Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation Monitoring (FACTOR)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke; Cerebral Autoregulation
• Intervention / Treatment: Device: NIRS-based cerebral oxygenation and blood pressure monitoring; Procedure: Carotid compression test

• Study Type: Interventional
• Enrollment (Estimated): 227
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shen Li; Phone Number: 010-63925616; Email: lishen@mail.ccmu.edu.cn
• Study Contact Backup: Name: Simeng Wang; Phone Number: 010-63925615; Email: wsm990419@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Shijitan Hospital, Capital Medical University
    • Principal Investigator: Shen Li
    • Contact: Shen Li; Phone Number: 010-63925616; Email: lishen@mail.ccmu.edu.cn
  • Dalian, China
    • Not yet recruiting
    • Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)
    • Contact: Xiaoyan Lan; Phone Number: +86 15840985380; Email: jinnerlan@hotmail.com
    • Principal Investigator: Xiaoyan Lan
  • Heilongjiang, China
    • Not yet recruiting
    • The First Affiliated Hospital of Harbin Medical University
    • Principal Investigator: Guang Zhang
    • Contact: Guang Zhang; Phone Number: +86 13945085063; Email: Zhangguang@hrbmu.edu.cn
  • Shandong, China
    • Recruiting
    • Weifang People's Hospital Affiliated to Weifang Medical University
    • Principal Investigator: Weili Li
    • Contact: Weili Li; Phone Number: +86 15169697295; Email: liweili0536@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18
2. Diagnosis of acute ischemic stroke caused by anterior circulation large vessel occlusion (intracranial internal carotid artery or M1 segment of the middle cerebral artery).
3. National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 at presentation.
4. Pre-stroke modified Rankin Scale (mRS) score ≤ 1.
5. Symptom onset ≤ 24 hours.
6. 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.
7. Underwent mechanical thrombectomy and achieved successful recanalization (mTICI 2b-3).
8. Patient or legally authorized representative provides written informed consent.

Exclusion Criteria:

1. Pre-procedural baseline imaging showing significant intracranial hemorrhagic transformation, intracranial arterial dissection, large chronic cerebral infarction, or intracranial metastasis from malignant tumors.
2. 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.
3. Known history of carotid sinus hypersensitivity syndrome, severe autonomic dysfunction, sick sinus syndrome, high-grade atrioventricular conduction block, or other malignant arrhythmias.
4. Refractory malignant hypertensive crisis (systolic blood pressure persistently ≥ 200 mmHg despite standardized intravenous antihypertensive therapy, or hemodynamic instability with shock).
5. Known severe allergy to contrast agents or anesthetic drugs, or contraindications to antiplatelet/anticoagulation therapy.
6. Severe systemic active infection, multiple organ failure, or expected survival < 6 months.
7. 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).
8. Blood glucose < 2.7 mmol/L or > 22.2 mmol/L.
9. Heart failure with NYHA class > II, or persistent systolic blood pressure < 100 mmHg.
10. Central nervous system infection or intracranial tumor.
11. Unstable vital signs.
12. Severe alcohol dependence or drug dependence.
13. Cognitive impairment or psychiatric disorders that may affect follow-up assessments.
14. Pregnant or breastfeeding women.
15. Participation in another clinical drug or device study within the past 30 days.
16. Local skin damage or other conditions preventing proper placement of monitoring electrodes.
17. Severe agitation or other conditions that interfere with data acquisition.
18. Any other condition judged by investigators to potentially affect study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cerebral Autoregulation Monitoring After Mechanical Thrombectomy; 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.

Device: NIRS-based cerebral oxygenation and blood pressure monitoring; 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.; Procedure: Carotid compression test; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of Modified Rankin scale	the distribution of Modified Rankin scale (mRS) [ranging from 0 (normal) to 6 (death)]	90±7days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24±12 hours

Collaborators and Investigators

• Sponsor: Beijing Shijitan Hospital, Capital Medical University
• Investigators: Principal Investigator: Shen Li, Beijing Shijitan Hospital, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 5, 2027

Study Registration Dates

• First Submitted: July 31, 2026
• First Submitted That Met QC Criteria: July 31, 2026
• First Posted (Actual): August 5, 2026

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 14, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Equipment and Supplies; Diagnostic Equipment; Sphygmomanometers; Blood Pressure Monitors
• Other Study ID Numbers: FACTOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No