Rescue Endovascular Therapy for Progressive Acute Mild Ischemic Stroke With Large Vascular Occlusion

Launched by FIRST AFFILIATED HOSPITAL OF WANNAN MEDICAL COLLEGE · Nov 24, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether adding a treatment called endovascular therapy (EVT) to the best medical management can help patients who have experienced a minor stroke with a specific type of blockage in their blood vessels. The researchers want to find out if this combination is safer and more effective for patients who have had their symptoms get worse after the initial stroke, especially if it has been over 24 hours since their stroke began. This is important because sometimes patients with minor strokes can still have serious issues if their condition worsens, and it’s unclear whether they can benefit from EVT in this situation.

To be eligible for the trial, participants must be at least 18 years old and have specific symptoms of an acute ischemic stroke, with a score indicating their condition (the NIHSS score) below 6 initially, but worsening to 6 or higher before being enrolled. They also need to have evidence of a blockage in a major brain artery confirmed by imaging tests. People with certain health issues or recent serious medical events, like severe bleeding or major surgeries, may not qualify. If someone participates, they can expect to receive either EVT combined with standard care or just standard care alone, and will be closely monitored throughout the study.

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Eligibility criteria

• Inclusion Criteria:
• • General Inclusion Criteria：
• • Age ≥ 18 years；
• • Presenting with symptoms consistent with an AIS and the initial NIHSS score \<6 points；
• • Symptom progression within 7 days of first onset；
• • Randomization can be finished \> 24 hours of stroke onset (stroke onset time is defined as last known well time)；
• • Symptom progression to randomization time ≤ 24 hours；
• • NIHSS score before randomization ≥ 6 points；
• • Informed consent signed.
• • Specific Neuroimaging Inclusion Criteria
• • CTA or MRA proved occlusion of Internal Carotid Artery (ICA) terminal or M1 segment of Middle Cerebral Artery;
• • The progression of symptoms is caused by the recurrence of cerebrovascular diseases in the same vascular region, or the pathogenesis is caused by reduced blood flow perfusion;
• • NCCT ASPECTS before randomization ≥ 6
• • CTP or MRP assessment shows low perfusion in the target vessel area, and meets the following criteria: core infarction volume is less than 50ml, mismatch rate is greater than or equal to 1.8, and mismatch volume is greater than 15ml.
• Exclusion Criteria:
• • Pre-stroke mRS score \>1;
• • Imaging confirms the progression of symptoms caused by intracranial hemorrhage, brain edema, or other clear causes;
• • The target vessel may have factors that may prevent it from completing endovascular treatment, such as a diameter less than 1.5mm, a tortuous vascular pathway, difficulty in reaching the target position with instruments, or difficulty in recovery;
• • Severe stenosis or occlusion of multiple blood vessels;
• • Combined with untreated intracranial aneurysms, intracranial tumors (excluding small meningiomas), or intracranial vascular malformations;
• • Intracranial hemorrhage within 6 months, including cerebral parenchymal hemorrhage, ventricular hemorrhage, and subarachnoid hemorrhage;
• • Have had gastrointestinal or urinary system bleeding, acute myocardial infarction, traumatic brain injury, or undergone major surgical procedures within the past month;
• • Known hemorrhagic tendency (including but not limited to): Baseline platelet count \<40×109/L; on anticoagulant therapy with warfarin and International Normalized Ratio (INR) \> 2 (Patients with no history or suspected coagulopathy do not need to wait for laboratory results of INR or APTT prior to enrollment) Severe heart, liver, kidney function damage or other severe late stage diseases of the system;
• • Known allergies to treatment related drugs such as iodine contrast agents, etc; Known severe allergy (more than a rash) to contrast media uncontrolled by medications;
• • Refractory hypertension (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg);
• • Uncontrolled blood sugar abnormalities (less than 2.8mmol/l or greater than 22.2mmol/l);
• • Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test;
• • The expected survival time is less than 1 year (such as complicated with malignant tumor, serious heart and lung diseases, etc.)
• • Participation in other interventional randomized clinical trials that may confound outcome assessment of the trial
• • Other circumstances that the investigator considers inappropriate for participation in the trial or that may pose significant risks to patients (such as inability to understand and/or follow the study procedures and/or follow up due to mental disorders, cognitive or emotional disorders)