Medium Vessel Occlusion Stroke (MeVO)SAIL MEVONCT07843797
SAIL-MEVO: Endovascular Treatment Versus Best Medical Therapy for Distal Vessel Occlusions
A study testing best medical therapy and Endovascular Treatment in people with Medium Vessel Occlusion Stroke (MeVO) and Stroke Acute, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Patients with acute ischemic stroke caused by distal or medium vessel occlusions (MeVOs) may experience significant disability despite receiving the current standard medical treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Medium Vessel Occlusion Stroke (MeVO), Stroke Acute, Acute Ischemic Stroke
- What is being tested?
- best medical therapy and Endovascular Treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2026to Jul 2029
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years.
- Pre-stroke modified Rankin Scale (mRS) score of 0-1.
- Baseline NIH Stroke Scale (NIHSS) score between 9 and 17.
- Symptom onset to randomization less than 12 hours.
- Acute ischemic stroke due to an isolated medium/distal vessel occlusion involving a non-dominant M2-M3 middle cerebral artery, A2-A3 anterior cerebral artery, or P2-P3 posterior cerebral artery confirmed by CTA or MRA.
- Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on non-contrast CT AND AI-predicted infarct core volume <10 mL on non-contrast CT (when available) AND AI-defined Tmax >6s volumen >30cc on CTP (when available).
- Written informed consent obtained from the participant or a legally authorized representative in accordance with local regulations.
Who cannot join
- Proximal large vessel occlusion (internal carotid artery or M1 segment) or tandem cervical internal carotid artery stenosis >70%.
- Intracranial hemorrhage at baseline imaging.
- Pregnancy.
- Life expectancy less than 3 months.
- Severe allergy to iodinated contrast media.
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 Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
MARC RIBO, MD PhD, 0034934893000, marc.ribo@vhir.org
Marta Rubiera, MD PhD, marta.rubiera@vhir.org
About this study
Official title: SAIL-MEVO: Endovascular Treatment Versus Best Medical Therapy for Distal Vessel Occlusions - Randomized Controlled Trial
Patients with acute ischemic stroke caused by distal or medium vessel occlusions (MeVOs) may experience significant disability despite receiving the current standard medical treatment. Although endovascular treatment (EVT) is an established therapy for large vessel occlusions, its benefit in MeVO stroke remains uncertain.
The SAIL-MEVO trial is a prospective, multicenter, randomized controlled trial designed to evaluate whether EVT combined with best medical therapy improves functional outcomes compared with best medical therapy alone in selected patients with acute ischemic stroke due to MeVO. Eligible participants will be randomized in a 1:1 ratio to receive either best medical therapy alone or best medical therapy plus EVT using a standardized stepwise approach consisting of aspiration thrombectomy (ADAPT) followed, when necessary, by the SAIL technique (stent retriever-assisted intra-arterial lysis).
The primary objective is to determine whether EVT increases the proportion of patients achieving functional independence (modified Rankin Scale score 0-2) at 90 days after stroke. Secondary objectives include assessment of neurological recovery, infarct volume, quality of life, patient-reported outcomes, safety, and procedural outcomes.
Read the detailed description
Acute ischemic stroke due to medium and distal vessel occlusions (MeVOs) represents a substantial proportion of ischemic strokes. While endovascular treatment (EVT) is the standard of care for proximal large vessel occlusions, recent randomized trials have not demonstrated a consistent clinical benefit of EVT in MeVO populations. These neutral findings may reflect the heterogeneity of MeVO stroke, variability in patient selection, and differences in vascular anatomy and procedural complexity.
The SAIL-MEVO trial is an investigator-initiated, prospective, multicenter, randomized, open-label, blinded-endpoint (PROBE) trial designed to evaluate whether optimized EVT improves functional outcomes compared with best medical therapy (BMT) alone in carefully selected patients with acute ischemic stroke due to MeVO.
Participants aged 18 to 80 years presenting within 12 hours from symptom onset with an isolated distal vessel occlusion (non-dominant M2-M3 middle cerebral artery, A2-A3 anterior cerebral artery, or P2-P3 posterior cerebral artery), baseline NIHSS score between 9 and 17, ASPECTS ≥6, and an AI-predicted infarct core volume <10 mL on non-contrast CT will be eligible for enrollment.
Participants will be randomized in a 1:1 ratio to:
Best medical therapy (BMT) according to current stroke guidelines, including intravenous thrombolysis when indicated; or Best medical therapy plus endovascular treatment (EVT).
The EVT strategy consists of a standardized stepwise approach. Primary aspiration thrombectomy (ADAPT) will be performed first using a small-caliber distal aspiration catheter. If aspiration is unsuccessful or vascular anatomy prevents adequate catheter access, treatment will proceed using the SAIL technique, consisting of low-profile stent retriever deployment with localized intra-arterial thrombolysis according to the study operations manual.
The primary efficacy endpoint is functional independence, defined as a modified Rankin Scale (mRS) score of 0-2 at 90 days after randomization.
Secondary efficacy endpoints include ordinal mRS shift, excellent functional outcome (mRS 0-1), early neurological improvement, infarct volume at 24-48 hours, discharge disposition, hospital length of stay, health-related quality of life (EQ-5D-5L), return to work or usual activities, and patient-reported outcome measures.
Safety endpoints include symptomatic intracranial hemorrhage, any intracranial hemorrhage, subarachnoid hemorrhage, embolization to new territory, vessel perforation or dissection, access-site complications, device- or procedure-related serious adverse events, all-cause mortality, and serious adverse events through 90 days.
Approximately 420 participants will be enrolled across up to 10 comprehensive stroke centers. Clinical outcomes will be assessed by investigators blinded to treatment allocation, and imaging endpoints will be adjudicated by an independent central imaging core laboratory. An independent Data and Safety Monitoring Board (DSMB) will oversee participant safety throughout the study.
- Conditions
- Medium Vessel Occlusion Stroke (MeVO), Stroke Acute, Acute Ischemic Stroke, Cerebral Artery Occlusion
- Being tested
- best medical therapy, Endovascular Treatment
- Keywords
- Distal Vessel Occlusion, Medium Vessel Occlusion, MeVO, Endovascular Treatment, Mechanical Thrombectomy, Aspiration Thrombectomy, ADAPT, SAIL, Intra-Arterial Thrombolysis, Randomized Controlled Trial, Acute Ischemic Stroke, Modified Rankin Scale, NIHSS, AI Imaging, Infarct Core, Neurointervention, Stroke, PROBE Trial
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
best medical therapyProcedure or surgery
Guideline-based medical management for acute ischemic stroke, including intravenous thrombolysis when clinically indicated according to local and international stroke guidelines.
Endovascular TreatmentProcedure or surgery
Endovascular treatment using a standardized stepwise protocol. Primary aspiration thrombectomy (ADAPT) is performed first using a small-caliber distal aspiration catheter. When aspiration is unsuccessful or vascular anatomy is unfavorable, treatment proceeds with the SAIL technique, consisting of deployment of a low-profile stent retriever with localized intra-arterial thrombolysis according to the study operations manual.
| Study group | Role | What they receive |
|---|---|---|
| Best Medical Therapy (BMT) | Active comparator | Participants receive guideline-based best medical therapy for acute ischemic stroke, including intravenous thrombolysis when indicated according to current clinical guidelines. Receives: Procedure: best medical therapy |
| Endovascular Treatment Plus Best Medical Therapy (EVT + BMT) | Experimental | Participants receive guideline-based best medical therapy plus endovascular treatment. The endovascular strategy consists of a standardized stepwise approach using aspiration thrombectomy (ADAPT) as the first-line technique, followed by the SAIL technique (low-profile stent retriever with localized intra-arterial thrombolysis) when aspiration is unsuccessful or vascular anatomy is unfavorable. Receives: Procedure: best medical therapy; Procedure: Endovascular Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence at 90 Days
Proportion of participants achieving functional independence, defined as a modified Rankin Scale (mRS, range 0 to 6, lower better) score of 0-2, assessed 90 (±14) days after randomization.
Measured: Assessment at 90 (±14) days after randomization
Secondary outcomes (8)
Ordinal Modified Rankin Scale (mRS) Score
Distribution of modified Rankin Scale (mRS, range 0 to 6, lower better) scores
Measured: Assessment at 90 (±14) days after randomization
Excellent Functional Outcome (mRS 0-1)
Proportion of participants achieving a modified Rankin Scale (mRS, range 0-6, lower better) score of 0-1.
Measured: Assessment at 90 (±14) days after randomization
Early Neurological Improvement
Proportion of patients acheiving an early neurological improvemente defined as a reduction in National Institute of Health Stroke Scale (NIHSS, range 0-42, lower better) score of ≥8 points from baseline or an absolute NIHSS ≤2 at 24 hours.
Measured: 24 hours after randomization
Infarct Volume
Infarct volume measured by the central imaging core laboratory.
Measured: 24-48 hours after randomization
Discharge Disposition
Discharge to home versus rehabilitation or other healthcare facility.
Measured: At hospital discharge (up to 15 days from randomization)
Length of Hospital Stay
Duration of hospitalization measured in days.
Measured: At hospital discharge (up to 15 days from randomization)
EQ-5D-5L Score
Health-related quality of life assessed by the EQ-5D-5L ((EuroQol 5-Dimension, 5-Level), descriptive system and EQ VAS). Two components will be reported: the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression - each evaluated from 1 to 5 (no sumatory). A lower level on a dimension indicates better health. EQ VAS (vertical visual analogue scale: ranging from 0 - 100. Higher scores indicate better health)
Measured: Assessment at 90 (±14) days after randomization
Return to Work or Usual Activities
Proportion of participants returning to work or usual daily activities.
Measured: Assesement at 90 days (+-14) after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medium Vessel Occlusion Stroke (MeVO)Studies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomized in a 1:1 ratio to receive either best medical therapy (BMT) alone or best medical therapy plus endovascular treatment (EVT). The EVT arm follows a standardized stepwise approach consisting of aspiration thrombectomy (ADAPT) followed by SAIL when aspiration is unsuccessful or vascular anatomy is unfavorable.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, Fundació Ictus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843797
- Sponsor's protocol ID
- SAIL-MEVO-RCT-V1.0
- Acronym
- SAIL MEVO
- Status last verified
- Nov 2026
- First submitted
- 16 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patients/representants have signed an informed consent that specifies that no sharing of personal data will be performed.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAIL-MEVO: Endovascular Treatment Versus Best Medical Therapy for Distal Vessel Occlusions - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07843797
- Acronym / sponsor ID
- SAIL MEVO / SAIL-MEVO-RCT-V1.0
- Conditions
- Medium Vessel Occlusion Stroke (MeVO), Stroke Acute, Acute Ischemic Stroke, Cerebral Artery Occlusion
- Keywords
- Distal Vessel Occlusion, Medium Vessel Occlusion, MeVO, Endovascular Treatment, Mechanical Thrombectomy, Aspiration Thrombectomy, ADAPT, SAIL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- University of Iowa, Fundació Ictus
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 28 Sep 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.
Patients with acute ischemic stroke caused by distal or medium vessel occlusions (MeVOs) may experience significant disability despite receiving the current standard medical treatment. Although endovascular treatment (EVT) is an established therapy for large vessel occlusions, its benefit in MeVO stroke remains uncertain.
The SAIL-MEVO trial is a prospective, multicenter, randomized controlled trial designed to evaluate whether EVT combined with best medical therapy improves functional outcomes compared with best medical therapy alone in selected patients with acute ischemic stroke due to MeVO. Eligible participants will be randomized in a 1:1 ratio to receive either best medical therapy alone or best medical therapy plus EVT using a standardized stepwise approach consisting of aspiration thrombectomy (ADAPT) followed, when necessary, by the SAIL technique (stent retriever-assisted intra-arterial lysis).
The primary objective is to determine whether EVT increases the proportion of patients achieving functional independence (modified Rankin Scale score 0-2) at 90 days after stroke. Secondary objectives include assessment of neurological recovery, infarct volume, quality of life, patient-reported outcomes, safety, and procedural outcomes.
Detailed description
Acute ischemic stroke due to medium and distal vessel occlusions (MeVOs) represents a substantial proportion of ischemic strokes. While endovascular treatment (EVT) is the standard of care for proximal large vessel occlusions, recent randomized trials have not demonstrated a consistent clinical benefit of EVT in MeVO populations. These neutral findings may reflect the heterogeneity of MeVO stroke, variability in patient selection, and differences in vascular anatomy and procedural complexity.
The SAIL-MEVO trial is an investigator-initiated, prospective, multicenter, randomized, open-label, blinded-endpoint (PROBE) trial designed to evaluate whether optimized EVT improves functional outcomes compared with best medical therapy (BMT) alone in carefully selected patients with acute ischemic stroke due to MeVO.
Participants aged 18 to 80 years presenting within 12 hours from symptom onset with an isolated distal vessel occlusion (non-dominant M2-M3 middle cerebral artery, A2-A3 anterior cerebral artery, or P2-P3 posterior cerebral artery), baseline NIHSS score between 9 and 17, ASPECTS ≥6, and an AI-predicted infarct core volume <10 mL on non-contrast CT will be eligible for enrollment.
Participants will be randomized in a 1:1 ratio to:
Best medical therapy (BMT) according to current stroke guidelines, including intravenous thrombolysis when indicated; or Best medical therapy plus endovascular treatment (EVT).
The EVT strategy consists of a standardized stepwise approach. Primary aspiration thrombectomy (ADAPT) will be performed first using a small-caliber distal aspiration catheter. If aspiration is unsuccessful or vascular anatomy prevents adequate catheter access, treatment will proceed using the SAIL technique, consisting of low-profile stent retriever deployment with localized intra-arterial thrombolysis according to the study operations manual.
The primary efficacy endpoint is functional independence, defined as a modified Rankin Scale (mRS) score of 0-2 at 90 days after randomization.
Secondary efficacy endpoints include ordinal mRS shift, excellent functional outcome (mRS 0-1), early neurological improvement, infarct volume at 24-48 hours, discharge disposition, hospital length of stay, health-related quality of life (EQ-5D-5L), return to work or usual activities, and patient-reported outcome measures.
Safety endpoints include symptomatic intracranial hemorrhage, any intracranial hemorrhage, subarachnoid hemorrhage, embolization to new territory, vessel perforation or dissection, access-site complications, device- or procedure-related serious adverse events, all-cause mortality, and serious adverse events through 90 days.
Approximately 420 participants will be enrolled across up to 10 comprehensive stroke centers. Clinical outcomes will be assessed by investigators blinded to treatment allocation, and imaging endpoints will be adjudicated by an independent central imaging core laboratory. An independent Data and Safety Monitoring Board (DSMB) will oversee participant safety throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either best medical therapy (BMT) alone or best medical therapy plus endovascular treatment (EVT). The EVT arm follows a standardized stepwise approach consisting of aspiration thrombectomy (ADAPT) followed by SAIL when aspiration is unsuccessful or vascular anatomy is unfavorable.
| Arm | Type | Receives |
|---|---|---|
| Best Medical Therapy (BMT) | Active comparator | Procedure: best medical therapyParticipants receive guideline-based best medical therapy for acute ischemic stroke, including intravenous thrombolysis when indicated according to current clinical guidelines. |
| Endovascular Treatment Plus Best Medical Therapy (EVT + BMT) | Experimental | Procedure: best medical therapy, Procedure: Endovascular TreatmentParticipants receive guideline-based best medical therapy plus endovascular treatment. The endovascular strategy consists of a standardized stepwise approach using aspiration thrombectomy (ADAPT) as the first-line technique, followed by the SAIL technique (low-profile stent retriever with localized intra-arterial thrombolysis) when aspiration is unsuccessful or vascular anatomy is unfavorable. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 80 years.
- Pre-stroke modified Rankin Scale (mRS) score of 0-1.
- Baseline NIH Stroke Scale (NIHSS) score between 9 and 17.
- Symptom onset to randomization less than 12 hours.
- Acute ischemic stroke due to an isolated medium/distal vessel occlusion involving a non-dominant M2-M3 middle cerebral artery, A2-A3 anterior cerebral artery, or P2-P3 posterior cerebral artery confirmed by CTA or MRA.
Key exclusion criteria (5 listed)
- Proximal large vessel occlusion (internal carotid artery or M1 segment) or tandem cervical internal carotid artery stenosis >70%.
- Intracranial hemorrhage at baseline imaging.
- Pregnancy.
- Life expectancy less than 3 months.
- Severe allergy to iodinated contrast media.
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 |
|---|---|---|
| best medical therapyGuideline-based medical management for acute ischemic stroke, including intravenous thrombolysis when clinically indicated according to local and international stroke guidelines. | Procedure or surgery | Best Medical Therapy (BMT), Endovascular Treatment Plus Best Medical Therapy (EVT + BMT) |
| Endovascular TreatmentEndovascular treatment using a standardized stepwise protocol. Primary aspiration thrombectomy (ADAPT) is performed first using a small-caliber distal aspiration catheter. When aspiration is unsuccessful or vascular anatomy is unfavorable, treatment proceeds with the SAIL technique, consisting of deployment of a low-profile stent retriever with localized intra-arterial thrombolysis according to the study operations manual. | Procedure or surgery | Endovascular Treatment Plus Best Medical Therapy (EVT + BMT) |
Primary outcome
Functional Independence at 90 Days
Time frame: Assessment at 90 (±14) days after randomization
Proportion of participants achieving functional independence, defined as a modified Rankin Scale (mRS, range 0 to 6, lower better) score of 0-2, assessed 90 (±14) days after randomization.
8 secondary outcomes
Ordinal Modified Rankin Scale (mRS) Score
Time frame: Assessment at 90 (±14) days after randomization
Excellent Functional Outcome (mRS 0-1)
Time frame: Assessment at 90 (±14) days after randomization
Early Neurological Improvement
Time frame: 24 hours after randomization
Infarct Volume
Time frame: 24-48 hours after randomization
Discharge Disposition
Time frame: At hospital discharge (up to 15 days from randomization)
Length of Hospital Stay
Time frame: At hospital discharge (up to 15 days from randomization)
EQ-5D-5L Score
Time frame: Assessment at 90 (±14) days after randomization
Return to Work or Usual Activities
Time frame: Assesement at 90 days (+-14) after randomization
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 4 Nov 2026.
- Individual participant dataSharing planned: No. The patients/representants have signed an informed consent that specifies that no sharing of personal data will be performed.
Related trials for Medium Vessel Occlusion Stroke (MeVO)
Not yet recruitingPhase 3
INTRA-ARTERIAL MeVO TREATMENT (IMP-ACT) Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
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RecruitingPhase 3
Intravenous Recombinant Human Prourokinase for Acute Medium Vessel Occlusion 4.5-24 Hours After Ischemic Stroke
Acute Ischemic Stroke
RecruitingPhase 3
OPtimizing REperfusion by Primary Intra-Arterial ThRomboLysis for Medium Vessel Occlusion
Acute Ischemic Stroke
RecruitingObservational study
PROMISE Registry: PROspective Study on Management of Ischemic Stroke Secondary to mEvo Registry
Management of Ischemic Stroke, Medium Vessel Occlusion
RecruitingPhase 3
Intra-arterial Tenecteplase for Acute Medium Vessel Occlusion Stroke
Ischemic Stroke, Medium Vessel Occlusion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing best medical therapy and Endovascular Treatment in people with Medium Vessel Occlusion Stroke (MeVO) and Stroke Acute, run by Hospital Universitari Vall d'Hebron Research Institute 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 7 inclusion and 5 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 4 Nov 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?
Contact Marc Ribo, MD, PhD (934 89 30 00, marcriboj@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independence at 90 Days (time frame: Assessment at 90 (±14) days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.