PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute Phase

Study Overview
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Brief Summary
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The purpose of this prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in subjects with intraventricular hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase.

Detailed Description
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The purpose of this prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in subjects with intracerebral hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase. The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems. The enrollment period will end once 20 evaluable subjects have been enrolled in the registry. Each subject will be in the registry for approximately 1 month.

Official Title
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PRONTO: Minimally Invasive Endoscopic Surgery Utilizing the Artemis Neuro Evacuation Device in Patients With Intraventricular Hemorrhage in the Hyper-Acute Phase

Conditions
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Intracerebral Hemorrhage, Brain Hemorrhage, Intraventricular Hemorrhage

Intervention / Treatment
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* Device: Artemis Neuro Evacuation Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years in age Patients presenting with Intraventricular Hemorrhage (IVH) qualifying for hematoma evacuation Controlled SBP ≤ 180 mmHg after initial NCCT scan and prior to the initiation of the MIS procedure Hyper-acute phase, as defined by initiation of the MIS procedure no longer than 12 hours from initial NCCT scan and no longer than 18 hours since time patient last known well Symptomatic with radiographic evidence of cerebral compression edema Pre-stroke mRS 0 - 2 Exclusion Criteria: Presence of tentorial herniation and/or Kernohan's phenomenon Uncontrolled ICP as defined as > 25 mmHg for more than 30 min for 3 consecutive hours after External Ventricular Drain (EVD) placement Requirement of insulin drip Pregnancy or positive pregnancy test (either serum or urine). Women of child-bearing potential must have a negative pregnancy test prior to enrollment Unable to obtain consent from patient or legally authorized representative (LAR) (for patients without competence) Presenting epilepticus that is not controlled Nonreversible coagulopathy (INR > 1.4) or platelet deficiency (< 75 x 103 cells/mm3) not able to be corrected with currently accepted treatment medications Contraindication to conventional angiography, CTA, and MRA Life expectancy of < 2 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IVH subjects in the Hyper-Acute Phase<br>The purpose of this prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in approximately 20 subjects with intracerebral hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase. For the purposes of this registry, the hyper-acute phase as defined by initiation of the MIS procedure no longer than 12 hours from initial NCCT scans and no longer than 18 hours since time patients last known well. | Device: Artemis Neuro Evacuation Device<br>* The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems. The Artemis Device will be evaluated by descriptive statistics in this registry to assess its efficiency and reliability in minimally invasive, mechanical evacuation of hematoma in patients with intracranial hemorrhage under direct visualization and control using a neuroendoscope.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Endpoint: Post-Procedural Hemorrhage reduction of ≥ 85% in hemorrhage volume assessed by CT at 24 hours | Post-Procedural Hemorrhage reduction of ≥ 85% in hemorrhage volume assessed by CT at 24 hours | 24 hours | 
| Safety Endpoint: Rate of mortality at 30 days | Rate of mortality at 30 days | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of admission at treating facility to discharge (Length of stay) |  | admission to discharge, a period of up to 30 days | 
| Rate of Ventriculoperitoneal Shunt (VPS) placement within 30 days of procedure |  | 30 days | 
| Procedure and device related SAEs |  | time of surgery up to 30-day follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraventricular hemorrhage, IVH, stroke