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

Intracerebral Hemorrhage Clinical Trial

— PRONTO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04178746
• Other study ID #: 14087
• Status: Terminated
• Start date: September 26, 2019
• Est. completion date: June 2, 2021

Study information

• Verified date: September 2022
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2, 2021
• Est. primary completion date: June 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Hemorrhage
• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Intracranial Hemorrhages
• Intraventricular Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
United States	Atlantic Neuroscience Institute	Summit	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Safety Endpoint: Rate of mortality at 30 days	Rate of mortality at 30 days	30 days
Secondary	Time of admission at treating facility to discharge (Length of stay)		admission to discharge, a period of up to 30 days
Secondary	Rate of Ventriculoperitoneal Shunt (VPS) placement within 30 days of procedure		30 days
Secondary	Procedure and device related SAEs		time of surgery up to 30-day follow-up