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

NCT04178746 | Terminated DMC FDA Device

• 1 other identifier: 14087
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracerebral Hemorrhage; Brain Hemorrhage; Intraventricular Hemorrhage

Keywords

intraventricular hemorrhage; IVH; stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (1)

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

Interventions

Artemis Neuro Evacuation Device 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.

IVH subjects in the Hyper-Acute Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (1)

Atlantic Neuroscience Institute

Summit, New Jersey, 07901, United States

Location

MeSH Terms

Conditions

Cerebral Hemorrhage; Intracranial Hemorrhages; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Saphier, MD

  Atlantic Neuroscience Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 26, 2019
• Study Start: September 26, 2019
• Primary Completion: June 2, 2021
• Study Completion: June 2, 2021
• Last Updated: September 14, 2022

Record last verified: 2022-09

Locations

US (1)