Acute Ischemic StrokeK-NETNCT05213533
Kanagawa Intravenous and Endvascular Treatment Registry
An observational study of Acute Ischemic Stroke, run by St. Marianna University Toyoko Hospital at 1 site in Japan.
Trial summary
The K-NET registry is a prospective, multicenter, observational registry study for all consecutive patients who received intravenous tPA therapy and/or endovascular treatment for acute ischemic stroke. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 4,000 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jan 2018to Oct 2022
- How long will I take part?
- 4 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Residents of Kanagawa prefecture in Japan
Who may be able to join
- Inclusion criteria for this study are all consecutive patients who meet either or both of the patients who received intravenous tPA therapy for acute ischemic stroke and intention to perform EVT for large vessel occlusion.
Who cannot join
- There were no exclusion criteria. There are no upper or lower age limits for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kanagawa Intravenous and Endovascular Treatment Registry for Acute Ischemic Stroke
The K-NET registry is a prospective, multicenter, observational registry study for all consecutive patients who received intravenous tPA therapy and/or endovascular treatment for acute ischemic stroke. This study is attended by 40 of the 58 Primary Stroke Centers in Kanagawa Prefecture, which is located in the Tokyo metropolitan area and has a population of 9.24 million. Patient enrollment for this study began in January 2018.
Read the detailed description
Inclusion criteria for this study are all consecutive patients who meet either or both of the patients who received intravenous tPA therapy for acute ischemic stroke and intention to perform EVT for large vessel occlusion. There were no exclusion criteria. The local neurologists, neurosurgeons, and neurointerventionalists at each institution made the decision to perform EVT and intravenous tPA.
The primary outcome was good as defined by the modified Rankin Scale (mRS) of 0 to 2 at three months. We also determined a favorable outcome: mRS 0-2 or not worsening of the mRS score at three months. Secondary analyses included predicting a favorable outcome using multivariate logistic regression analysis.
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute stroke, mechanical thrombectomy, intravenous tPA
- Medical subject headings
- Ischemic Stroke, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale
The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 6. This is the most widely used outcome measure in stroke clinical trials. Standardized interviews to obtain a mRS score are recommended at 3 months following hospital discharge.
0 The patient has no residual symptoms.
- The patient has no significant disability; able to carry out all pre-stroke activities.
- The patient has slight disability; unable to carry out all pre-stroke activities but able to look after self without daily help.
- The patient has moderate disability; requiring some external help but able to walk without the assistance of another individual.
- The patient has moderately severe disability; unable to walk or attend to bodily functions without assistance of another individual.
- The patient has severe disability; bedridden, incontinent, requires continuous care.
- The patient has expired.
Measured: after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Jan 2018
- Primary completionApr 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- 4,000 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- St. Marianna University Toyoko Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toshihiro Ueda, MD, St. Marianna University Toyoko Hospital
- Investigators
- Toshihiro Ueda, MD, Principal investigator, St. Marianna University Toyoko Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213533
- Sponsor's protocol ID
- 3757
- Acronym
- K-NET
- Status last verified
- Jan 2022
- First submitted
- 16 Jan 2022
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Usuki N, Ueda T, Takeuchi M, Morimoto M, Tsuboi Y, Yamamoto R, Takaishi S, Tatsuno K, Ito H, Shimizu T, Yamano Y; K-NET Registry Investigators. Recent outcomes of intravenous tissue plasminogen activator (t-PA) alone in the era of mechanical thrombectomy: A sub-analysis of the Kanagawa Intravenous and Endovascular Treatment (K-NET) registry. Clin Neurol Neurosurg. 2026 Mar;262:109316. doi: 10.1016/j.clineuro.2026.109316. Epub 2026 Jan 7.
PubMed 41518935Ueda T, Hasegawa Y, Takeuchi M, Morimoto M, Yamamoto R, Tsuboi Y, Kaga Y, Ito H, Onodera H, Takaishi S, Tatsuno K, Usuki N, Yoshie T, Murata H, Yamano Y; K-NET Registry Investigators. Comparative analysis of outcome-associated factors following endovascular treatment for intracranial atherosclerotic disease and cardioembolism: A subanalysis of the K-NET registry. Interv Neuroradiol. 2025 Aug 1:15910199251361304. doi: 10.1177/15910199251361304. Online ahead of print.
PubMed 40746094
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kanagawa Intravenous and Endovascular Treatment Registry for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05213533
- Acronym / sponsor ID
- K-NET / 3757
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute stroke, mechanical thrombectomy, intravenous tPA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- St. Marianna University Toyoko HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 28 Jan 2022 (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.
The K-NET registry is a prospective, multicenter, observational registry study for all consecutive patients who received intravenous tPA therapy and/or endovascular treatment for acute ischemic stroke. This study is attended by 40 of the 58 Primary Stroke Centers in Kanagawa Prefecture, which is located in the Tokyo metropolitan area and has a population of 9.24 million. Patient enrollment for this study began in January 2018.
Detailed description
Inclusion criteria for this study are all consecutive patients who meet either or both of the patients who received intravenous tPA therapy for acute ischemic stroke and intention to perform EVT for large vessel occlusion. There were no exclusion criteria. The local neurologists, neurosurgeons, and neurointerventionalists at each institution made the decision to perform EVT and intravenous tPA.
The primary outcome was good as defined by the modified Rankin Scale (mRS) of 0 to 2 at three months. We also determined a favorable outcome: mRS 0-2 or not worsening of the mRS score at three months. Secondary analyses included predicting a favorable outcome using multivariate logistic regression analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents of Kanagawa prefecture in Japan
Key inclusion criteria (1 listed)
- Inclusion criteria for this study are all consecutive patients who meet either or both of the patients who received intravenous tPA therapy for acute ischemic stroke and intention to perform EVT for large vessel occlusion.
Key exclusion criteria (1 listed)
- There were no exclusion criteria. There are no upper or lower age limits for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
modified Rankin Scale
Time frame: after 3 months
The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 6. This is the most widely used outcome measure in stroke clinical trials. Standardized interviews to obtain a mRS score are recommended at 3 months following hospital discharge. 0 The patient has no residual symptoms. 1. The patient has no significant disability; able to carry out all pre-stroke activities. 2. The patient has slight disability; unable to carry out all pre-stroke activities but able to look after self without daily help. 3. The patient has moderate disability; requiring some external help but able to walk without the assistance of another individual. 4. The patient has moderately severe disability; unable to walk or attend to bodily functions without assistance of another individual. 5. The patient has severe disability; bedridden, incontinent, requires continuous care. 6. The patient has expired.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Derived from this study: PubMed 41518935Usuki N, Ueda T, Takeuchi M, Morimoto M, Tsuboi Y, Yamamoto R, Takaishi S, Tatsuno K, Ito H, Shimizu T, Yamano Y; K-NET Registry Investigators. Recent outcomes of intravenous tissue plasminogen activator (t-PA) alone in the era of mechanical thrombectomy: A sub-analysis of the Kanagawa Intravenous and Endovascular Treatment (K-NET) registry. Clin Neurol Neurosurg. 2026 Mar;262:109316. doi: 10.1016/j.clineuro.2026.109316. Epub 2026 Jan 7.
- Derived from this study: PubMed 40746094Ueda T, Hasegawa Y, Takeuchi M, Morimoto M, Yamamoto R, Tsuboi Y, Kaga Y, Ito H, Onodera H, Takaishi S, Tatsuno K, Usuki N, Yoshie T, Murata H, Yamano Y; K-NET Registry Investigators. Comparative analysis of outcome-associated factors following endovascular treatment for intracranial atherosclerotic disease and cardioembolism: A subanalysis of the K-NET registry. Interv Neuroradiol. 2025 Aug 1:15910199251361304. doi: 10.1177/15910199251361304. Online ahead of print.
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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.
Toshihiro Ueda, MD principal investigator
St. Marianna University Toyoko Hospital
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 Acute Ischemic Stroke, run by St. Marianna University Toyoko Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 11 Feb 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?
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?
modified Rankin Scale (time frame: after 3 months). 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 NCT05213533, which also lists 2 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 11 Feb 2022.