PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute Phase
Stopped early
Conditions studied: Intracerebral Hemorrhage, Brain Hemorrhage, Intraventricular Hemorrhage
In brief
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.
Key facts
- Study ID
- NCT04178746
- Run by
- Penumbra Inc.
- People needed
- 4
- Starts
- 2019-09-26
- Expected to finish
- 2021-06-02
- Last updated by the study team
- 2022-09-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Atlantic Neuroscience Institute — Summit, New Jersey, United States
Full record on ClinicalTrials.gov
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