Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke

NCT06485427 | Completed DMC

• 1 other identifier: FOCUS
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 12

Brief Summary

This is a multicenter, randomized, controlled, subject- and assessor-blinded clinical trial. The research objective is to evaluate the safety and efficacy of selective intra-arterial cooling infusion combined with endovascular therapy in the treatment of acute anterior circulation large vessel occlusion stroke. This trial aims to enroll 258 subjects. Patients assigned to the control group will receive best medical management (BMM) and endovascular therapy (EVT). Those in the selective intra-arterial cooling infusion group (IA-SCI group) will undergo selective intra-arterial cold saline infusion, in addition to BMM and EVT. Subjects will be interviewed face-to-face at randomization, 24±6 hours, 48±6 hours after randomization, 7±2 days/discharge. Telephone interviews/ face-to face interviews will be performed at 30±3 days and 90±7 days after randomization. The primary outcome is the distribution of Modified Rankin Score at 90±7days after randomization.

Conditions

Acute Ischemic Stroke; Hypothermia

Outcome Measures

Primary Outcomes (1)

• Distribution of Modified Rankin scale

  the distribution of Modified Rankin scale (mRS) \[ranging from 0 (normal) to 6 (death)\]

  90 ±7days

Secondary Outcomes (21)

• Percentage of functional independence (mRS scale 0-2)

  90 ±7days

• Percentage of favorable outcome (mRS scale 0-1)

  90 ±7days

• Final infarction volume

  7±2 days/discharge

• The changes of infarction volume

  7±2 days/discharge

• National Institute of Health stroke scale (NIHSS) score

  7±2 days/discharge

Study Arms (2)

Control group

NO INTERVENTION

Subjects will receive best medical management (BMM) plus endovascular therapy (EVT) according to the clinical guidelines.

IA-SCI group

EXPERIMENTAL

Subjects randomized to the IA-SCI group will receive selective intra-arterial cooling infusion plus BMM and EVT.

Procedure: Selective Intra-arterial Cooling Infusion (IA-SCI)

Interventions

Selective Intra-arterial Cooling Infusion (IA-SCI) PROCEDURE

Pre-recanalization: During the procedure, the micro-catheter is advanced over a micro-guide wire, traveling up through the neck until it reaches beyond the clot. A 50 mL cold 0.9% saline (4 ℃) is infused intro into the ischemic territory at a rate of 10 mL/min via the micro-catheter. This enables the cold solution to infuse into the ischemic territory prior to revascularization. Post-recanalization: After recanalization, cold 0.9% saline (4 ℃) is reinfused into the vessel via the catheter at a rate of 22 mL/min for 10 min, repeated twice with a 10-minute interval between infusions.

IA-SCI group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and ≤80.
• Clinical signs consistent with AIS-LVO in the anterior circulation (intracranial segment of internal carotid artery, M1 segment of middle cerebral artery (MCA) demonstrated by computed tomography angiography (CTA) / magnetic resonance angiography (MRA)/ digital subtraction angiography (DSA)).
• National Institutes of Health Stroke Scale (NIHSS) score (at screening) ≥6 and ≤25.
• Modified Rankin Scale (mRS) score ≤1 before stroke onset.
• Arterial puncture performed within 24 hours of symptom onset or last known well (LKW).
• Written informed consent obtained from the patients or legally authorized representatives.
• For patients admitted to the hospital within 6 hours of symptom onset, an Alberta Stroke Program Early CT Score (ASPECTS) ≥6 is required. For those admitted between 6 and 24 hours, the neuroimaging criteria of the DAWN or DEFUSE-3 trials are applied.

You may not qualify if:

• Baseline CT/MRI reveals the presence of acute infarction in multiple vascular territories.
• CTA/MRA/DSA confirms the presence of arterial dissection.
• Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
• Known allergies or intolerances to antiplatelet agents, anticoagulants, iodinated contrast, or anesthetics.
• Severe infection (e.g., sepsis) or multiple organ failure.
• Known hereditary or acquired hemorrhagic diathesis; coagulation factor deficiency; recent oral anticoagulant therapy with international normalized ratio (INR)\>3.
• Exception: Time elapsed since the last use of a novel oral anticoagulant ≥48 hours plus a normal activated partial thromboplastin time (APTT).
• Baseline platelet count \<50 × 109/L.
• Blood glucose concentration \<50 mg/dL (2.7 mmol/L) or \>400 mg/dL (22.2 mmol/L).
• Refractory hypertension that is difficult to control by medication (persistent systolic blood pressure (BP) \>185 mmHg or diastolic BP \>110 mmHg).
• Previous New York Heart Association (NYHA) functional classification \>I.
• Coronary artery stenosis \>70% or history of coronary artery bypass grafting.
• Undergoing hemodialysis or peritoneal dialysis; severe renal insufficiency with a glomerular filtration rate \<30 mL/min or serum creatinine \>220 mmol/L (2.5 mg/dL).
• Known intracranial aneurysm or cerebral arteriovenous malformation.
• Malignant brain tumor or central nervous system infection.

Sponsors & Collaborators

• Beijing Shijitan Hospital, Capital Medical University: lead

Study Sites (12)

The Second Hospital and Clinical Medical School, Lanzhou University

Lanzhou, Gansu, China

Location

Department of Neurosurgery, Nanshi Hospital of Nanyang

Nanyang, Henan, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China

Location

Beijing Shijitan Hospital, Capital Medical University

Beijing, China

Location

Peking University Internation Hospital

Beijing, China

Location

967 Hospital of the Joint Logistics Support Force of PLA

Dalian, China

Location

Dalian Municipal Central Hospital

Dalian, China

Location

Gansu Province Central Hospital

Gansu, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

The First Affiliated Hospital of Harbin Medical University

Ha’erbin, China

Location

Affiliated Hospital of Inner Mongolia University for the Nationalities

Tongliao, China

Location

MeSH Terms

Conditions

Ischemic Stroke; Hypothermia

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shen Li

  Beijing Shijitan Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 22, 2024
• First Posted: July 3, 2024
• Study Start: July 3, 2024
• Primary Completion: February 8, 2026
• Study Completion: March 1, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)