Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation

NCT ID: NCT07260916

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2030-06-30

Brief Summary

MINUTE is a prospective, multi-center, randomized, controlled, blinded assessor, adaptive enrichment design, clinical trial. Eligible patients with spontaneous BGH ≥20 mL will be randomized 1:1 to either minimally invasive endoscopic SCUBA evacuation plus standard medical management or standard medical management alone; the time of randomization will be used to classify participants in one of two cohorts: 1) those randomized <8 hours from onset, and 2) those randomized 8-16 hours from onset. Randomization is targeted to occur within 120 min of arrival to the randomizing center's Emergency Department (ED), and initiation of surgery is targeted to occur within 120 min of randomization. Participants will be followed at 30, 90, 180, and 365 days to assess for adverse events (AEs) and utility-weighted modified Rankin Scale (UW-mRS).

Conditions

Basal Ganglia Intracerebral Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Endoscopic ICH evacuation (SCUBA) and Standard Medical Treatment

Participants will be treated with SCUBA and Standard Medical Treatment

Group Type: EXPERIMENTAL

Endoscopic ICH evacuation

Intervention Type: PROCEDURE

The intervention is minimally invasive endoscopic ICH evacuation using the SCUBA approach29. Stereotactic guidance must be used to guide placement of the sheath into the hematoma. Using stereotactic guidance software, a trajectory is planned along the long axis of the hematoma to the skull while avoiding eloquent brain regions, prominent vasculature, and other anatomy that should not be traversed during the approach, such as the frontal sinuses. A tele-proctor will be available to review the trajectory prior to the procedure starting. The procedure is performed under general anesthesia. The patient's head can be fixed if required depending on the stereotactic navigation system used.

Standard Medical Treatment

Intervention Type: OTHER

Participating physicians will attest that they will manage all ICH patients in the medical and surgical arms of the trial according to their institutional standards of care, which they will attest are consistent with the American Stroke Association guidelines for management of spontaneous ICH66 and utilize a standardized blood pressure management and hydrocephalus management protocol.

Standard Medical Treatment

Participants will be treated with Standard Medical Treatment

Group Type: PLACEBO_COMPARATOR

Standard Medical Treatment

Intervention Type: OTHER

Participating physicians will attest that they will manage all ICH patients in the medical and surgical arms of the trial according to their institutional standards of care, which they will attest are consistent with the American Stroke Association guidelines for management of spontaneous ICH66 and utilize a standardized blood pressure management and hydrocephalus management protocol.

Interventions

Endoscopic ICH evacuation

The intervention is minimally invasive endoscopic ICH evacuation using the SCUBA approach29. Stereotactic guidance must be used to guide placement of the sheath into the hematoma. Using stereotactic guidance software, a trajectory is planned along the long axis of the hematoma to the skull while avoiding eloquent brain regions, prominent vasculature, and other anatomy that should not be traversed during the approach, such as the frontal sinuses. A tele-proctor will be available to review the trajectory prior to the procedure starting. The procedure is performed under general anesthesia. The patient's head can be fixed if required depending on the stereotactic navigation system used.

Intervention Type: PROCEDURE

Standard Medical Treatment

Participating physicians will attest that they will manage all ICH patients in the medical and surgical arms of the trial according to their institutional standards of care, which they will attest are consistent with the American Stroke Association guidelines for management of spontaneous ICH66 and utilize a standardized blood pressure management and hydrocephalus management protocol.

Intervention Type: OTHER

Other Intervention Names

SCUBA

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 and ≤ 80 years
• Non-traumatic, spontaneous, supratentorial, non-thalamic, BGH of volume ≥ 20 mL, as determined by the treating physician using ABC/2 method
• NIHSS ≥ 6 at presentation
• Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA) is performed and does not show an underlying vascular lesion
• Pre-ICH mRS 0-2 Informed consent from patient or legally authorized representative (LAR) to participate in the trial, wherein patient/LAR's stated wishes are to pursue lifesaving therapies as opposed to early withdrawal of care (explicitly explained as <7 days following ictus)
• The treating physician anticipates that surgery can be initiated <120 min from randomization
• Randomization can occur ≤16 hours from LKW

Exclusion Criteria

• Suspected secondary cause for the ICH, such as an underlying vascular malformation (cavernous malformation, arteriovenous malformation, etc.), aneurysm, neoplasm, hemorrhagic transformation of an underlying ischemic infarct; or venous infarct Infratentorial or thalamic hemorrhage
• Midbrain extension/involvement
• Coagulopathy defined as international normalized ratio (INR) > 1.4
• Elevated activated Partial Thromboplastin Time (aPTT) > 40 s
• Concurrent use of direct oral anticoagulants or low molecular weight heparin at ICH onset
• Known hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency
• Platelet count <100 x 103 cells/mm3, or known platelet dysfunction (reversal of coagulopathy is not allowed) GCS score <7 at presentation
• Evidence of active infection indicated by fever ≥100.7 °F and/or open draining wound at the time of enrollment
• Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
• Intraventricular extension of the hemorrhage is visually estimated to involve > 50% of either of the lateral ventricles
• Pregnancy (women of childbearing potential must have a negative pregnancy test to participate)
• Based on investigator's judgment, the patient does not have the necessary mental capacity to participate or is unwilling to comply with the protocol follow-up schedule
• Current participation in another interventional (drug or device) trial
• Pre-existing Do Not Resuscitate (DNR)/Do Not Intubate (DNI) status
• History of severe dementia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

NINDS Stroke Trials Network (StrokeNet)

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

J. Mocco

National Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

J Mocco, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital System

Magdy Selim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Sharon Yeatts, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Mount Sinai Health System

New York, New York, United States

Countries

United States

Central Contacts

Ally Qi, MPH

Role: CONTACT

ally.qi@mountsinai.org

2093303024

Sukaina Davdani

Role: CONTACT

sukaina.davdani@mountsinai.org

Facility Contacts

Emily Svendsen

Role: primary

emily.svendsen@mountsinai.org

212-241-3238

Other Identifiers

1UG3NS138638-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 23-1905

Identifier Type: -

Identifier Source: org_study_id