Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation (MINUTE) Trial

Icahn School Of Medicine At Mount Sinai, New York NY

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Abstract

ABSTRACT An estimated 1,700,000 people worldwide suffer from an intracerebral hemorrhage (ICH) every year. Recent presentation of StrokeNet Site Survey data revealed that the top two “Acute Research Priorities” were the “Medical and Surgical Treatment of ICH” (StrokeNet National Investigator Meeting on October 9th, 2023, Toronto). The ENRICH trial demonstrated clinical benefit for surgical evacuation of lobar hemorrhages within 24 hours but did not find benefit for basal ganglia hemorrhages (BGH). Deep ICH, often due to hypertension, is the most common ICH subtype (up to 69% in some studies), particularly in under-represented racial/ethnic populations. Amongst 35-75 year olds, African Americans have twice the annual incidence of deep ICH than whites. BGH represents half of all deep ICH. There is an unmet need for effective treatments for this devastating disease. ENRICH's lack of efficacy in BGH may be secondary to the large craniotomy required by the ENRICH approach (a 13.8-15.8 mm dissection path through the brain) or the time to surgery (median 16.8h (IQR: 11-21h), as literature suggests earlier evacuation may result in better outcomes. We hypothesize that a minimally invasive endoscopic clot evacuation technique, called SCUBA, is an attractive and logical approach to improve outcomes when performed early (within 8-16h) or ultra-early (<8h) after BGH onset. A total of 300 subjects with spontaneous BGH will be randomized to either SCUBA endoscopic evacuation or standard non- surgical medical therapy. Our specific aim is: To evaluate the utility of SCUBA in BGH patients with LKW-to- randomization time ≤16h, and to determine whether confirmatory study in either <8h, 8-16h, or both cohorts is indicated. The primary efficacy endpoint is UW-mRS at 180 days. Successful study completion will provide crucial safety and feasibility information for early/ultra-early BG ICH evacuation using SCUBA. A successful treatment for BGH would have major global public health significance.