time frame: 48 hours
Symptomatic intracranial hemorrhage within 48 hours
Time frame: 48 hours
Intracranial hemorrhage within 48 hours
Time frame: 48 hours
Death
Time frame: 90 days
Recurrence of cerebral infarction within 90 days
Time frame: 90 days
Propotion of subjects who required decompressive craniectomy within 7 days
Time frame: 7 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 12 Jul 2022.
- Derived from this study: PubMed 39575760Tanaka K, Yoshimoto T, Koge J, Yamagami H, Imamura H, Sakai N, Uchida K, Beppu M, Matsumaru Y, Matsumoto Y, Kimura K, Ishikura R, Inoue M, Sakakibara F, Morimoto T, Yoshimura S, Toyoda K; RESCUE-Japan LIMIT Investigators. Detrimental Effect of Acute Hyperglycemia on the Outcomes of Large Ischemic Region Stroke. J Am Heart Assoc. 2024 Dec 3;13(23):e034556. doi: 10.1161/JAHA.124.034556. Epub 2024 Nov 22.
- Derived from this study: PubMed 38804134Inoue M, Yoshimoto T, Yamagami H, Toyoda K, Sakai N, Matsumaru Y, Matsumoto Y, Kimura K, Ishikura R, Uchida K, Beppu M, Sakakibara F, Morimoto T, Yoshimura S; RESCUE-Japan LIMIT Investigators. Expanding the Treatable Imaging Profile in Patients With Large Ischemic Stroke: Subanalysis From a Randomized Clinical Trial. Stroke. 2024 Jul;55(7):1730-1738. doi: 10.1161/STROKEAHA.124.046828. Epub 2024 May 28.
- Derived from this study: PubMed 37890987Shindo S, Uchida K, Yoshimura S, Sakai N, Yamagami H, Toyoda K, Matsumaru Y, Matsumoto Y, Kimura K, Ishikura R, Inoue M, Sakakibara F, Nakajima M, Ueda M, Morimoto T. Intravenous alteplase before endovascular therapy for acute large vessel occlusion with large ischemic core: subanalysis of a randomized clinical trial. J Neurointerv Surg. 2024 Oct 14;16(11):1094-1100. doi: 10.1136/jnis-2023-020846.
- Derived from this study: PubMed 37787675Ospel JM, Kunz WG, McDonough RV, Goyal M, Uchida K, Sakai N, Yamagami H, Yoshimura S; RESCUE-Japan LIMIT Investigators. Cost-effectiveness of Endovascular Treatment for Acute Stroke with Large Infarct: A United States Perspective. Radiology. 2023 Oct;309(1):e223320. doi: 10.1148/radiol.223320.
- Derived from this study: PubMed 37417239Namitome S, Uchida K, Shindo S, Yoshimura S, Sakai N, Yamagami H, Toyoda K, Matsumaru Y, Matsumoto Y, Kimura K, Ishikura R, Inoue M, Beppu M, Sakakibara F, Shirakawa M, Ueda M, Morimoto T; RESCUE-Japan LIMIT Investigators. Number of Passes of Endovascular Therapy for Stroke With a Large Ischemic Core: Secondary Analysis of RESCUE-Japan LIMIT. Stroke. 2023 Aug;54(8):1985-1992. doi: 10.1161/STROKEAHA.123.042552. Epub 2023 Jul 7.
- Derived from this study: PubMed 36215044Uchida K, Shindo S, Yoshimura S, Toyoda K, Sakai N, Yamagami H, Matsumaru Y, Matsumoto Y, Kimura K, Ishikura R, Yoshida A, Inoue M, Beppu M, Sakakibara F, Shirakawa M, Morimoto T; RESCUE-Japan LIMIT Investigators. Association Between Alberta Stroke Program Early Computed Tomography Score and Efficacy and Safety Outcomes With Endovascular Therapy in Patients With Stroke From Large-Vessel Occlusion: A Secondary Analysis of the Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism-Japan Large Ischemic Core Trial (RESCUE-Japan LIMIT). JAMA Neurol. 2022 Dec 1;79(12):1260-1266. doi: 10.1001/jamaneurol.2022.3285.
- Derived from this study: PubMed 35138767Yoshimura S, Sakai N, Yamagami H, Uchida K, Beppu M, Toyoda K, Matsumaru Y, Matsumoto Y, Kimura K, Takeuchi M, Yazawa Y, Kimura N, Shigeta K, Imamura H, Suzuki I, Enomoto Y, Tokunaga S, Morita K, Sakakibara F, Kinjo N, Saito T, Ishikura R, Inoue M, Morimoto T. Endovascular Therapy for Acute Stroke with a Large Ischemic Region. N Engl J Med. 2022 Apr 7;386(14):1303-1313. doi: 10.1056/NEJMoa2118191. Epub 2022 Feb 9.
- Individual participant dataSharing planned: No
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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, phD study chair
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 Endovascular treatment in people with Mechanical Thrombectomy and Large Ischemic Core, 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 9 inclusion and 8 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 12 Jul 2022. 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 ≤3 at 90 days (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 NCT03702413, which also lists 7 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 12 Jul 2022.