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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06758609 on ClinicalTrials.gov