Actively Recruiting
To Assess the Effectiveness and Safety of Catheter-based Focal Intracranial Hypothermia Combined with Endovascular Reperfusion Therapy for Patients with Acute Anterior Circulation Large Artery Occlusion
Led by Guangdong Second Provincial General Hospital · Updated on 2025-01-06
262
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial to assess the effectiveness and safety of catheter-based focal intracranial hypothermia combined with endovascular reperfusion therapy for patients with acute anterior circulation large artery occlusion.
CONDITIONS
Official Title
To Assess the Effectiveness and Safety of Catheter-based Focal Intracranial Hypothermia Combined with Endovascular Reperfusion Therapy for Patients with Acute Anterior Circulation Large Artery Occlusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years old
- Sudden onset of focal or general neurological impairment
- Possible link between artery blockage and neurological symptoms
- Time from symptom onset to randomization is 24 hours or less
- NIH Stroke Scale score of 6 points or higher before randomization
- Clinician judges that the operation path and instruments are suitable
- Participant or guardian can understand the trial purpose, consent, and follow-up
- Imaging confirms large vessel occlusion in anterior circulation (internal carotid artery or M1 segment)
- Symptoms worsen due to recurrent infarction or decreased blood flow in the affected area
You will not qualify if you...
- Pre-stroke modified Rankin Score greater than 1
- Acute infarcts in both brain hemispheres or both anterior and posterior circulation
- NIH Stroke Scale score less than 6 points
- Cerebral or subarachnoid hemorrhage confirmed by CT or MRI
- Active bleeding, severe anemia, coagulation issues, or uncorrected bleeding tendency
- Heart function grade 1 or above, or history of acute or chronic heart dysfunction increasing risk
- Severe heart, liver, or kidney disease
- Malignant disease with expected survival less than 3 months
- Participation in other clinical trials in investigational or follow-up phase
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China, 510317
Actively Recruiting
Research Team
Z
Zhixin Huang, PhD
CONTACT
W
Wen Sun, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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