Clinical trial NCT04178746: PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute Phase
Official title: PRONTO: Minimally Invasive Endoscopic Surgery Utilizing the Artemis Neuro Evacuation Device in Patients With Intraventricular Hemorrhage in the Hyper-Acute Phase
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Intracerebral Hemorrhage
Brain Hemorrhage
Intraventricular Hemorrhage
Keywords: intraventricular hemorrhage
IVH
stroke
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-26
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with spontaneous Intraventricular Hemorrhage not related to underlying vascular abnormality.

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.

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

Primary outcomes:
measure: Efficacy Endpoint: Post-Procedural Hemorrhage reduction of ≥ 85% in hemorrhage volume assessed by CT at 24 hours
timeFrame: 24 hours
measure: Safety Endpoint: Rate of mortality at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Time of admission at treating facility to discharge (Length of stay)
timeFrame: admission to discharge, a period of up to 30 days
measure: Rate of Ventriculoperitoneal Shunt (VPS) placement within 30 days of procedure
timeFrame: 30 days
measure: Procedure and device related SAEs
timeFrame: time of surgery up to 30-day follow-up
Other outcomes:
Locations:
city: Summit
country: United States
facility: Atlantic Neuroscience Institute
state: New Jersey
Study officials:
affiliation: Atlantic Neuroscience Institute
name: Paul Saphier, MD
role: PRINCIPAL_INVESTIGATOR
References: