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

PRONTO: Minimally Invasive Endoscopic Surgery Utilizing the Artemis Neuro Evacuation Device in Patients With Intraventricular Hemorrhage 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 subjects with intraventricular hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase.

Study Overview

• Status: Terminated
• Conditions: Intraventricular Hemorrhage; Intracerebral Hemorrhage; Brain Hemorrhage
• Intervention / Treatment: Device: Artemis Neuro Evacuation Device

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Atlantic Neuroscience Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with spontaneous Intraventricular Hemorrhage not related to underlying vascular abnormality.

Description

Inclusion Criteria:

1. ≥ 18 years in age
2. Patients presenting with Intraventricular Hemorrhage (IVH) qualifying for hematoma evacuation
3. Controlled SBP ≤ 180 mmHg after initial NCCT scan and prior to the initiation of the MIS procedure
4. 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
5. Symptomatic with radiographic evidence of cerebral compression edema
6. Pre-stroke mRS 0 - 2

Exclusion Criteria:

1. Presence of tentorial herniation and/or Kernohan's phenomenon
2. Uncontrolled ICP as defined as > 25 mmHg for more than 30 min for 3 consecutive hours after External Ventricular Drain (EVD) placement
3. Requirement of insulin drip
4. Pregnancy or positive pregnancy test (either serum or urine). Women of child-bearing potential must have a negative pregnancy test prior to enrollment
5. Unable to obtain consent from patient or legally authorized representative (LAR) (for patients without competence)
6. Presenting epilepticus that is not controlled
7. Nonreversible coagulopathy (INR > 1.4) or platelet deficiency (< 75 x 103 cells/mm3) not able to be corrected with currently accepted treatment medications
8. Contraindication to conventional angiography, CTA, and MRA
9. Life expectancy of < 2 months

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Penumbra Inc.
• Investigators: Principal Investigator: Paul Saphier, MD, Atlantic Neuroscience Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Actual): June 2, 2021
• Study Completion (Actual): June 2, 2021

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: stroke; intraventricular hemorrhage; IVH
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hemorrhage; Intracranial Hemorrhages; Cerebral Hemorrhage
• Other Study ID Numbers: 14087

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes