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

Sponsor

Penumbra Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04178746

Collaborator

(none)

Enrollment

Location

60.2

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Intracerebral Hemorrhage Brain Hemorrhage Intraventricular Hemorrhage	Device: Artemis Neuro Evacuation Device

Detailed Description

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

20 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 26, 2019

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
IVH subjects in the Hyper-Acute Phase 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 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.

Arm

Intervention/Treatment

IVH subjects in the Hyper-Acute Phase

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

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.

Outcome Measures

Primary Outcome Measures

Efficacy Endpoint: Post-Procedural Hemorrhage reduction of ≥ 85% in hemorrhage volume assessed by CT at 24 hours [24 hours]
Post-Procedural Hemorrhage reduction of ≥ 85% in hemorrhage volume assessed by CT at 24 hours
Safety Endpoint: Rate of mortality at 30 days [30 days]
Rate of mortality at 30 days

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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