EDAS Revascularization for Symptomatic Intracranial Atherosclerotic Steno-occlusive Disease

Study acronym: ERSIAS IIb
StatusNot Yet Recruiting
PhaseNot applicable
Started

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Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Primary endpoint(s) modified
    • Study title shortened, about 2 words
  2. Study First Submitted
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ERSIAS IIb is a multicenter randomized controlled trial, with a Phase IIb design, to find out whether encephaloduroarteriosynangiosis (EDAS), a type of indirect surgical revascularization of the brain, added to intensive medical management, lowers the rate of recurrent stroke and death compared with intensive medical management alone. The trial enrolls 170 adults who have had a recent ischemic stroke or transient ischemic attack caused by intracranial atherosclerotic disease, with a narrowing or blockage of at least 70% of the intracranial internal carotid artery or the middle cerebral artery and reduced blood flow in the territory of that artery. Participants are assigned at random, in equal numbers, to EDAS plus intensive medical management or to intensive medical management alone, and are followed for 18 to 54 months.
Trial Details
NCT Number NCT07864649
Lead Sponsor Cedars-Sinai Medical Center
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions
(from sponsor)		 Intracranial Atherosclerosis, Intracranial Arterial Stenosis, Ischemic Stroke
Related terms Intracranial Arteriosclerosis, Ischemic Stroke
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov