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
NCT06758609 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 262
Last updated 2025-01-06
Summary
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
- Acute Cerebrovascular Accident
- Acute Ischemic Stroke
- Internal Carotid Artery
- Middle Cerebral Artery Occlusion
Interventions
- PROCEDURE
-
Mechanical thrombectomy
Mechanical thrombectomy
- DRUG
-
4°C saline infusion
Patients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT).
- DRUG
-
Normothermic saline infusion
Patients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT).
Sponsors & Collaborators
-
Guangdong Second Provincial General Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-01
- Primary Completion
- 2026-03-30
- Completion
- 2026-06-30
Countries
- China
Study Locations
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