Status:
RECRUITING
Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke
Lead Sponsor:
Beijing Shijitan Hospital, Capital Medical University
Conditions:
Acute Ischemic Stroke
Hypothermia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is a multicenter, randomized, controlled, subject- and assessor-blinded clinical trial. The research objective is to evaluate the safety and efficacy of selective intra-arterial cooling infusion ...
Detailed Description
Acute ischemic stroke (AIS) is the leading cause of death and disability in China. Randomized trials involving patients with acute stroke due to large-artery occlusion in the anterior circulation have...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age ≥ 18 and ≤ 80.
- 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.
- NIHSS score obtained prior to randomization ≥ 6 and ≤ 25.
- Modified Rankin Scale ≤ 1 prior to qualifying stroke.
- Arterial puncture performed within 24 hours from symptom onset or LKW.
- 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.
- Patient/Legally Authorized Representative has signed the Informed Consent Form.
- Exclusion Criteria
- Baseline CT/MRI confirms the presence of multiple vascular territory acute strokes.
- Baseline CT/MRI confirms the presence of arterial dissection.
- Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
- Known allergies or intolerances to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics.
- Severe infection (e.g. sepsis) or multiple organ failure.
- 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.
- Baseline platelet count \< 50 × 10\^9/L.
- Blood glucose concentration\<50 mg/dL (2.7 mmol/L) or \>400 mg/dL (22.2 mmol/L).
- Refractory hypertension that is difficult to control by medication (Defined as persistent systolic blood pressure\>185 mmHg or diastolic blood pressure\>110 mmHg).
- Previous NHYA\>1.
- Untreated moderate or severe coronary artery stenosis, or previous coronary artery bypass surgery.
- 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).
- Known intracranial aneurysm, and cerebral arteriovenous malformation.
- Malignant brain tumor or CNS infection.
- Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g., dementia or mental illness)
- Female who is pregnant or lactating at time of admission.
- Anticipated life expectancy \< 6 months.
- Current participation in another investigational drug or device study.
- For other reasons, the responsible clinicians believe that the patient is not suitable for continued treatment.
Exclusion
Key Trial Info
Start Date :
July 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT06485427
Start Date
July 3 2024
End Date
August 1 2026
Last Update
April 4 2025
Active Locations (9)
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1
The Second Hospital and Clinical Medical School, Lanzhou University
Lanzhou, Gansu, China
2
Department of Neurosurgery, Nanshi Hospital of Nanyang
Nanyang, Henan, China
3
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
4
Beijing Shijitan Hospital, Capital Medical University
Beijing, China