StrokeVSUNCT07635498
Virtual Stroke Units Versus Conventional Stroke Unit Care in Non-Thrombectomy-Candidate Patients.
An observational study of Stroke and Stroke Hemorrhagic, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
Trial summary
Stroke is the leading cause of acquired disability in adults and a major cause of mortality worldwide; in Spain, Andalusia shows the highest stroke-related mortality rate. Comprehensive Stroke Units (SU) are the gold-standard organizational model for acute stroke care; however, only a fraction of patients have direct… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke Hemorrhagic, Ischemic Stroke
- What is being tested?
- (Healthcare organizational model) and Conventional care
- Type of treatment
- Injection or infusion
- How many people
- 726 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2026to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with acute stroke (ischemic or hemorrhagic) not eligible for mechanical thrombectomy
Who may be able to join
- Age ≥ 18 years.
- Diagnosis of acute stroke (ischemic or hemorrhagic) confirmed by clinical assessment and neuroimaging (CT and/or MRI) within 24 hours of symptom onset or last-seen-well.
- Not a candidate for mechanical thrombectomy according to current clinical guidelines.
- Admission to a participating hospital (Hospital de Riotinto, Hospital San Juan de Dios del Aljarafe, or Hospital Universitario Virgen Macarena).
- Signed informed consent by the participant or legal representative. Exclusion Criteria
- Pre-stroke modified Rankin Scale (mRS) ≥ 4.
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- Life expectancy < 6 months due to non-stroke comorbid conditions.
- Inability to complete protocolized follow-up (geographical, social, or clinical reasons).
- Concurrent participation in another interventional clinical trial that may affect study endpoints.
- Refusal to provide informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital San Juan de Dios, Bormujos
Seville
Barragán, PhD, MD, +34628551316, ana.barragan.prieto.sspa@juntadeandalucia.es
About this study
Official title: Virtual Stroke Units Versus Conventional Stroke Unit Care in Non-Thrombectomy-Candidate Patients: A Non-Inferiority Prospective Cohort Study
Stroke is the leading cause of acquired disability in adults and a major cause of mortality worldwide; in Spain, Andalusia shows the highest stroke-related mortality rate. Comprehensive Stroke Units (SU) are the gold-standard organizational model for acute stroke care; however, only a fraction of patients have direct access to an SU, particularly those not eligible for mechanical thrombectomy who are admitted to regional or district hospitals without on-site SU capacity.
The Virtual Stroke Unit (VSU) concept extends specialized stroke care to non-SU hospitals by combining standardized in-hospital monitoring boxes with synchronous remote multidisciplinary assessment by a stroke neurologist and stroke nurse from a reference center, via the regional telemedicine platform (CATI).
This prospective, multicenter, non-inferiority cohort study compares effectiveness, safety, and feasibility of VSU care versus conventional SU care in patients with acute ischemic or hemorrhagic stroke who are not candidates for mechanical thrombectomy. Recruitment targets 363 patients per arm (726 total). The primary outcome is death or dependency at 3 months (modified Rankin Scale 3-6) - the canonical measure of stroke-unit effectiveness - with functional independence (mRS 0-2), adherence to the stroke-unit care quality bundle, safety, mortality, recurrence, length of stay, satisfaction (TUQ/TSQ/TMPQ) and cost-effectiveness as secondary outcomes.
Read the detailed description
Background. Stroke Units reduce mortality and dependence in acute stroke patients regardless of stroke subtype, severity, age or sex. However, in Andalusia, only a small proportion of acute stroke patients are admitted to an SU; many patients who are not candidates for mechanical thrombectomy remain hospitalized in non-SU wards of regional hospitals, with limited access to structured stroke-specific multidisciplinary care.
Rationale. Telemedicine-supported organizational models have shown promise to bridge the access gap for time-sensitive stroke care. The Virtual Stroke Unit (VSU) is a novel organizational model that combines (i) standardized monitoring boxes in non-SU hospitals with predefined nursing protocols, (ii) a daily synchronous joint visit between the local team and the reference SU team via the CATI telemedicine platform, and (iii) structured remote follow-up and discharge planning. The VSU model has not been formally evaluated in a comparative prospective study.
Objectives. Primary: to test whether VSU care is non-inferior to conventional SU care for 3-month functional outcome (mRS) in patients with acute stroke not eligible for mechanical thrombectomy. Secondary: to evaluate safety (in-hospital complications, mortality), efficiency (length of stay, inter-hospital transfers), patient and provider satisfaction (TUQ/TSQ/TMPQ), 1-year functional outcome and recurrence, and cost-effectiveness.
Design. Prospective multicenter cohort study with two parallel groups:
- VSU group: consecutive eligible patients admitted to Hospital de Riotinto (Huelva) or Hospital San Juan de Dios del Aljarafe (Bormujos), receiving structured remote care from the CATI/Virgen Macarena stroke team.
- Conventional SU group (control): consecutive eligible patients admitted to the Stroke Unit of Hospital Universitario Virgen Macarena (Sevilla), without telemedicine support.
Sample size. 363 patients per group (726 total) to detect non-inferiority of VSU vs SU on the primary outcome, with a non-inferiority margin of 10%, 80% power, two-sided α = 5%, and an estimated 15% loss to follow-up.
- Conditions
- Stroke, Stroke Hemorrhagic, Ischemic Stroke
- Being tested
- (Healthcare organizational model), Conventional care
- Keywords
- Virtual Stroke Unit, Telemedicine, Telestroke, Stroke Unit, Healthcare delivery system, Non-inferiority, Modified Rankin Scale
- Medical subject headings
- Stroke, Hemorrhagic Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Healthcare organizational model)Other
Structured multidisciplinary stroke care delivered remotely from the reference Stroke Unit (Hospital Universitario Virgen Macarena) to non-SU hospitals (Hospital de Riotinto, Hospital San Juan de Dios del Aljarafe). Components: (i) standardized stroke monitoring boxes with predefined nursing protocols; (ii) synchronous joint assessment between local team and reference stroke neurologist/nurse via CATI videoconferencing on day 1 of admission; (iii) structured remote follow-up during hospitalization; (iv) standardized teleconsultation discharge report; (v) protocolized scheduled remote re-assessment at 1 week, 1 month, 3 months and 12 months.
Conventional careOther
Bundle of conventional stroke unit care
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Virtual Stroke Unit (VSU) | Patients with acute stroke (ischemic or hemorrhagic) not eligible for mechanical thrombectomy, admitted consecutively to Hospital de Riotinto (Huelva) or Hospital San Juan de Dios del Aljarafe (Bormujos, Sevilla). Care is delivered in standardized monitoring boxes following an SU-equivalent nursing protocol, with daily synchronous joint assessment by the reference stroke team (Hospital Universitario Virgen Macarena) via the CATI telemedicine platform. Receives: Other: (Healthcare organizational model) | |
| Group 2 - Conventional Stroke Unit (Control) | Patients with acute stroke (ischemic or hemorrhagic) not eligible for mechanical thrombectomy, admitted consecutively to the Stroke Unit of Hospital Universitario Virgen Macarena (Sevilla). Care is delivered in person by the local SU multidisciplinary team without telemedicine support. Receives: Other: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or dependency at 90 days (modified Rankin Scale 3-6)
Proportion of participants who are dead or functionally dependent (mRS 3-6) at 90 ± 15 days post-admission. The mRS is a 7-level clinician-rated scale (0 = no symptoms; 6 = death); the 3-6 range is the canonical measure of stroke-unit effectiveness (avoidance of death or dependency). Non-inferiority of VSU versus conventional SU care is declared if the upper limit of the one-sided 95% confidence interval for the between-group difference does not exceed the pre-specified +10 percentage-point margin.
Measured: 90 days from index admission
Secondary outcomes (5)
Adherence to the stroke-unit care quality bundle
Proportion of participants receiving a predefined stroke-unit care bundle during the index admission, equivalent to conventional SU standards: dysphagia screening before oral intake, early mobilization, neurological/vital-sign monitoring protocol, antithrombotic therapy within 48 h when indicated, and structured multidisciplinary assessment. Measures whether VSU care reproduces the quality of conventional stroke-unit care.
Measured: Index admission
In-hospital complications (composite safety endpoint)
Composite of in-hospital medical complications: symptomatic intracranial hemorrhage, early neurological worsening (NIHSS ≥ 4 points), aspiration pneumonia, deep vein thrombosis, urinary tract infection, in-hospital death.
Measured: Index admission (median 7-10 days)
Etiological classification (TOAST)
Distribution of TOAST etiological categories in ischemic strokes (large-artery atherosclerosis, cardioembolic, small-vessel, other determined, undetermined).
Measured: 3 months
Adherence to secondary prevention
Proportion of participants on guideline-concordant secondary prevention (antithrombotic therapy, antihypertensives, statins, anticoagulation if indicated) at 3 and 12 months.
Measured: 3 and 12 months
Length of hospital stay
Length of index admission in days, from admission to discharge
Measured: Index admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Apr 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- 726 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen Macarena
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635498
- Sponsor's protocol ID
- PI24/01807
- Acronym
- VSU
- Status last verified
- May 2026
- First submitted
- 3 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing of individual participant data (IPD) is not currently planned. Aggregated study results will be disseminated through peer-reviewed publications and scientific congresses. Requests for de-identified IPD may be considered on a case-by-case basis subject to data protection regulations (GDPR), ethical approval and a formal data-sharing agreement.
Publications
Behrens JR, Kaffes M, Aigner A, Herm J, Erdur H, Siepmann T, Barlinn J, Hubert G, Wiestler H, Gumbinger C, Ranta A, von Weitzel-Mudersbach P, Rocco A, Hofmann-Shen C, Muhn F, Liman T, Rozanski M, Litmeier S, Riegler C, Hellwig S, Geran R, Koschutzke L, Ditsche H, Kotlarz-Bottcher M, Kinze S, Audebert H. Teleneurology vs On-Site Neurology Consultation for Postadmission Hospital Care of Stroke. JAMA Neurol. 2026 Apr 6;83(6):554-62. doi: 10.1001/jamaneurol.2026.0615. Online ahead of print.
PubMed 41941227Martins SO, Feigin V, Carbonera LA, de Souza AC, Secchi TL, Nair B, Sposato LA, Liu L, Molina CA, Nogueira RG. Integrating Digital Health Into Stroke Policies. Stroke. 2026 Jun;57(6):1796-1809. doi: 10.1161/STROKEAHA.125.050451. Epub 2026 Mar 30.
PubMed 41906872Barragan-Prieto A, Perez-Sanchez S, Moniche F, Moyano RV, Delgado F, Martinez-Sanchez P, Moya M, Oropesa JM, Minguez-Castellanos A, Villegas I, Alvarez Soria MJ, Tamayo Toledo JA, de la Cruz Cosme C, Canto Neguillo R, Herrerias Esteban JM, Montero Cobos DJ, Moreno Munoz JA, Gonzalez A, Montaner J. Express improvement of acute stroke care accessibility in large regions using a centralized telestroke network. Eur Stroke J. 2022 Sep;7(3):259-266. doi: 10.1177/23969873221101282. Epub 2022 May 25.
PubMed 36082245
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Stroke Units Versus Conventional Stroke Unit Care in Non-Thrombectomy-Candidate Patients: A Non-Inferiority Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07635498
- Acronym / sponsor ID
- VSU / PI24/01807
- Conditions
- Stroke, Stroke Hemorrhagic, Ischemic Stroke
- Keywords
- Virtual Stroke Unit, Telemedicine, Telestroke, Stroke Unit, Healthcare delivery system, Non-inferiority, Modified Rankin Scale
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 726 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen MacarenaUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 9 Jun 2026 (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.
Stroke is the leading cause of acquired disability in adults and a major cause of mortality worldwide; in Spain, Andalusia shows the highest stroke-related mortality rate. Comprehensive Stroke Units (SU) are the gold-standard organizational model for acute stroke care; however, only a fraction of patients have direct access to an SU, particularly those not eligible for mechanical thrombectomy who are admitted to regional or district hospitals without on-site SU capacity.
The Virtual Stroke Unit (VSU) concept extends specialized stroke care to non-SU hospitals by combining standardized in-hospital monitoring boxes with synchronous remote multidisciplinary assessment by a stroke neurologist and stroke nurse from a reference center, via the regional telemedicine platform (CATI).
This prospective, multicenter, non-inferiority cohort study compares effectiveness, safety, and feasibility of VSU care versus conventional SU care in patients with acute ischemic or hemorrhagic stroke who are not candidates for mechanical thrombectomy. Recruitment targets 363 patients per arm (726 total). The primary outcome is death or dependency at 3 months (modified Rankin Scale 3-6) - the canonical measure of stroke-unit effectiveness - with functional independence (mRS 0-2), adherence to the stroke-unit care quality bundle, safety, mortality, recurrence, length of stay, satisfaction (TUQ/TSQ/TMPQ) and cost-effectiveness as secondary outcomes.
Detailed description
Background. Stroke Units reduce mortality and dependence in acute stroke patients regardless of stroke subtype, severity, age or sex. However, in Andalusia, only a small proportion of acute stroke patients are admitted to an SU; many patients who are not candidates for mechanical thrombectomy remain hospitalized in non-SU wards of regional hospitals, with limited access to structured stroke-specific multidisciplinary care.
Rationale. Telemedicine-supported organizational models have shown promise to bridge the access gap for time-sensitive stroke care. The Virtual Stroke Unit (VSU) is a novel organizational model that combines (i) standardized monitoring boxes in non-SU hospitals with predefined nursing protocols, (ii) a daily synchronous joint visit between the local team and the reference SU team via the CATI telemedicine platform, and (iii) structured remote follow-up and discharge planning. The VSU model has not been formally evaluated in a comparative prospective study.
Objectives. Primary: to test whether VSU care is non-inferior to conventional SU care for 3-month functional outcome (mRS) in patients with acute stroke not eligible for mechanical thrombectomy. Secondary: to evaluate safety (in-hospital complications, mortality), efficiency (length of stay, inter-hospital transfers), patient and provider satisfaction (TUQ/TSQ/TMPQ), 1-year functional outcome and recurrence, and cost-effectiveness.
Design. Prospective multicenter cohort study with two parallel groups:
- VSU group: consecutive eligible patients admitted to Hospital de Riotinto (Huelva) or Hospital San Juan de Dios del Aljarafe (Bormujos), receiving structured remote care from the CATI/Virgen Macarena stroke team.
- Conventional SU group (control): consecutive eligible patients admitted to the Stroke Unit of Hospital Universitario Virgen Macarena (Sevilla), without telemedicine support.
Sample size. 363 patients per group (726 total) to detect non-inferiority of VSU vs SU on the primary outcome, with a non-inferiority margin of 10%, 80% power, two-sided α = 5%, and an estimated 15% loss to follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Virtual Stroke Unit (VSU) | – | Other: (Healthcare organizational model)Patients with acute stroke (ischemic or hemorrhagic) not eligible for mechanical thrombectomy, admitted consecutively to Hospital de Riotinto (Huelva) or Hospital San Juan de Dios del Aljarafe (Bormujos, Sevilla). Care is delivered in standardized monitoring boxes following an SU-equivalent nursing protocol, with daily synchronous joint assessment by the reference stroke team (Hospital Universitario Virgen Macarena) via the CATI telemedicine platform. |
| Group 2 - Conventional Stroke Unit (Control) | – | Other: Conventional carePatients with acute stroke (ischemic or hemorrhagic) not eligible for mechanical thrombectomy, admitted consecutively to the Stroke Unit of Hospital Universitario Virgen Macarena (Sevilla). Care is delivered in person by the local SU multidisciplinary team without telemedicine support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute stroke (ischemic or hemorrhagic) not eligible for mechanical thrombectomy
Key inclusion criteria (10 listed)
- Age ≥ 18 years.
- Diagnosis of acute stroke (ischemic or hemorrhagic) confirmed by clinical assessment and neuroimaging (CT and/or MRI) within 24 hours of symptom onset or last-seen-well.
- Not a candidate for mechanical thrombectomy according to current clinical guidelines.
- Admission to a participating hospital (Hospital de Riotinto, Hospital San Juan de Dios del Aljarafe, or Hospital Universitario Virgen Macarena).
- Signed informed consent by the participant or legal representative. Exclusion Criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| (Healthcare organizational model)Structured multidisciplinary stroke care delivered remotely from the reference Stroke Unit (Hospital Universitario Virgen Macarena) to non-SU hospitals (Hospital de Riotinto, Hospital San Juan de Dios del Aljarafe). Components: (i) standardized stroke monitoring boxes with predefined nursing protocols; (ii) synchronous joint assessment between local team and reference stroke neurologist/nurse via CATI videoconferencing on day 1 of admission; (iii) structured remote follow-up during hospitalization; (iv) standardized teleconsultation discharge report; (v) protocolized scheduled remote re-assessment at 1 week, 1 month, 3 months and 12 months. | Other | Group 1 - Virtual Stroke Unit (VSU) |
| Conventional careBundle of conventional stroke unit care | Other | Group 2 - Conventional Stroke Unit (Control) |
Primary outcome
Death or dependency at 90 days (modified Rankin Scale 3-6)
Time frame: 90 days from index admission
Proportion of participants who are dead or functionally dependent (mRS 3-6) at 90 ± 15 days post-admission. The mRS is a 7-level clinician-rated scale (0 = no symptoms; 6 = death); the 3-6 range is the canonical measure of stroke-unit effectiveness (avoidance of death or dependency). Non-inferiority of VSU versus conventional SU care is declared if the upper limit of the one-sided 95% confidence interval for the between-group difference does not exceed the pre-specified +10 percentage-point margin.
5 secondary outcomes
Adherence to the stroke-unit care quality bundle
Time frame: Index admission
In-hospital complications (composite safety endpoint)
Time frame: Index admission (median 7-10 days)
Etiological classification (TOAST)
Time frame: 3 months
Adherence to secondary prevention
Time frame: 3 and 12 months
Length of hospital stay
Time frame: Index admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Background: PubMed 41941227Behrens JR, Kaffes M, Aigner A, Herm J, Erdur H, Siepmann T, Barlinn J, Hubert G, Wiestler H, Gumbinger C, Ranta A, von Weitzel-Mudersbach P, Rocco A, Hofmann-Shen C, Muhn F, Liman T, Rozanski M, Litmeier S, Riegler C, Hellwig S, Geran R, Koschutzke L, Ditsche H, Kotlarz-Bottcher M, Kinze S, Audebert H. Teleneurology vs On-Site Neurology Consultation for Postadmission Hospital Care of Stroke. JAMA Neurol. 2026 Apr 6;83(6):554-62. doi: 10.1001/jamaneurol.2026.0615. Online ahead of print.
- Background: PubMed 41906872Martins SO, Feigin V, Carbonera LA, de Souza AC, Secchi TL, Nair B, Sposato LA, Liu L, Molina CA, Nogueira RG. Integrating Digital Health Into Stroke Policies. Stroke. 2026 Jun;57(6):1796-1809. doi: 10.1161/STROKEAHA.125.050451. Epub 2026 Mar 30.
- Background: PubMed 36082245Barragan-Prieto A, Perez-Sanchez S, Moniche F, Moyano RV, Delgado F, Martinez-Sanchez P, Moya M, Oropesa JM, Minguez-Castellanos A, Villegas I, Alvarez Soria MJ, Tamayo Toledo JA, de la Cruz Cosme C, Canto Neguillo R, Herrerias Esteban JM, Montero Cobos DJ, Moreno Munoz JA, Gonzalez A, Montaner J. Express improvement of acute stroke care accessibility in large regions using a centralized telestroke network. Eur Stroke J. 2022 Sep;7(3):259-266. doi: 10.1177/23969873221101282. Epub 2022 May 25.
- Individual participant dataSharing planned: Undecided. Sharing of individual participant data (IPD) is not currently planned. Aggregated study results will be disseminated through peer-reviewed publications and scientific congresses. Requests for de-identified IPD may be considered on a case-by-case basis subject to data protection regulations (GDPR), ethical approval and a formal data-sharing agreement.
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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.
Hospital San Juan de Dios, Bormujos
Seville, Spain
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 Stroke and Stroke Hemorrhagic, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
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 10 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or dependency at 90 days (modified Rankin Scale 3-6) (time frame: 90 days from index admission). 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 NCT07635498, which also lists 3 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 18 Jun 2026.