PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute Phase (NCT04178746) | Clinical Trial Compass
TerminatedNot Applicable
PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute Phase
Stopped: Business decision to focus on other studies. No safety concern.
United States4 participantsStarted 2019-09-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥ 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy Endpoint: Post-Procedural Hemorrhage reduction of ≥ 85% in hemorrhage volume assessed by CT at 24 hours
. 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