Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke

Launched by BEIJING SHIJITAN HOSPITAL, CAPITAL MEDICAL UNIVERSITY · Jun 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients who have experienced an acute ischemic stroke, which occurs when blood flow to part of the brain is blocked. Specifically, the researchers want to see if using a method called selective intra-arterial cooling infusion (which involves infusing cold saline directly into the blood vessels) along with standard treatments can help improve outcomes for patients with a specific type of stroke involving large blood vessel blockages. The trial plans to enroll 258 participants, and those who qualify will either receive the standard care or the new cooling treatment in addition to that care.

To be eligible for this trial, participants must be adults between 18 and 80 years old, have clear signs of a stroke with a blockage in certain brain arteries, and have a specific level of stroke severity. Patients will be closely monitored and interviewed at different times during their treatment and recovery to assess how well they are doing. It’s important to note that there are specific health conditions that might prevent someone from participating, such as certain types of severe infections, bleeding disorders, or previous serious heart conditions. If you or a loved one is considering joining this study, you would be informed about all these details and would need to sign a consent form to participate.

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Eligibility criteria

• • Inclusion Criteria
• • 1. Age ≥ 18 and ≤ 80.
• • 2. 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.
• • 3. NIHSS score obtained prior to randomization ≥ 6 and ≤ 25.
• • 4. Modified Rankin Scale ≤ 1 prior to qualifying stroke.
• • 5. Arterial puncture performed within 24 hours from symptom onset or LKW.
• • 6. For the patients with symptom onset within 6 hours, the ASPECT score ≥ 6; for the patients with onset within 6-24 hours, the therapy should meet the imaging criteria of DAWN or DEFUSE-3 trial.
• • 7. Patient/Legally Authorized Representative has signed the Informed Consent Form.
• • Exclusion Criteria
• • 1. Baseline CT/MRI confirms the presence of multiple vascular territory acute strokes.
• • 2. Baseline CT/MRI confirms the presence of arterial dissection.
• • 3. Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
• • 4. Known allergies or intolerances to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics.
• • 5. Severe infection (e.g. sepsis) or multiple organ failure.
• • 6. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR \> 3. Patients on factor Xa inhibitor for 48 hours ago must have a normal APTT.
• • 7. Baseline platelet count \< 50 × 10\^9/L.
• • 8. Blood glucose concentration\<50 mg/dL (2.7 mmol/L) or \>400 mg/dL (22.2 mmol/L).
• • 9. Refractory hypertension that is difficult to control by medication (Defined as persistent systolic blood pressure\>185 mmHg or diastolic blood pressure\>110 mmHg).
• • 10. Previous NHYA\>1.
• • 11. Untreated moderate or severe coronary artery stenosis, or previous coronary artery bypass surgery.
• • 12. Undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency with glomerular filtration rate \< 30 mL/min or serum creatinine \>220 mmol/L (2.5 mg/dL).
• • 13. Known intracranial aneurysm, and cerebral arteriovenous malformation.
• • 14. Malignant brain tumor or CNS infection.
• • 15. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g., dementia or mental illness)
• • 16. Female who is pregnant or lactating at time of admission.
• • 17. Anticipated life expectancy \< 6 months.
• • 18. Current participation in another investigational drug or device study.
• • 19. For other reasons, the responsible clinicians believe that the patient is not suitable for continued treatment.