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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Shijitan Hospital, Capital Medical University

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

258 Participants
are divided into 2 treatment groups