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

NCT ID: NCT04178746

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-26
• Study Completion Date: 2021-06-02

Brief Summary

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

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.

Conditions

Intracerebral Hemorrhage; Brain Hemorrhage; Intraventricular Hemorrhage

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Artemis Neuro Evacuation Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

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

Sponsors

Penumbra Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Saphier, MD

Role: PRINCIPAL_INVESTIGATOR

Atlantic Neuroscience Institute

Locations

Atlantic Neuroscience Institute

Summit, New Jersey, United States

Countries

United States

Other Identifiers

14087

Identifier Type: -

Identifier Source: org_study_id