Actively Recruiting
Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke
Led by Beijing Shijitan Hospital, Capital Medical University · Updated on 2025-04-04
258
Participants Needed
9
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 combined with endovascular therapy in the treatment of acute anterior circulation large vessel occlusion stroke. This trial aims to enroll 258 subjects. Patients assigned to the control group will receive best medical management (BMM) and endovascular therapy (EVT). Those in the selective intra-arterial cooling infusion group (IA-SCI group) will undergo selective intra-arterial cold saline infusion, in addition to BMM and EVT. Subjects will be interviewed face-to-face at randomization, 24±6 hours, 48±6 hours after randomization, 7±2 days/discharge. Telephone interviews/ face-to face interviews will be performed at 30±3 days and 90±7 days after randomization. The primary outcome is the distribution of Modified Rankin Score at 90±7days after randomization.
CONDITIONS
Official Title
Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Clinical signs of acute ischemic stroke with large vessel occlusion in anterior circulation confirmed by imaging
- NIH Stroke Scale score between 6 and 25 before randomization
- Modified Rankin Scale score of 0 or 1 before the qualifying stroke
- Arterial puncture within 24 hours from symptom onset or last known well time
- ASPECT score of 6 or higher for symptoms within 6 hours; or meet DAWN or DEFUSE-3 imaging criteria for onset 6-24 hours
- Signed informed consent by patient or legal representative
You will not qualify if you...
- Multiple acute strokes in different vascular territories confirmed by imaging
- Arterial dissection confirmed by imaging
- Intracranial hemorrhage or hemorrhagic transformation before thrombectomy
- Known allergies or intolerances to antiplatelet, anticoagulant drugs, iodinated contrast, or anesthetics
- Severe infection or multiple organ failure
- Known bleeding disorders or recent anticoagulant therapy with high INR
- Platelet count below 50 x 10^9/L
- Blood glucose below 50 mg/dL or above 400 mg/dL
- Uncontrolled high blood pressure (systolic >185 mmHg or diastolic >110 mmHg)
- Previous New York Heart Association class greater than 1
- Untreated moderate or severe coronary artery disease or previous bypass surgery
- Undergoing dialysis or severe kidney insufficiency
- Known brain aneurysm or arteriovenous malformation
- Malignant brain tumor or central nervous system infection
- Pre-existing neurological or psychiatric conditions affecting evaluations
- Pregnant or lactating females at admission
- Life expectancy less than 6 months
- Current participation in other investigational drug or device studies
- Any other reason clinicians deem the patient unsuitable for treatment
AI-Screening
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Trial Site Locations
Total: 9 locations
1
The Second Hospital and Clinical Medical School, Lanzhou University
Lanzhou, Gansu, China
Actively Recruiting
2
Department of Neurosurgery, Nanshi Hospital of Nanyang
Nanyang, Henan, China
Actively Recruiting
3
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
4
Beijing Shijitan Hospital, Capital Medical University
Beijing, China
Actively Recruiting
5
Peking University Internation Hospital
Beijing, China
Actively Recruiting
6
967 Hospital of the Joint Logistics Support Force of PLA
Dalian, China
Actively Recruiting
7
Dalian Municipal Central Hospital
Dalian, China
Actively Recruiting
8
The First Affiliated Hospital of Harbin Medical University
Ha’erbin, China
Actively Recruiting
9
Affiliated Hospital of Inner Mongolia University for the Nationalities
Tongliao, China
Actively Recruiting
Research Team
R
Ruiwen Che
CONTACT
S
Shen Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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