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

NCT06485427 | Recruiting DMC

• 1 other identifier: FOCUS
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 9

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 acute ischemic stroke with large vessel occlusion in the anterior circulation (intracranial segment of the internal carotid artery, middle cerebral artery M1 segment) demonstrated with CTA/MRA/DSA.
• NIHSS score obtained prior to randomization ≥ 6 and ≤ 25.
• Modified Rankin Scale ≤ 1 prior to qualifying stroke.
• Arterial puncture performed within 24 hours from symptom onset or LKW.
• For the patients with symptom onset within 6 hours, the ASPECT score ≥ 6; for the patients with onset within 6-24 hours, the therapy should meet the imaging criteria of DAWN or DEFUSE-3 trial.
• Patient/Legally Authorized Representative has signed the Informed Consent Form.

You may not qualify if:

• Baseline CT/MRI confirms the presence of multiple vascular territory acute strokes.
• Baseline CT/MRI confirms the presence of arterial dissection.
• Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
• Known allergies or intolerances to antiplatelet agents, anticoagulation drugs, iodinated contrast and/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 INR \> 3. Patients on factor Xa inhibitor for 48 hours ago must have a normal APTT.
• Baseline platelet count \< 50 × 10\^9/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 (Defined as persistent systolic blood pressure\>185 mmHg or diastolic blood pressure\>110 mmHg).
• Previous NHYA\>1.
• Untreated moderate or severe coronary artery stenosis, or previous coronary artery bypass surgery.
• Undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency with glomerular filtration rate \< 30 mL/min or serum creatinine \>220 mmol/L (2.5 mg/dL).
• Known intracranial aneurysm, and cerebral arteriovenous malformation.
• Malignant brain tumor or CNS infection.
• Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g., dementia or mental illness)

Sponsors & Collaborators

• Beijing Shijitan Hospital, Capital Medical University: lead

Study Sites (9)

The Second Hospital and Clinical Medical School, Lanzhou University

Lanzhou, Gansu, China

RECRUITING

Department of Neurosurgery, Nanshi Hospital of Nanyang

Nanyang, Henan, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

Beijing Shijitan Hospital, Capital Medical University

Beijing, China

RECRUITING

Peking University Internation Hospital

Beijing, China

RECRUITING

967 Hospital of the Joint Logistics Support Force of PLA

Dalian, China

RECRUITING

Dalian Municipal Central Hospital

Dalian, China

RECRUITING

The First Affiliated Hospital of Harbin Medical University

Ha’erbin, China

RECRUITING

Affiliated Hospital of Inner Mongolia University for the Nationalities

Tongliao, China

RECRUITING

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

Central Study Contacts

Ruiwen Che

CONTACT

010-63925615; rwcadl@163.com

Shen Li

CONTACT

010-63925616; lishen@mail.ccmu.edu.cn

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 (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)