Actively Recruiting

Age: 18Years +
All Genders
NCT07556068

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

Led by Beijing Shijitan Hospital, Capital Medical University · Updated on 2026-05-06

129

Participants Needed

4

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 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 65 6 obtained prior to endovascular treatment.
  • Modified Rankin Scale 64 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 65 3; for patients with symptom onset between 6 and 24 hours: age 64 80 years and ASPECTS 65 3.
  • Patient/Legally Authorized Representative has signed the Informed Consent Form.
Not Eligible

You will not qualify if you...

  • 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 �d7 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 64 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 bcmol/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.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 4 locations

1

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Actively Recruiting

2

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Actively Recruiting

3

Dalian Municipal Central Hospital

Dalian, Liaoning, China

Not Yet Recruiting

4

Weifang People's Hospital Affiliated to Weifang Medical University

Weifang, Shandong, China

Actively Recruiting

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Research Team

Z

Zidong Li

CONTACT

S

Shen Li

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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