Acute Ischemic StrokeFACTORNCT07747701
Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation Monitoring
A study testing NIRS-based cerebral oxygenation and blood pressure monitoring and Carotid compression test in people with Acute Ischemic Stroke and Cerebral Autoregulation, run by Beijing Shijitan Hospital, Capital Medical University at 4 sites in China.
Trial summary
This multicenter, prospective, and interventional diagnostic accuracy study enrolls patients undergoing thrombectomy with intraoperative cerebral autoregulation monitoring and follows them up at predefined time points up to 90 days post-enrollment.This study aims to evaluate a monitoring system based on cerebral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Cerebral Autoregulation
- What is being tested?
- NIRS-based cerebral oxygenation and blood pressure monitoring and Carotid compression test
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 4 sitesChina
- Study dates
- 31 Jul 2026to 5 Feb 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Diagnosis of acute ischemic stroke caused by anterior circulation large vessel occlusion (intracranial internal carotid artery or M1 segment of the middle cerebral artery).
- National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 at presentation.
- Pre-stroke modified Rankin Scale (mRS) score ≤ 1.
- Symptom onset ≤ 24 hours.
- For patients with symptom onset within 6 hours: ASPECTS ≥ 6; for patients with symptom onset between 6 and 24 hours: age ≤ 80 years and ASPECTS ≥ 3.
- Underwent mechanical thrombectomy and achieved successful recanalization (mTICI 2b-3).
- Patient or legally authorized representative provides written informed consent.
Who cannot join
- Pre-procedural baseline imaging showing significant intracranial hemorrhagic transformation, intracranial arterial dissection, large chronic cerebral infarction, or intracranial metastasis from malignant tumors.
- Any degree of stenosis, plaque, dissection, severe tortuosity, or imaging evidence of unstable/vulnerable plaque in the target-side or bilateral common carotid artery or the origin of the internal carotid artery.
- Known history of carotid sinus hypersensitivity syndrome, severe autonomic dysfunction, sick sinus syndrome, high-grade atrioventricular conduction block, or other malignant arrhythmias.
- Refractory malignant hypertensive crisis (systolic blood pressure persistently ≥ 200 mmHg despite standardized intravenous antihypertensive therapy, or hemodynamic instability with shock).
- Known severe allergy to contrast agents or anesthetic drugs, or contraindications to antiplatelet/anticoagulation therapy.
- Severe systemic active infection, multiple organ failure, or expected survival < 6 months.
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- Severe hepatic or renal dysfunction (ALT/AST > 3× upper limit of normal; estimated glomerular filtration rate < 30 mL/min) or severe coagulation disorders (platelet count < 40 × 10⁹/L, APTT > 50 s, INR > 3.0).
- Blood glucose < 2.7 mmol/L or > 22.2 mmol/L.
- Heart failure with NYHA class > II, or persistent systolic blood pressure < 100 mmHg.
- Central nervous system infection or intracranial tumor.
- Unstable vital signs.
- Severe alcohol dependence or drug dependence.
- Cognitive impairment or psychiatric disorders that may affect follow-up assessments.
- Pregnant or breastfeeding women.
- Participation in another clinical drug or device study within the past 30 days.
- Local skin damage or other conditions preventing proper placement of monitoring electrodes.
- Severe agitation or other conditions that interfere with data acquisition.
- Any other condition judged by investigators to potentially affect study results.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing Shijitan Hospital, Capital Medical University
Beijing
Shen Li, 010-63925616, lishen@mail.ccmu.edu.cn
Shen Li
- Recruiting
Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)
Dalian
Xiaoyan Lan, +86 15840985380, jinnerlan@hotmail.com
Xiaoyan Lan
- Not yet recruiting
The First Affiliated Hospital of Harbin Medical University
Heilongjiang
Guang Zhang, +86 13945085063, Zhangguang@hrbmu.edu.cn
Guang Zhang
- Recruiting
Weifang People's Hospital Affiliated to Weifang Medical University
Shandong
Weili Li, +86 15169697295, liweili0536@163.com
Weili Li
About this study
Official title: Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation Monitoring: a Multicenter, Prospective, Interventional Study
This multicenter, prospective, and interventional diagnostic accuracy study enrolls patients undergoing thrombectomy with intraoperative cerebral autoregulation monitoring and follows them up at predefined time points up to 90 days post-enrollment.This study aims to evaluate a monitoring system based on cerebral autoregulation function and explore its predictive value for adverse neurological outcomes at the ultra-early stage following mechanical thrombectomy.
- Conditions
- Acute Ischemic Stroke, Cerebral Autoregulation
- Being tested
- NIRS-based cerebral oxygenation and blood pressure monitoring, Carotid compression test
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS-based cerebral oxygenation and blood pressure monitoringDevice
Bedside multimodal cerebral autoregulation monitoring performed immediately after successful mechanical thrombectomy (mTICI 2b-3). Monitoring includes continuous near-infrared spectroscopy (NIRS) to record cerebral oxygen saturation and continuous noninvasive or invasive arterial blood pressure measurement for 25-30 minutes. Cerebral oxygenation index (COx) is calculated as a moving Pearson correlation coefficient between mean arterial pressure and cerebral oxygen saturation over 30 consecutive 10-second epochs (300 seconds). COx ≥ 0.3 indicates impaired cerebral autoregulation, while COx < 0.3 indicates preserved autoregulation. Changes in cerebral oxygen saturation before and after carotid compression are also used to assess autoregulatory.
Carotid compression testProcedure or surgery
A carotid compression test is performed by compressing the common carotid artery at the lower one-third of the neck (avoiding the carotid sinus) against the transverse process of C6 until pulsation disappears for 5-10 seconds, followed by release. If the brain oxygen saturation has increased compared to before the test, it indicates that the brain's automatic blood flow regulation function is intact; conversely, if it has decreased, it is regarded as a damaged automatic blood flow regulation function of the brain.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Autoregulation Monitoring After Mechanical Thrombectomy | Experimental | Participants with acute intracranial large vessel occlusion in the anterior circulation who achieve successful recanalization (mTICI 2b-3) after mechanical thrombectomy will undergo bedside cerebral autoregulation monitoring. Monitoring includes continuous near-infrared spectroscopy (NIRS) to record cerebral oxygen saturation and continuous noninvasive or invasive blood pressure measurement for 25-30 minutes immediately after recanalization. A carotid compression test is performed to dynamically assess cerebral autoregulation. Receives: Device: NIRS-based cerebral oxygenation and blood pressure monitoring; Procedure: Carotid compression test |
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 (1)
Early neurological improvement
Early neurological 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 nstitutes of Health Stroke Scale zero to one 24 hours after thrombectomy.
Measured: 24±12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start31 Jul 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion5 Feb 2027 (estimated)
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 227 participants (estimated)
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
- NCT07747701
- Sponsor's protocol ID
- FACTOR
- Acronym
- FACTOR
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation Monitoring: a Multicenter, Prospective, Interventional Study
- ClinicalTrials.gov ID
- NCT07747701
- Acronym / sponsor ID
- FACTOR / FACTOR
- Conditions
- Acute Ischemic Stroke, Cerebral Autoregulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 227 participants (estimated)
- Lead sponsor
- Beijing Shijitan Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 5 Aug 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.
This multicenter, prospective, and interventional diagnostic accuracy study enrolls patients undergoing thrombectomy with intraoperative cerebral autoregulation monitoring and follows them up at predefined time points up to 90 days post-enrollment.This study aims to evaluate a monitoring system based on cerebral autoregulation function and explore its predictive value for adverse neurological outcomes at the ultra-early stage following mechanical thrombectomy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral Autoregulation Monitoring After Mechanical Thrombectomy | Experimental | Device: NIRS-based cerebral oxygenation and blood pressure monitoring, Procedure: Carotid compression testParticipants with acute intracranial large vessel occlusion in the anterior circulation who achieve successful recanalization (mTICI 2b-3) after mechanical thrombectomy will undergo bedside cerebral autoregulation monitoring. Monitoring includes continuous near-infrared spectroscopy (NIRS) to record cerebral oxygen saturation and continuous noninvasive or invasive blood pressure measurement for 25-30 minutes immediately after recanalization. A carotid compression test is performed to dynamically assess cerebral autoregulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18
- Diagnosis of acute ischemic stroke caused by anterior circulation large vessel occlusion (intracranial internal carotid artery or M1 segment of the middle cerebral artery).
- National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 at presentation.
- Pre-stroke modified Rankin Scale (mRS) score ≤ 1.
- Symptom onset ≤ 24 hours.
Key exclusion criteria (18 listed)
- Pre-procedural baseline imaging showing significant intracranial hemorrhagic transformation, intracranial arterial dissection, large chronic cerebral infarction, or intracranial metastasis from malignant tumors.
- Any degree of stenosis, plaque, dissection, severe tortuosity, or imaging evidence of unstable/vulnerable plaque in the target-side or bilateral common carotid artery or the origin of the internal carotid artery.
- Known history of carotid sinus hypersensitivity syndrome, severe autonomic dysfunction, sick sinus syndrome, high-grade atrioventricular conduction block, or other malignant arrhythmias.
- Refractory malignant hypertensive crisis (systolic blood pressure persistently ≥ 200 mmHg despite standardized intravenous antihypertensive therapy, or hemodynamic instability with shock).
- Known severe allergy to contrast agents or anesthetic drugs, or contraindications to antiplatelet/anticoagulation therapy.
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 |
|---|---|---|
| NIRS-based cerebral oxygenation and blood pressure monitoringBedside multimodal cerebral autoregulation monitoring performed immediately after successful mechanical thrombectomy (mTICI 2b-3). Monitoring includes continuous near-infrared spectroscopy (NIRS) to record cerebral oxygen saturation and continuous noninvasive or invasive arterial blood pressure measurement for 25-30 minutes. Cerebral oxygenation index (COx) is calculated as a moving Pearson correlation coefficient between mean arterial pressure and cerebral oxygen saturation over 30 consecutive 10-second epochs (300 seconds). COx ≥ 0.3 indicates impaired cerebral autoregulation, while COx < 0.3 indicates preserved autoregulation. Changes in cerebral oxygen saturation before and after carotid compression are also used to assess autoregulatory. | Device | Cerebral Autoregulation Monitoring After Mechanical Thrombectomy |
| Carotid compression testA carotid compression test is performed by compressing the common carotid artery at the lower one-third of the neck (avoiding the carotid sinus) against the transverse process of C6 until pulsation disappears for 5-10 seconds, followed by release. If the brain oxygen saturation has increased compared to before the test, it indicates that the brain's automatic blood flow regulation function is intact; conversely, if it has decreased, it is regarded as a damaged automatic blood flow regulation function of the brain. | Procedure or surgery | Cerebral Autoregulation Monitoring After Mechanical Thrombectomy |
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)]
1 secondary outcome
Early neurological improvement
Time frame: 24±12 hours
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 13 Oct 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.
Shen Li principal investigator
Beijing Shijitan Hospital, Capital Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRS-based cerebral oxygenation and blood pressure monitoring and Carotid compression test in people with Acute Ischemic Stroke and Cerebral Autoregulation, run by Beijing Shijitan Hospital, Capital Medical University at 4 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 8 inclusion and 18 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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 Simeng Wang (010-63925615, wsm990419@163.com), or a site near the patient. 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 13 Oct 2026.