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

Recruiting now

Conditions studied: Acute Ischemic Stroke, Cerebral Autoregulation

In brief

This multicenter, prospective, observational 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. The study aims to determine whether impaired cerebral autoregulation during thrombectomy can serve as an ultra-early biomarker for predicting futile recanalization in patients with acute ischemic stroke.

Key facts

Study ID

NCT07556068

Run by

Beijing Shijitan Hospital, Capital Medical University

People needed

129

Starts

2026-04-20

Expected to finish

2026-10-20

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18
• Clinical signs consistent with acute ischemic stroke with large vessel occlusion in the anterior circulation (intracranial segment of the internal carotid artery, middle cerebral artery M1 segment) demonstrated with CTA/MRA/DSA.
• NIHSS score ≥ 6 obtained prior to endovascular treatment.
• Modified Rankin Scale ≤ 1 prior to qualifying stroke.
• Acute ischemic stroke, undergone endovascular treatment within 24 hours of onset (time of stroke is the last known normal for wake-up stroke or with unknown onset time).with reaching the goal of mTICI grade 2b-3
• For patients with symptom onset within 6 hours: ASPECTS ≥ 3; for patients with symptom onset between 6 and 24 hours: age ≤ 80 years and ASPECTS ≥ 3.
• Patient/Legally Authorized Representative has signed the Informed Consent Form.

You may not qualify if…

• Baseline CT/MRI confirms the presence of multiple vascular territory acute strokes.
• Baseline CT/MRI confirms the presence of arterial dissection.
• Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
• Known allergies or intolerances to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics.
• Severe infection (e.g. sepsis) or multiple organ failure.
• Known hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency; oral anticoagulant therapy with INR > 3; or use of a factor Xa inhibitor within the preceding 48 hours with an abnormal aPTT.
• Baseline platelet count < 50 × 10\^9/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 (Defined as persistent systolic blood pressure>185 mmHg or diastolic blood pressure>110 mmHg).
• Severe cardiomyopathy with heart failure (LVEF ≤ 30% or NYHA class IV), acute myocardial infarction, or unstable angina.
• Untreated moderate or severe coronary artery stenosis, or previous coronary artery bypass surgery.
• Current hemodialysis or peritoneal dialysis; known severe renal insufficiency with estimated glomerular filtration rate < 30 mL/min or serum creatinine > 220 μmol/L (2.5 mg/dL).
• Known intracranial aneurysm, and cerebral arteriovenous malformation.
• Malignant brain tumor or CNS infection.
• Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g., dementia or mental illness)
• Female who is pregnant or lactating at time of admission.
• Anticipated life expectancy < 6 months.
• Current participation in another investigational drug or device study.
• local skin damage or other conditions that cannot cooperate with electrode sticking.
• severe agitation or other conditions affecting data collection.

Where it is running

• Beijing Shijitan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (enrolling)
• Weifang People's Hospital Affiliated to Weifang Medical University — Weifang, Shandong, China (enrolling)
• Dalian Municipal Central Hospital — Dalian, Liaoning, China

Full record on ClinicalTrials.gov

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