Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06758609

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

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, China, 510317

Actively Recruiting

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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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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 | DecenTrialz