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 range18 Years

SexALL

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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

✕. 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
✕

What they're measuring

Efficacy Endpoint: Post-Procedural Hemorrhage reduction of ≥ 85% in hemorrhage volume assessed by CT at 24 hours

Timeframe: 24 hours

Safety Endpoint: Rate of mortality at 30 days

Timeframe: 30 days

Trial details

NCT IDNCT04178746

SponsorPenumbra Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-06-02

View on ClinicalTrials.gov More Intracerebral Hemorrhage trials