Status:
NOT_YET_RECRUITING
Endovascular Treatment for Stroke Post 1 Day （24 Hours）
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Acute ischemic stroke (AIS) is one of the leading causes of disability and mortality worldwide. The treatment of this condition is time-critical, with the key to effective therapy being the early reca...
Eligibility Criteria
Inclusion
- General Inclusion Criteria
- Age≥18 and ≤80
- Baseline NIHSS ≥ 6 and maintained ≥ 6 before randomization
- Stroke onset or more than 24 hours from the last known well state and within 30 days.
- Pre-stroke mRS score of 0 or 1 points
- The subject or their legally authorized representative has signed the informed consent form for the study
- Imaging Inclusion Criteria
- Magnetic Resonance Angiography (MRA), Computed Tomography Angiography (CTA), or Digital Subtraction Angiography (DSA) confirms the occlusion of major intracranial vessels (occlusion of the internal carotid artery and/or the middle cerebral artery M1/M2 segment)
- Meets one of the following imaging evaluation criteria:
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- Assessed by Computed Tomography Perfusion (CTP) or Perfusion Weighted Imaging (PWI) with MRI: Infarct core volume is less than 100 mL and the mismatch ratio is ≥1.2 or the mismatch volume is ≥10 mL.
- Clinical imaging mismatch is defined by MR-DWI or CTP-rCBF images as:
- Infarct volume is less than 30 mL and NIHSS score is ≥10;
- Infarct volume is between 30 mL and 100 mL and NIHSS score is ≥20
Exclusion
- General Exclusion Criteria
- In the judgment of the clinician responsible for treatment, it is considered unlikely to benefit from the trial (e.g., advanced dementia, severe pre-stroke disability (mRS ≥2), high likelihood of early death)
- Major comorbidities that may interfere with the assessment of results and follow-up (e.g., severe heart failure, renal failure, etc.)
- Rapid improvement in neurologic status to NIHSS\<6 or evidence of vascular reconstruction before randomization
- Uncontrolled seizures at the time of stroke onset that, if preventing the acquisition of an accurate baseline NIHSS
- Baseline platelet count\<50,000/uL
- Severe persistent hypertension (systolic blood pressure \>220 mmHg or diastolic blood pressure\>120 mmHg)
- Known hereditary or acquired bleeding diathesis, coagulation factor deficiency, or recent oral anticoagulant therapy with an International Normalized Ratio (INR) \>3
- Suspected septic emboli, suspected bacterial endocarditis
- Known allergy to iodine, heparin, anesthetics, or other clear contraindications to the endovascular treatment procedure
- Pregnant women
- Other serious, progressive, or terminal illnesses (as judged by the investigator) or life expectancy of less than 6 months
- Attempt to use a neurothrombectomy device to remove the blood clot before randomization
- Currently participating in other studies of investigational drugs or devices
- Any other conditions that, in the opinion of the investigator, would impede endovascular surgery or pose a significant risk to the subject during endovascular surgery
- Imaging Exclusion Criteria
- Intracranial hemorrhage, including parenchymal hemorrhage, ventricular hemorrhage, subarachnoid hemorrhage, and epidural/subdural hemorrhage;
- Evidence of intracranial tumors as shown by CT or MRI (except for small meningiomas);
- CTA/MRA showing excessive tortuosity of the cervical vessels, which may hinder endovascular treatment;
- Suspected aortic dissection based on medical history and CTA/MRA;
- Presence of an intracranial stent in the same vascular area, which would impede the smooth progress of surgery.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT06580730
Start Date
September 1 2024
End Date
August 1 2026
Last Update
September 5 2024
Active Locations (1)
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1
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China