Cooling infusion combined with endovascular therapy for acute ischemic stroke

Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With Endovascular Thrombectomy in Acute Ischemic Stroke: A Multicenter, Randomized Controlled, Subject- and Assessor-Blind Clinical Trials

This study is testing if a new cooling treatment combined with a common stroke procedure can help people who have had a severe stroke feel better after 90 days.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 258 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Shijitan Hospital, Capital Medical University (Academic / other)
• Locations: 9 sites (Lanzhou, Gansu and 8 other locations)
• Trial ID: NCT06485427 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, controlled trial evaluates the safety and efficacy of selective intra-arterial cooling infusion (IA-SCI) combined with endovascular therapy (EVT) for patients suffering from acute ischemic stroke due to large vessel occlusion. Participants will be randomly assigned to receive either the IA-SCI treatment or best medical management along with EVT. The study aims to enroll 258 subjects and will assess outcomes through various interviews at specified intervals post-treatment. The primary outcome measure is the distribution of the Modified Rankin Score at 90 days after randomization.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with acute ischemic stroke and large vessel occlusion in the anterior circulation.

Not a fit: Patients with multiple vascular territory strokes or evidence of intracranial hemorrhage will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve functional independence and clinical outcomes for patients with acute ischemic stroke.

How similar studies have performed: Previous studies have indicated that selective intra-arterial cooling infusion combined with EVT is safe and feasible, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria

1. Age ≥ 18 and ≤ 80.
2. 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.
3. NIHSS score obtained prior to randomization ≥ 6 and ≤ 25.
4. Modified Rankin Scale ≤ 1 prior to qualifying stroke.
5. Arterial puncture performed within 24 hours from symptom onset or LKW.
6. 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.
7. Patient/Legally Authorized Representative has signed the Informed Consent Form.

Exclusion Criteria

1. Baseline CT/MRI confirms the presence of multiple vascular territory acute strokes.
2. Baseline CT/MRI confirms the presence of arterial dissection.
3. Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
4. Known allergies or intolerances to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics.
5. Severe infection (e.g. sepsis) or multiple organ failure.
6. 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.
7. Baseline platelet count \< 50 × 10\^9/L.
8. Blood glucose concentration\<50 mg/dL (2.7 mmol/L) or \>400 mg/dL (22.2 mmol/L).
9. Refractory hypertension that is difficult to control by medication (Defined as persistent systolic blood pressure\>185 mmHg or diastolic blood pressure\>110 mmHg).
10. Previous NHYA\>1.
11. Untreated moderate or severe coronary artery stenosis, or previous coronary artery bypass surgery.
12. 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).
13. Known intracranial aneurysm, and cerebral arteriovenous malformation.
14. Malignant brain tumor or CNS infection.
15. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g., dementia or mental illness)
16. Female who is pregnant or lactating at time of admission.
17. Anticipated life expectancy \< 6 months.
18. Current participation in another investigational drug or device study.
19. For other reasons, the responsible clinicians believe that the patient is not suitable for continued treatment.

Where this trial is running

Lanzhou, Gansu and 8 other locations

• 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)

Study contacts

• Principal investigator: Shen Li — Beijing Shijitan Hospital, Capital Medical University
• Study coordinator: Ruiwen Che

Conditions Acute Ischemic Stroke; Hypothermia