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 | Recruiting

• 1 other identifier: CHILL-ART
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with modified Rankin Score 0-2 at 90 days.

  The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.

  90 days after procedure

Secondary Outcomes (5)

• Proportion of patients with modified Rankin Score 0-1 at 90 days

  90 days after procedure

• Successful reperfusion rate

  At the end of the operation

• Cerebral infarction volume was measured by CT or magnetic resonance DWI 72 hours to 7 days after operation

  72 hours to 7 days after procedure

• Incidence of early neurological deterioration

  Within 24 hours after procedure

• Rate of recurrent occlusion on MRA or CTA (postoperative 24 Hours to 7 Days)

  postoperative 24 Hours to 7 Days

Other Outcomes (2)

• Rate of symptomatic intracranial hemorrhage within 72 hours (Heidelberg Bleeding Classification)

  Within 72 hours after procedure

• Rate of coagulation disorders

  7 days

Study Arms (2)

Mechanical thrombectomy combined with intra-arterial selective cooling infusion (hypothermia) group

EXPERIMENTAL

Patients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT).

Procedure: Mechanical thrombectomy; Drug: 4°C saline infusion

Mechanical thrombectomy combined with normothermic saline infusion (normothermia) group

ACTIVE COMPARATOR

Patients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT).

Procedure: Mechanical thrombectomy; Drug: Normothermic saline infusion

Interventions

Mechanical thrombectomy PROCEDURE

Mechanical thrombectomy

Mechanical thrombectomy combined with intra-arterial selective cooling infusion (hypothermia) group; Mechanical thrombectomy combined with normothermic saline infusion (normothermia) group

4°C saline infusion DRUG

Patients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT).

Mechanical thrombectomy combined with intra-arterial selective cooling infusion (hypothermia) group

Normothermic saline infusion DRUG

Patients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT).

Mechanical thrombectomy combined with normothermic saline infusion (normothermia) group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and ≤85 years old.
• Symptoms of sudden focal or general neurological impairment.
• There may be a causal relationship between vascular occlusion and nerve function defect.
• Time from symptom onset to randomization ≤24h.
• The National Institutes of Health Stroke Scale (NIHSS) score was ≥6 points before randomization.
• According to the judgment of the clinician, the operation path is reasonable, and the operation and operation related instruments can reach the disease smoothly.
• Patients or their guardians can understand the purpose of the trial, voluntarily participate and sign a written informed consent, and are capable of receiving clinical follow-up.
• Prior to randomization, CTA, MRA, or DSA confirmed the presence of anterior circulatory large vessel occlusion (internal carotid artery or M1segment).
• The symptoms are aggravated by recurrent cerebral infarction in the same drainage basin and/or the pathogenesis is caused by decreased blood perfusion.

You may not qualify if:

• Pre stroke mRS\>1 score.
• There are acute infarcts in both cerebral hemispheres and/or anterior and posterior circulation.
• NIHSS≤6 points.
• Cerebral hemorrhage/subarachnoid hemorrhage was confirmed by CT or MRI. 5.The presence of active bleeding, severe anemia, coagulation dysfunction, or an uncorrected bleeding tendency (Presence of at least one of the following laboratory tests: hemoglobin \< 10g /dl, platelet count \< 100,000 /μl, uncorrected INR\>1.5, PT\> 1 minute above the upper limit of normal, or heparin-related thrombocytopenia).
• Patients with heart function of grade 1 or above, or with a clear history of acute or chronic heart dysfunction, are at greater risk of acute heart failure or fluid perfusion intolerance as determined by clinicians.
• \. Severe heart, liver, kidney disease. 8.With malignant diseases such as malignant tumors, the expected survival time is less than 3 months.
• Participating in other clinical trials, in the investigational phase or in the follow-up phase.

Sponsors & Collaborators

• Guangdong Second Provincial General Hospital: lead

Study Sites (1)

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, 510317, China

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Infarction, Middle Cerebral Artery

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Zhixin Huang, PhD

CONTACT

8613607548156; hzxd6@163.com

Wen Sun, PhD

CONTACT

8615050589620; sunwen_medneuro@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 6, 2025
• Study Start: December 1, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 6, 2025

Record last verified: 2024-12

Locations

CN (1)