A Trial of Adacolumn on Cerebral Edema After Anterior Circulation Ischemic Stroke

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

The primary objective is to investigate whether treatment with Adacolumn can ameliorate the progression of cerebral edema within 72 hours in patients with anterior circulation ischemic stroke. The secondary objective is to explore if Adacolumn could improve acute neurologic status, functional outcomes, treatment requirements and safety in patients with anterior circulation ischemic stroke.

Eligibility criteria

Qualifiers

Age 18-80 years, regardless of gender;

A clinical diagnosis of acute ischemic stroke;

Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions) determined by MRA or CTA or DSA;

NIHSS score ≥10 at screening;

Disqualifiers

Decompressive craniectomy performed before enrollment or between enrollment and initiation of study treatment;

Patients who receive intravenous thrombolysis (including bridging therapy) for the index ischemic stroke episode before or during endovascular thrombectomy; or undergo permanent intracranial or extracranial stent implantation (including intracranial stent-assisted thrombectomy or carotid stenting) during the index endovascular procedure;

After endovascular thrombectomy: extensive contrast extravasation (diffuse subarachnoid high density or parenchymal high density not consistent with hematoma), new subarachnoid hemorrhage(SAH), or symptomatic intracranial hemorrhage (sICH);

Large-vessel occlusion is attributed to other determined etiologies per TOAST classification, such as tumor-related, dissection-related, or other clearly identifiable non-LAA/non-CE causes.

Trial design

Treatments tested in this trial

  • Adacolumn®
  • Endovascular Thrombectomy
  • Standard medical management

Treatment groups

10 Participants
are divided into 2 treatment groups