Status:
NOT_YET_RECRUITING
Role of Hypothermia in Endovascular Stroke Thrombectomy
Lead Sponsor:
Xinqiao Hospital of Chongqing
Collaborating Sponsors:
Xiangtan Central Hospital
Conditions:
Stroke, Acute Ischemic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Reducing or suspending the increase of the infarcted core, i.e., "freezing" the ischemic penumbra, may help improve the efficacy of mechanical thrombectomy. Hypothermia effectively reduces the metabol...
Eligibility Criteria
Inclusion
- Aged ≥ 18 years or more;
- acute ischemic stroke within 24 hours from onset to randomization;
- NIHSS ≥6 points before randomization;
- Internal carotid artery, or the middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA/DSA;
- Baseline ASPECTS score ≥ 3 and ≤8, or cerebral infarction core volume \< 100ml;
- The patient decides to undergo endovascular therapy;
- The patient or patient's representative signs a written informed consent form.
Exclusion
- CT or MR evidence of hemorrhage;
- Currently pregnant or lactating (women patients);
- Allergy to radiographic contrast agents, or nitinol devices;
- Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
- Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation);
- Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
- Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;
- Brain tumors with mass effect (except meningiomas) that are radiographically pleasant;
- Intracranial aneurysm, arteriovenous malformation;
- Any terminal illness with life expectancy less than 6 months;
- Participating in other clinical trials.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06109376
Start Date
December 1 2023
End Date
March 31 2027
Last Update
October 31 2023
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