Acute Ischemic StrokeFOCUSNCT06485427
Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke
A study testing Selective Intra-arterial Cooling Infusion (IA-SCI) in people with Acute Ischemic Stroke and Hypothermia, run by Beijing Shijitan Hospital, Capital Medical University at 12 sites in China.
Trial summary
This is a multicenter, randomized, controlled, subject- and assessor-blinded clinical trial. The research objective is to evaluate the safety and efficacy of selective intra-arterial cooling infusion combined with endovascular therapy in the treatment of acute anterior circulation large vessel occlusion stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke, Hypothermia
- What is being tested?
- Selective Intra-arterial Cooling Infusion (IA-SCI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 12 sitesChina
- Study dates
- 3 Jul 2024to 1 Mar 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤80.
- Clinical signs consistent with AIS-LVO in the anterior circulation (intracranial segment of internal carotid artery, M1 segment of middle cerebral artery (MCA) demonstrated by computed tomography angiography (CTA) / magnetic resonance angiography (MRA)/ digital subtraction angiography (DSA)).
- National Institutes of Health Stroke Scale (NIHSS) score (at screening) ≥6 and ≤25.
- Modified Rankin Scale (mRS) score ≤1 before stroke onset.
- Arterial puncture performed within 24 hours of symptom onset or last known well (LKW).
- Written informed consent obtained from the patients or legally authorized representatives.
- For patients admitted to the hospital within 6 hours of symptom onset, an Alberta Stroke Program Early CT Score (ASPECTS) ≥6 is required. For those admitted between 6 and 24 hours, the neuroimaging criteria of the DAWN or DEFUSE-3 trials are applied.
Who cannot join
- Baseline CT/MRI reveals the presence of acute infarction in multiple vascular territories.
- CTA/MRA/DSA confirms the presence of arterial dissection.
- Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
- Known allergies or intolerances to antiplatelet agents, anticoagulants, iodinated contrast, or anesthetics.
- Severe infection (e.g., sepsis) or multiple organ failure.
- Known hereditary or acquired hemorrhagic diathesis; coagulation factor deficiency; recent oral anticoagulant therapy with international normalized ratio (INR)>3.
Show all 19Show fewer
- Exception: Time elapsed since the last use of a novel oral anticoagulant ≥48 hours plus a normal activated partial thromboplastin time (APTT).
- Baseline platelet count <50 × 109/L.
- Blood glucose concentration <50 mg/dL (2.7 mmol/L) or >400 mg/dL (22.2 mmol/L).
- Refractory hypertension that is difficult to control by medication (persistent systolic blood pressure (BP) >185 mmHg or diastolic BP >110 mmHg).
- Previous New York Heart Association (NYHA) functional classification >I.
- Coronary artery stenosis >70% or history of coronary artery bypass grafting.
- Undergoing hemodialysis or peritoneal dialysis; severe renal insufficiency with a glomerular filtration rate <30 mL/min or serum creatinine >220 mmol/L (2.5 mg/dL).
- Known intracranial aneurysm or cerebral arteriovenous malformation.
- Malignant brain tumor or central nervous system infection.
- Pre-existing neurological or psychiatric diseases that could confound the neurological or functional evaluations (e.g., dementia or mental illness)
- Pregnant or lactating at admission.
- Anticipated life expectancy <6 months.
- Current participation in another interventional drug or device study. For any other reasons, the responsible clinicians believe that the patient is not suitable for SI-AC.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing Chaoyang Hospital, Capital Medical University
Beijing
Beijing Shijitan Hospital, Capital Medical University
Beijing
Peking University Internation Hospital
Beijing
967 Hospital of the Joint Logistics Support Force of PLA
Dalian
Dalian Municipal Central Hospital
Dalian
Gansu Province Central Hospital
Gansu
The First Affiliated Hospital of Harbin Medical University
Ha’erbin
Zhejiang Provincial People's Hospital
Hangzhou
The Second Hospital and Clinical Medical School, Lanzhou University
Lanzhou, Gansu
Department of Neurosurgery, Nanshi Hospital of Nanyang
Nanyang, Henan
Affiliated Hospital of Inner Mongolia University for the Nationalities
Tongliao
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
About this study
Official title: Selective Intra-arterial Cooling Infusion With Endovascular Thrombectomy for Acute Ischemic Stroke: a Multicenter, Randomized, Controlled Trial
This is a multicenter, randomized, controlled, subject- and assessor-blinded clinical trial. The research objective is to evaluate the safety and efficacy of selective intra-arterial cooling infusion combined with endovascular therapy in the treatment of acute anterior circulation large vessel occlusion stroke. This trial aims to enroll 258 subjects. Patients assigned to the control group will receive best medical management (BMM) and endovascular therapy (EVT). Those in the selective intra-arterial cooling infusion group (IA-SCI group) will undergo selective intra-arterial cold saline infusion, in addition to BMM and EVT. Subjects will be interviewed face-to-face at randomization, 24±6 hours, 48±6 hours after randomization, 7±2 days/discharge. Telephone interviews/ face-to face interviews will be performed at 30±3 days and 90±7 days after randomization. The primary outcome is the distribution of Modified Rankin Score at 90±7days after randomization.
Read the detailed description
Acute ischemic stroke (AIS) is the leading cause of death and disability in China. Randomized trials involving patients with acute stroke due to large-artery occlusion in the anterior circulation have shown a benefit of endovascular therapy (EVT). Although EVT achieves successful recanalization in over 80% of patients, only 46% of patients are functionally independent (mRS 0-2) after the intervention . Therefore, new ancillary therapeutic strategies are needed to further improve the clinical outcomes.
Therapeutic systemic hypothermia has been suggested to be one such potential approach offering a viable neuroprotective strategy. However, several adverse events associated with the systematic hypothermia treatment have been reported. Those offset the therapeutic benefits of systemic hypothermia. Selective intra-arterial cooling infusion (IA-SCI) targets precisely the ischemic brain tissue with the infusion of hypothermic solutions. This approach induces a state of mild hypothermia in the ischemic region without causing substantial drops in core body temperature, thereby minimizing the incidence of systemic side effects. Previous studies have shown that IA-SCI with cold saline combined with EVT in AIS is safe and feasible.
Hence, the investigators design a multicenter, randomized, controlled, subject- and assessor-blinded clinical trial. The objective of this trial is to further explore the safety and efficacy of selective intra-arterial cooling infusion combined with EVT in the treatment of acute anterior circulation large vessel occlusion stroke, and 258 subjects will be enrolled. Subjects assigned to the control group will receive best medical management (BMM) and endovascular therapy (EVT). Those in the selective intra-arterial cooling infusion group (IA-SCI group) will undergo selective intra-arterial cold saline infusion, in addition to BMM and EVT. Subjects will be interviewed face-to-face at randomization, 24±6 hours, 48±6 hours after randomization, 7±2 days/discharge. Telephone interviews/ face-to face interviews will be performed at 30±3 days and 90±7 days after randomization. The primary outcome is the distribution of Modified Rankin Score at 90±7days after randomization.
- Conditions
- Acute Ischemic Stroke, Hypothermia
- Being tested
- Selective Intra-arterial Cooling Infusion (IA-SCI)
- Medical subject headings
- Ischemic Stroke, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Intra-arterial Cooling Infusion (IA-SCI)Procedure or surgery
Pre-recanalization: During the procedure, the micro-catheter is advanced over a micro-guide wire, traveling up through the neck until it reaches beyond the clot. A 50 mL cold 0.9% saline (4 ℃) is infused intro into the ischemic territory at a rate of 10 mL/min via the micro-catheter. This enables the cold solution to infuse into the ischemic territory prior to revascularization.
Post-recanalization: After recanalization, cold 0.9% saline (4 ℃) is reinfused into the vessel via the catheter at a rate of 22 mL/min for 10 min, repeated twice with a 10-minute interval between infusions.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Subjects will receive best medical management (BMM) plus endovascular therapy (EVT) according to the clinical guidelines. |
| IA-SCI group | Experimental | Subjects randomized to the IA-SCI group will receive selective intra-arterial cooling infusion plus BMM and EVT. Receives: Procedure: Selective Intra-arterial Cooling Infusion (IA-SCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of Modified Rankin scale
the distribution of Modified Rankin scale (mRS) [ranging from 0 (normal) to 6 (death)]
Measured: 90 ±7days
Secondary outcomes (21)
Percentage of functional independence (mRS scale 0-2)
the percentage of mRS scale 0-2 (Modified Rankin scale [ranging from 0 (normal) to 6 (death)])
Measured: 90 ±7days
Percentage of favorable outcome (mRS scale 0-1)
the percentage of mRS scale 0-1(Modified Rankin scale [ranging from 0 (normal) to 6 (death)])
Measured: 90 ±7days
Final infarction volume
The infarct area is defined as the low-density area. The infarct area is semi-automatically delineated by the software. The infarct volume= the sum of the infarct area of each layer × layer thickness (5mm).
Measured: 7±2 days/discharge
The changes of infarction volume
the changes of infarction volume between baseline and 7±2 days/discharge assessed by CT
Measured: 7±2 days/discharge
National Institute of Health stroke scale (NIHSS) score
National Institute of Health stroke scale (NIHSS) score [ranging from 0 to 42 points, with higher numbers indicating greater severity]
Measured: 7±2 days/discharge
Barthel Index score
the Barthel Index score [the sum of the score ranging from 0 to 100, with 100 being the most independent level of function]
Measured: 90±7 days
Rapid neurologic improvement
Rapid neurologic improvement is defined as a reduction of ≥8 on the National Institutes of Health Stroke Scale [ranging from 0 to 42 points, with higher numbers indicating greater severity] or National Institutes of Health Stroke Scale zero to one 24 hours after thrombectomy.
Measured: 24±12 hours
Changes in ipsilateral tympanic membrane temperature
Changes in ipsilateral tympanic membrane temperature before and after intra-arterial cooling infusion in the IA-SCI group.
Measured: during surgery.
Power spectral density (PSD) assessed by continuous electroencephalogram (EEG)
PSD is estimated using Welch's periodogram from EEG.
Measured: within 7±2 days/discharge
(delta+theta)/(alpha+beta) power ratio (DTABR) assessed by continuous electroencephalogram (EEG)
DTABR is calculated using the absolute power for each of spectral band on EEG.
Measured: within 7±2 days/discharge
Delta/alpha power ratio (DAR) assessed by continuous electroencephalogram (EEG)
DAR is calculated using the absolute power for each of spectral band on EEG.
Measured: within 7±2 days/discharge
Brain symmetry index (BSI) assessed by continuous electroencephalogram (EEG)
BSI is calculated using the power values from both left and right hemispheres from EEG.
Measured: within 7±2 days/discharge
Symptomatic intracranial hemorrhage
Defined as any intracranial hemorrhage accompanied by neurological deterioration (NIHSS score increased by more than 4 points compared with the lowest NIHSS score at enrollment or during hospitalization) or death caused by any cerebral hemorrhage according to the ECASS III study.
Measured: 24±12 hours
Any intracranial hemorrhage
any intracranial hemorrhage assessed by CT
Measured: 24±12 hours
Procedure-related complications
Including vascular injury, device-associated adverse events, and intracranial arterial vasospasm requiring further therapeutic intervention。
Measured: during operation
Proportion of subjects with pulmonary, urinary tract infection and gastroenteritis
the proportion of patients with pulmonary, urinary tract infection and gastroenteritis according to the Centers for Disease Control and Prevention (CDC)/ National Healthcare Safety Network (NHSN) criteria.
Measured: 7±2 days/discharge
Proportion of subjects with coagulation abnormalities
Defined as abnormal coagulation function
Measured: 24±12 hours
Proportion of subjects with electrolyte imbalance
Defined as any abnormal findings, including hypernatremia, hyponatremia, hyperkalemia, or hypokalemia.
Measured: 24±12 hours
Changes in core temperature before and after intra-arterial cooling infusion in the IA-SCI group.
Changes in rectal temperature before and after intra-arterial cooling infusion in the IA-SCI group.
Measured: During operation
any death
any death
Measured: 90±7 days
other AE/SAE
other adverse events/ serious adverse events
Measured: 90±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start3 Jul 2024
- Primary completion8 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Shijitan Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Li, Beijing Shijitan Hospital, Capital Medical University
- Investigators
- Shen Li, Principal investigator, Beijing Shijitan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485427
- Sponsor's protocol ID
- FOCUS
- Acronym
- FOCUS
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The deidentified individual participant data underlying this article will not be publicly available. However, the data may be made available to researchers upon reasonable request to the corresponding author, subject to approval by the institutional review board and execution of a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Intra-arterial Cooling Infusion With Endovascular Thrombectomy for Acute Ischemic Stroke: a Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06485427
- Acronym / sponsor ID
- FOCUS / FOCUS
- Conditions
- Acute Ischemic Stroke, Hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Beijing Shijitan Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 8 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 3 Jul 2024 (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.
This is a multicenter, randomized, controlled, subject- and assessor-blinded clinical trial. The research objective is to evaluate the safety and efficacy of selective intra-arterial cooling infusion combined with endovascular therapy in the treatment of acute anterior circulation large vessel occlusion stroke. This trial aims to enroll 258 subjects. Patients assigned to the control group will receive best medical management (BMM) and endovascular therapy (EVT). Those in the selective intra-arterial cooling infusion group (IA-SCI group) will undergo selective intra-arterial cold saline infusion, in addition to BMM and EVT. Subjects will be interviewed face-to-face at randomization, 24±6 hours, 48±6 hours after randomization, 7±2 days/discharge. Telephone interviews/ face-to face interviews will be performed at 30±3 days and 90±7 days after randomization. The primary outcome is the distribution of Modified Rankin Score at 90±7days after randomization.
Detailed description
Acute ischemic stroke (AIS) is the leading cause of death and disability in China. Randomized trials involving patients with acute stroke due to large-artery occlusion in the anterior circulation have shown a benefit of endovascular therapy (EVT). Although EVT achieves successful recanalization in over 80% of patients, only 46% of patients are functionally independent (mRS 0-2) after the intervention . Therefore, new ancillary therapeutic strategies are needed to further improve the clinical outcomes.
Therapeutic systemic hypothermia has been suggested to be one such potential approach offering a viable neuroprotective strategy. However, several adverse events associated with the systematic hypothermia treatment have been reported. Those offset the therapeutic benefits of systemic hypothermia. Selective intra-arterial cooling infusion (IA-SCI) targets precisely the ischemic brain tissue with the infusion of hypothermic solutions. This approach induces a state of mild hypothermia in the ischemic region without causing substantial drops in core body temperature, thereby minimizing the incidence of systemic side effects. Previous studies have shown that IA-SCI with cold saline combined with EVT in AIS is safe and feasible.
Hence, the investigators design a multicenter, randomized, controlled, subject- and assessor-blinded clinical trial. The objective of this trial is to further explore the safety and efficacy of selective intra-arterial cooling infusion combined with EVT in the treatment of acute anterior circulation large vessel occlusion stroke, and 258 subjects will be enrolled. Subjects assigned to the control group will receive best medical management (BMM) and endovascular therapy (EVT). Those in the selective intra-arterial cooling infusion group (IA-SCI group) will undergo selective intra-arterial cold saline infusion, in addition to BMM and EVT. Subjects will be interviewed face-to-face at randomization, 24±6 hours, 48±6 hours after randomization, 7±2 days/discharge. Telephone interviews/ face-to face interviews will be performed at 30±3 days and 90±7 days after randomization. The primary outcome is the distribution of Modified Rankin Score at 90±7days after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Subjects will receive best medical management (BMM) plus endovascular therapy (EVT) according to the clinical guidelines. |
| IA-SCI group | Experimental | Procedure: Selective Intra-arterial Cooling Infusion (IA-SCI)Subjects randomized to the IA-SCI group will receive selective intra-arterial cooling infusion plus BMM and EVT. |
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 and ≤80.
- Clinical signs consistent with AIS-LVO in the anterior circulation (intracranial segment of internal carotid artery, M1 segment of middle cerebral artery (MCA) demonstrated by computed tomography angiography (CTA) / magnetic resonance angiography (MRA)/ digital subtraction angiography (DSA)).
- National Institutes of Health Stroke Scale (NIHSS) score (at screening) ≥6 and ≤25.
- Modified Rankin Scale (mRS) score ≤1 before stroke onset.
- Arterial puncture performed within 24 hours of symptom onset or last known well (LKW).
Key exclusion criteria (19 listed)
- Baseline CT/MRI reveals the presence of acute infarction in multiple vascular territories.
- CTA/MRA/DSA confirms the presence of arterial dissection.
- Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
- Known allergies or intolerances to antiplatelet agents, anticoagulants, iodinated contrast, or anesthetics.
- Severe infection (e.g., sepsis) or multiple organ failure.
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 |
|---|---|---|
| Selective Intra-arterial Cooling Infusion (IA-SCI)Pre-recanalization: During the procedure, the micro-catheter is advanced over a micro-guide wire, traveling up through the neck until it reaches beyond the clot. A 50 mL cold 0.9% saline (4 ℃) is infused intro into the ischemic territory at a rate of 10 mL/min via the micro-catheter. This enables the cold solution to infuse into the ischemic territory prior to revascularization. Post-recanalization: After recanalization, cold 0.9% saline (4 ℃) is reinfused into the vessel via the catheter at a rate of 22 mL/min for 10 min, repeated twice with a 10-minute interval between infusions. | Procedure or surgery | IA-SCI group |
Primary outcome
Distribution of Modified Rankin scale
Time frame: 90 ±7days
the distribution of Modified Rankin scale (mRS) [ranging from 0 (normal) to 6 (death)]
21 secondary outcomes
Percentage of functional independence (mRS scale 0-2)
Time frame: 90 ±7days
Percentage of favorable outcome (mRS scale 0-1)
Time frame: 90 ±7days
Final infarction volume
Time frame: 7±2 days/discharge
The changes of infarction volume
Time frame: 7±2 days/discharge
National Institute of Health stroke scale (NIHSS) score
Time frame: 7±2 days/discharge
Barthel Index score
Time frame: 90±7 days
Rapid neurologic improvement
Time frame: 24±12 hours
Changes in ipsilateral tympanic membrane temperature
Time frame: during surgery.
Power spectral density (PSD) assessed by continuous electroencephalogram (EEG)
Time frame: within 7±2 days/discharge
(delta+theta)/(alpha+beta) power ratio (DTABR) assessed by continuous electroencephalogram (EEG)
Time frame: within 7±2 days/discharge
Delta/alpha power ratio (DAR) assessed by continuous electroencephalogram (EEG)
Time frame: within 7±2 days/discharge
Brain symmetry index (BSI) assessed by continuous electroencephalogram (EEG)
Time frame: within 7±2 days/discharge
Symptomatic intracranial hemorrhage
Time frame: 24±12 hours
Any intracranial hemorrhage
Time frame: 24±12 hours
Procedure-related complications
Time frame: during operation
Proportion of subjects with pulmonary, urinary tract infection and gastroenteritis
Time frame: 7±2 days/discharge
Proportion of subjects with coagulation abnormalities
Time frame: 24±12 hours
Proportion of subjects with electrolyte imbalance
Time frame: 24±12 hours
Changes in core temperature before and after intra-arterial cooling infusion in the IA-SCI group.
Time frame: During operation
any death
Time frame: 90±7 days
other AE/SAE
Time frame: 90±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 7 Jul 2026.
- Individual participant dataSharing planned: No. The deidentified individual participant data underlying this article will not be publicly available. However, the data may be made available to researchers upon reasonable request to the corresponding author, subject to approval by the institutional review board and execution of a data access 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. This study is not recruiting at the moment.
Shen Li principal investigator
Beijing Shijitan Hospital, Capital Medical University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Intra-arterial Cooling Infusion (IA-SCI) in people with Acute Ischemic Stroke and Hypothermia, run by Beijing Shijitan Hospital, Capital Medical University at 12 sites in China.
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 19 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. 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?
Distribution of Modified Rankin scale (time frame: 90 ±7days). 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 7 Jul 2026.