Trials / Recruiting
RecruitingNCT06758609
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
Local Hypothermia and Endovascular Recanalization for Acute Large Artery Occlusive Stroke-A Multicenter, Prospective, Open-label, Blinded-Endpoint, Randomized Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 262 (estimated)
- Sponsor
- Guangdong Second Provincial General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This trial aims 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. This study used a stratified randomization method, with participants randomly allocated in a 1:1 ratio by a central network randomization system to either the mechanical thrombectomy (MT) combined with arterial selective cooling infusion (intravenous recombinant tissue plasminogen activator) (hypothermia) group or the MT combined with normal saline infusion (normothermia) group (hereinafter referred to as the hypothermia group or normothermia group). Randomization was stratified by ASPECTS score (≥8 or \<8) and age (≥75 years or \<75 years).
Conditions
- Acute Cerebrovascular Accident
- Acute Ischemic Stroke
- Internal Carotid Artery
- Middle Cerebral Artery Occlusion
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2024-12-01
- Primary completion
- 2026-03-30
- Completion
- 2026-06-30
- First posted
- 2025-01-06
- Last updated
- 2025-01-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06758609. Inclusion in this directory is not an endorsement.