NCT06485427 Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke
| NCT ID | NCT06485427 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Shijitan Hospital, Capital Medical University |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 258 participants |
| Start Date | 2024-07-03 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 258 participants in total. It began in 2024-07-03 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Shen Li
PRINCIPAL INVESTIGATOR
Beijing Shijitan Hospital, Capital Medical University
Frequently Asked Questions
Who can join the NCT06485427 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06485427 currently recruiting?
Yes, NCT06485427 is actively recruiting participants. Contact the research team at rwcadl@163.com for enrollment information.
Where is the NCT06485427 trial being conducted?
This trial is being conducted at Lanzhou, China, Nanyang, China, Xuzhou, China, Beijing, China and 5 additional locations.
Who is sponsoring the NCT06485427 clinical trial?
NCT06485427 is sponsored by Beijing Shijitan Hospital, Capital Medical University. The principal investigator is Shen Li at Beijing Shijitan Hospital, Capital Medical University. The trial plans to enroll 258 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.