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NCT07896655
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Conditions: Acute Ischemic Stroke, Basilar Artery Occlusion
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 818
Sponsor: Guangdong Second Provincial General Hospital
Location: The First Affiliated Hospital of University of Science and Technology of China Hefei Anhui
Summary
This study will examine whether cooling part of the brain through a catheter after endovascular treatment improves recovery in adults with acute basilar artery occlusion, a type of severe stroke. After blood flow has been successfully restored, 818 participants will be randomly assigned to receive either cold saline or room-temperature saline through an artery. The main outcome is the level of disability 90 days later, measured using the modified Rankin Scale. The study will also assess safety, including bleeding in the brain and other complications.
Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years;
2. Sudden onset of focal or global neurological deficit symptoms;
3. Emergency imaging (CTA, MRA, or DSA) prior to randomization confirms occlusion of the basilar artery or vertebral artery. In the case of vertebral artery occlusion, bidirectional blood flow to the basilar artery must be completely obstructed, accompanied by corresponding neurological deficit symptoms;
4. EVT is initiated within 24 hours of symptom onset;
5. The National Institutes of Health Stroke Scale (NIHSS) score is ≥10 before the start of the procedure;
6. Pc-ASPECTS ≥3;
7. Pre-stroke mRS score of 0-1;
8. Randomization Trigger Conditions:
(1)Successful recanalization of the basilar artery after endovascular treatment; (2)Definition of successful recanalization: eTICI grade reaching 2b, 2c,or 3; 9.The patient or their legal guardian is able to understand the purpose of the trial, voluntarily participate and sign a written informed consent form, and is capable of undergoing clinical follow-up.
Exclusion Criteria:
1. Hypothermia-specific contraindications: (1)Hypothermia: Baseline core body temperature (rectal) \
Source: ClinicalTrials.gov (NCT07896655). StuddyBuddy aggregates publicly available trial information.