Ischemic Stroke, AcuteECAISNCT07195786
Expansion-floating Craniotomy for the Treatment of Malignant Cerebral Edema Caused by Acute Ischemic Stroke
An observational study of Ischemic Stroke, Acute and Malignant Cerebral Edema, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Trial summary
This clinical study investigates Expansion-floating Craniotomy (EC), a novel surgical technique for treating life-threatening malignant cerebral edema following large hemispheric infarction (commonly known as massive stroke). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Acute, Malignant Cerebral Edema
- What is being tested?
- Expansion-floating Craniotomy, decompressive craniectomy and drug conservative therapeutic
- Type of treatment
- Surgery or procedure
- How many people
- 356 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 30 May 2027
- How long will I take part?
- 3 Months
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects developing malignant cerebral edema after acute cerebral infarction
Who may be able to join
- Age requirement: Adults aged >18 but <80 years
- Acute cerebral infarction diagnosis: Patients with internal carotid artery or middle cerebral artery occlusion within 48 hours, meeting all three criteria:
- NIHSS score ≥16 with item 1a (level of consciousness) ≥1 CT demonstrating >50% MCA territory infarction or hypoperfused area >2/3, OR DWI hyperintensity volume >82 ml within 6 hours of onset, OR DWI infarct volume >145 ml within 14 hours
- Imaging evidence: Midline shift ≥5 mm to the contralateral side on CT, OR significant ipsilateral ventricular compression with effacement of cerebral sulci/cisterns.
Who cannot join
- Pre-stroke mRS score ≥1
- Significant contralateral cerebral infarction
- Symptomatic intracranial hemorrhage
- Any known coagulopathy
- Life expectancy <3 years
- Any severe comorbidities potentially interfering with treatment evaluation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Expansion-floating Craniotomy for the Treatment of Malignant Cerebral Edema Caused by Acute Ischemic Stroke--A Prospective, Multicenter, Non-inferiority,Cohort Study（ECAIS）
This clinical study investigates Expansion-floating Craniotomy (EC), a novel surgical technique for treating life-threatening malignant cerebral edema following large hemispheric infarction (commonly known as massive stroke). Malignant edema causes rapid increases in intracranial pressure, compressing vital brain structures and risking fatal brain herniation, requiring urgent intervention.
The current international standard treatment is traditional decompressive craniectomy (DC). DC involves removing a section of the skull to allow brain swelling, effectively reducing pressure and mortality risk. It is strongly recommended (Class I, Level A evidence) in major guidelines. However, DC typically requires a second major surgery (cranioplasty) approximately 3 months later to replace the removed bone flap, involving additional costs and risks like progressive intracranial hemorrhage or subdural hygroma.
Read more
EC is a newer approach designed to potentially eliminate the need for a second surgery. During EC, surgeons use medical titanium plates to temporarily elevate the bone flap, creating immediate space for brain swelling while keeping the bone flap attached. Once brain swelling subsides (usually within weeks), a minor procedure flattens the titanium plates, allowing the patient's own bone to naturally reposition without requiring cranioplasty. EC may be performed based on surgeon assessment of brain swelling, guideline considerations, or experience. If EC is deemed unsuitable during surgery, DC will be performed instead.
While early research suggests EC achieves decompression similar to DC while preserving the bone flap, its safety and effectiveness compared to the established DC procedure are not yet fully proven. DC is a well-understood, mature technique with known risks and benefits, including the certainty of needing cranioplasty. Conservative management is reserved for patients unfit for surgery but may not prevent neurological deterioration.This study aims to conduct a preliminary assessment of the outcomes of EC versus DC.
Read the detailed description
Extensive cerebral infarction leads to progressive brain edema within 24-48 hours of ischemic injury. This edema can cause secondary damage over subsequent days through elevated intracranial pressure (ICP) and brain herniation. When edema is severe enough to cause decompensated ICP elevation, it is termed malignant edema, which can compromise potentially salvageable peri-infarct penumbral tissue.
Decompressive craniectomy (DC) is widely used to alleviate elevated ICP and prevent herniation. Cochrane reviews incorporating data from three major randomized trials (DECIMAL, DESTINY, HAMLET) demonstrate that DC improves survival and favorable outcomes compared to medical management alone. However, morbidity associated with DC and subsequent cranioplasty is significant, reaching up to 40%. Complications include delayed postoperative seizures (reported in 37-61.1% of cases), hydrocephalus (40%), neurological deficits like the syndrome of the trephined (26%), and chronic headaches often resolving only after cranioplasty (17%). Specific complication rates reported by Ban et al. include contralateral hematoma (5.6%), contusion expansion (12.4%), postoperative seizures (3.4%), external brain herniation (14.6%), CSF leakage (2.2%), infection (4.5%), subdural hygroma (32.6%), post-traumatic hydrocephalus (11.2%), and syndrome of the trephined (9.0%).
To address the limitations of DC, techniques like decompressive cranioplasty (DCP), also known as hinge craniotomy (HC), have been proposed. Unlike DC, HC preserves the bone flap, suspending it above the skull using specific fixation devices to avoid the long-term sequelae of bone removal. HC aims to reduce elevated ICP, prevent worsening edema and herniation, reduce the complexity of subsequent cranioplasty, and offer potential cost benefits. First described in 2007 for refractory post-traumatic ICP, HC has been used off-label for other indications. Potential advantages over DC include controlling moderate edema while avoiding a second major cranioplasty surgery, a crucial factor in resource-limited settings, and potentially lower complication rates.
However, HC may have limitations, primarily concerning the adequacy of the achieved expansion volume and potential subsequent need for conversion to DC. Early HC techniques reportedly provided only 40-60ml of expansion, potentially insufficient for malignant edema, though recent modifications claim volumes of 100-120ml. While some studies suggest comparable ICP control between HC and DC, rigorous data on HC's safety and efficacy, particularly its ability to sufficiently mitigate midline shift, brain swelling, and prevent herniation in large hemispheric infarctions, remain limited and require validation through systematic clinical studies.
Our team recently reported a novel technique termed Expansion-floating Craniotomy (EC). EC utilizes three peptide plates to elevate the bone flap to a predetermined position, ensuring adequate decompression while preserving the potential for outward displacement. As cerebral swelling subsides, subsequent loosening of the plates allows the bone flap to spontaneously reposition. EC was successfully implemented in four emergency cases, achieving the desired decompression volume while preserving the bone flap. This technique aims to provide optimal decompression without bone removal, potentially reducing complications associated with prior techniques. Potential advantages include superior cosmetic outcomes, maintenance of appropriate ICP, cost reduction, and simplified bone flap repositioning.
Study Design: This is a multicenter, non-inferiority cohort study. Patients with acute, large anterior circulation ischemic stroke will be allocated to one of three groups based on family consent:
Expansion-floating Craniotomy (EC) Group Decompressive Craniectomy (DC) Group Conservative Management Group
Objectives:
To evaluate the non-inferiority of EC compared to DC in treating patients with acute large anterior circulation infarction.
To further explore the clinical acceptability of the EC technique.
To assess differences in the postoperative complication profile, including:
Delayed intracranial hemorrhage (confirmed by CT >72 hours post-op) Incisional infection / CSF leakage rate Incidence of paradoxical brain herniation
- Conditions
- Ischemic Stroke, Acute, Malignant Cerebral Edema
- Being tested
- Expansion-floating Craniotomy, decompressive craniectomy, drug conservative therapeutic
- Keywords
- Expansion-floating Craniotomy, Malignant Cerebral Edema, decompressive craniectomy, Acute Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expansion-floating CraniotomyProcedure or surgery
Following craniotomy with bone flap removal, cerebral edema is assessed. The bone flap is then elevated using 2-3 titanium connectors. The elevation height must be sufficient to at least prevent contact between the bone flap and the underlying brain tissue. If cerebral swelling proves less severe than anticipated or begins to subside, the connectors can be loosened minimally invasively after a maximum scalp expansion period of 7-10 days. The elevated bone flap gradually repositions itself. Mild compression is applied using an elastic bandage for fixation, thereby restoring cranial integrity.
decompressive craniectomyProcedure or surgery
The patient is placed supine with the head rotated contralaterally. A large retroauricular question-mark incision is made in the scalp. Alternatively, a Kempe incision or preauricular incision may be used according to surgeon preference. Meticulous preservation of the superficial temporal artery (STA) is essential during the procedure to prevent ischemic complications in the flap. After elevating the myocutaneous flap to expose the operative field, a fronto-temporo-parietal craniectomy is performed. For unilateral decompressive craniectomy, the bone window should measure at least 15 × 12 cm, extending inferiorly to the floor of the temporal fossa to ensure adequate decompression.
drug conservative therapeuticDrug
Pharmacotherapy for malignant cerebral edema has been implemented according to current guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Expansion-floating Craniotomy (EC) is performed, preserving the bone flap, while suspending it above the skull using specific fixation devices. Receives: Procedure: Expansion-floating Craniotomy | |
| Standard treatment control group | Decompressive Craniectomy (DC) is performed, removing a section of skull bone to reduce intracranial pressure (ICP). Receives: Procedure: decompressive craniectomy | |
| Conservative treatment group | Conservative pharmacological therapy was administered instead, as surgical intervention indicated per guidelines was refused by the patient or family. Receives: Drug: drug conservative therapeutic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcomes assessed by the modified Rankin Scale (mRS) were dichotomized into scores 0-4 versus 5 and 6
Measured: 3 months
Secondary outcomes (7)
Median survival time
Median survival time (estimated by Kaplan-Meier method, from enrollment to death from any cause)
Measured: 3 months
Overall mortality
Overall mortality（death from any cause）
Measured: 3 months
Time interval from initial surgery to bone flap reimplantation or Expansion-Suspension Technique fixation (if applicable)
Measured: 3 months
Incidence of procedure-related complications
occurring after initial surgery or bone flap reimplantation, including: Transfusion-requiring surgical hemorrhage Anesthesia-related adverse events Pharmacologically-managed pain Impaired wound healing or surgical site infection Cerebrospinal fluid (CSF) leakage Abscess formation Any secondary complications prolonging hospitalization or requiring readmission (e.g., thrombosis, systemic infection, embolism
Measured: 3 months
The Short-From-36 Health Survey（SF-36）
The SF-36 can be self-administered, completed by others, or conducted via telephone interview. The assessment typically takes 5 to 10 minutes, though it may require up to 15 minutes for older adults. Scoring involves calculating the sum of item scores across each subscale, weighted according to specific criteria, to obtain a raw subscale score. This raw score is then converted into a standardized score ranging from 0 to 100. Higher scores indicate better quality of life.
Measured: 3 months
Hamilton Depression Scale
The Hamilton Depression Rating Scale is an observer-rated measure. Trained raters assess patients' symptoms and assign scores accordingly. It effectively reflects the severity of depression: milder symptoms correspond to lower total scores, while more severe symptoms result in higher total scores.We use 24-item version: Total score ≥35 points may indicate severe depression; Total score ≥20 points may indicate mild or moderate depression; Total score ≤8 points may indicate no depressive symptoms.
Measured: 3 months
Barthel Index
Total Score Range: 0-100 points. Higher scores indicate greater self-care ability.
Level Classification:
Heavily Dependent: Total score ≤ 40 points. Requires comprehensive nursing care.
Moderately Dependent: 41-60 points. Requires assistance for most activities. Mildly Dependent: 61-99 points. Requires minimal assistance. Independent: 100 points. Fully self-sufficient. Higher scores indicate better functional ability.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies 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
- 356 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195786
- Sponsor's protocol ID
- 2025-230
- Acronym
- ECAIS
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expansion-floating Craniotomy for the Treatment of Malignant Cerebral Edema Caused by Acute Ischemic Stroke--A Prospective, Multicenter, Non-inferiority,Cohort Study（ECAIS）
- ClinicalTrials.gov ID
- NCT07195786
- Acronym / sponsor ID
- ECAIS / 2025-230
- Conditions
- Ischemic Stroke, Acute, Malignant Cerebral Edema
- Keywords
- Expansion-floating Craniotomy, Malignant Cerebral Edema, decompressive craniectomy, Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 29 Sep 2025 (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 clinical study investigates Expansion-floating Craniotomy (EC), a novel surgical technique for treating life-threatening malignant cerebral edema following large hemispheric infarction (commonly known as massive stroke). Malignant edema causes rapid increases in intracranial pressure, compressing vital brain structures and risking fatal brain herniation, requiring urgent intervention.
The current international standard treatment is traditional decompressive craniectomy (DC). DC involves removing a section of the skull to allow brain swelling, effectively reducing pressure and mortality risk. It is strongly recommended (Class I, Level A evidence) in major guidelines. However, DC typically requires a second major surgery (cranioplasty) approximately 3 months later to replace the removed bone flap, involving additional costs and risks like progressive intracranial hemorrhage or subdural hygroma.
EC is a newer approach designed to potentially eliminate the need for a second surgery. During EC, surgeons use medical titanium plates to temporarily elevate the bone flap, creating immediate space for brain swelling while keeping the bone flap attached. Once brain swelling subsides (usually within weeks), a minor procedure flattens the titanium plates, allowing the patient's own bone to naturally reposition without requiring cranioplasty. EC may be performed based on surgeon assessment of brain swelling, guideline considerations, or experience. If EC is deemed unsuitable during surgery, DC will be performed instead.
While early research suggests EC achieves decompression similar to DC while preserving the bone flap, its safety and effectiveness compared to the established DC procedure are not yet fully proven. DC is a well-understood, mature technique with known risks and benefits, including the certainty of needing cranioplasty. Conservative management is reserved for patients unfit for surgery but may not prevent neurological deterioration.This study aims to conduct a preliminary assessment of the outcomes of EC versus DC.
Detailed description
Extensive cerebral infarction leads to progressive brain edema within 24-48 hours of ischemic injury. This edema can cause secondary damage over subsequent days through elevated intracranial pressure (ICP) and brain herniation. When edema is severe enough to cause decompensated ICP elevation, it is termed malignant edema, which can compromise potentially salvageable peri-infarct penumbral tissue.
Decompressive craniectomy (DC) is widely used to alleviate elevated ICP and prevent herniation. Cochrane reviews incorporating data from three major randomized trials (DECIMAL, DESTINY, HAMLET) demonstrate that DC improves survival and favorable outcomes compared to medical management alone. However, morbidity associated with DC and subsequent cranioplasty is significant, reaching up to 40%. Complications include delayed postoperative seizures (reported in 37-61.1% of cases), hydrocephalus (40%), neurological deficits like the syndrome of the trephined (26%), and chronic headaches often resolving only after cranioplasty (17%). Specific complication rates reported by Ban et al. include contralateral hematoma (5.6%), contusion expansion (12.4%), postoperative seizures (3.4%), external brain herniation (14.6%), CSF leakage (2.2%), infection (4.5%), subdural hygroma (32.6%), post-traumatic hydrocephalus (11.2%), and syndrome of the trephined (9.0%).
To address the limitations of DC, techniques like decompressive cranioplasty (DCP), also known as hinge craniotomy (HC), have been proposed. Unlike DC, HC preserves the bone flap, suspending it above the skull using specific fixation devices to avoid the long-term sequelae of bone removal. HC aims to reduce elevated ICP, prevent worsening edema and herniation, reduce the complexity of subsequent cranioplasty, and offer potential cost benefits. First described in 2007 for refractory post-traumatic ICP, HC has been used off-label for other indications. Potential advantages over DC include controlling moderate edema while avoiding a second major cranioplasty surgery, a crucial factor in resource-limited settings, and potentially lower complication rates.
However, HC may have limitations, primarily concerning the adequacy of the achieved expansion volume and potential subsequent need for conversion to DC. Early HC techniques reportedly provided only 40-60ml of expansion, potentially insufficient for malignant edema, though recent modifications claim volumes of 100-120ml. While some studies suggest comparable ICP control between HC and DC, rigorous data on HC's safety and efficacy, particularly its ability to sufficiently mitigate midline shift, brain swelling, and prevent herniation in large hemispheric infarctions, remain limited and require validation through systematic clinical studies.
Our team recently reported a novel technique termed Expansion-floating Craniotomy (EC). EC utilizes three peptide plates to elevate the bone flap to a predetermined position, ensuring adequate decompression while preserving the potential for outward displacement. As cerebral swelling subsides, subsequent loosening of the plates allows the bone flap to spontaneously reposition. EC was successfully implemented in four emergency cases, achieving the desired decompression volume while preserving the bone flap. This technique aims to provide optimal decompression without bone removal, potentially reducing complications associated with prior techniques. Potential advantages include superior cosmetic outcomes, maintenance of appropriate ICP, cost reduction, and simplified bone flap repositioning.
Study Design: This is a multicenter, non-inferiority cohort study. Patients with acute, large anterior circulation ischemic stroke will be allocated to one of three groups based on family consent:
Expansion-floating Craniotomy (EC) Group Decompressive Craniectomy (DC) Group Conservative Management Group
Objectives:
To evaluate the non-inferiority of EC compared to DC in treating patients with acute large anterior circulation infarction.
To further explore the clinical acceptability of the EC technique.
To assess differences in the postoperative complication profile, including:
Delayed intracranial hemorrhage (confirmed by CT >72 hours post-op) Incisional infection / CSF leakage rate Incidence of paradoxical brain herniation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Procedure: Expansion-floating CraniotomyExpansion-floating Craniotomy (EC) is performed, preserving the bone flap, while suspending it above the skull using specific fixation devices. |
| Standard treatment control group | – | Procedure: decompressive craniectomyDecompressive Craniectomy (DC) is performed, removing a section of skull bone to reduce intracranial pressure (ICP). |
| Conservative treatment group | – | Drug: drug conservative therapeuticConservative pharmacological therapy was administered instead, as surgical intervention indicated per guidelines was refused by the patient or family. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects developing malignant cerebral edema after acute cerebral infarction
Key inclusion criteria (4 listed)
- Age requirement: Adults aged >18 but <80 years
- Acute cerebral infarction diagnosis: Patients with internal carotid artery or middle cerebral artery occlusion within 48 hours, meeting all three criteria:
- NIHSS score ≥16 with item 1a (level of consciousness) ≥1 CT demonstrating >50% MCA territory infarction or hypoperfused area >2/3, OR DWI hyperintensity volume >82 ml within 6 hours of onset, OR DWI infarct volume >145 ml within 14 hours
- Imaging evidence: Midline shift ≥5 mm to the contralateral side on CT, OR significant ipsilateral ventricular compression with effacement of cerebral sulci/cisterns.
Key exclusion criteria (6 listed)
- Pre-stroke mRS score ≥1
- Significant contralateral cerebral infarction
- Symptomatic intracranial hemorrhage
- Any known coagulopathy
- Life expectancy <3 years
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 |
|---|---|---|
| Expansion-floating CraniotomyFollowing craniotomy with bone flap removal, cerebral edema is assessed. The bone flap is then elevated using 2-3 titanium connectors. The elevation height must be sufficient to at least prevent contact between the bone flap and the underlying brain tissue. If cerebral swelling proves less severe than anticipated or begins to subside, the connectors can be loosened minimally invasively after a maximum scalp expansion period of 7-10 days. The elevated bone flap gradually repositions itself. Mild compression is applied using an elastic bandage for fixation, thereby restoring cranial integrity. | Procedure or surgery | Treatment group |
| decompressive craniectomyThe patient is placed supine with the head rotated contralaterally. A large retroauricular question-mark incision is made in the scalp. Alternatively, a Kempe incision or preauricular incision may be used according to surgeon preference. Meticulous preservation of the superficial temporal artery (STA) is essential during the procedure to prevent ischemic complications in the flap. After elevating the myocutaneous flap to expose the operative field, a fronto-temporo-parietal craniectomy is performed. For unilateral decompressive craniectomy, the bone window should measure at least 15 × 12 cm, extending inferiorly to the floor of the temporal fossa to ensure adequate decompression. | Procedure or surgery | Standard treatment control group |
| drug conservative therapeuticPharmacotherapy for malignant cerebral edema has been implemented according to current guidelines. | Drug | Conservative treatment group |
Primary outcome
Functional outcomes assessed by the modified Rankin Scale (mRS) were dichotomized into scores 0-4 versus 5 and 6
Time frame: 3 months
7 secondary outcomes
Median survival time
Time frame: 3 months
Overall mortality
Time frame: 3 months
Time interval from initial surgery to bone flap reimplantation or Expansion-Suspension Technique fixation (if applicable)
Time frame: 3 months
Incidence of procedure-related complications
Time frame: 3 months
The Short-From-36 Health Survey（SF-36）
Time frame: 3 months
Hamilton Depression Scale
Time frame: 3 months
Barthel Index
Time frame: 3 months
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 29 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, Acute and Malignant Cerebral Edema, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Meng Zhang, Chief Physician, Professor (86+13708332600, zhangmeng861@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcomes assessed by the modified Rankin Scale (mRS) were dichotomized into scores 0-4 versus 5 and 6 (time frame: 3 months). 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 29 Sep 2025.