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New brain clot removal device shows promise in stroke study

NCT ID NCT03342664

Disease control Sponsor: Penumbra Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device called Artemis that removes blood clots from the brain through a small hole, instead of open surgery. It included 236 adults aged 18 to 80 with a specific type of brain hemorrhage. The goal was to see if this less invasive approach leads to better recovery and lower death rates compared to standard medical treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

236 people

The number who actually took part.

Started

Feb 2018

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient age ≥ 18 and ≤ 80 2. Supratentorial ICH of volume ≥ 20 and ≤ 80 cc (measured using A x B X C/2 method) 3. Hemostasis as confirmed by no arterial spot sign (may perform additional scan(s) every 6 hours to demonstrate hemostasis) 4. NIHSS ≥ 6 5. GCS ≥ 5 and ≤ 15 6. Historical mRS 0 or 1 7. Symptom onset \< 24 hours prior to initial CT/MR 8. MIS must be initiated within 72 hours of ictus/bleed 9. SBP must be \< 180 mmHg and controlled at this level for at least 6 hours Exclusion Criteria: 1. Imaging 1. "Arterial Spot Sign" identified on final CTA indicating expanding hemorrhage 2. Hemorrhagic lesion such as a vascular malformation (cavernous malformation, AVM etc.), aneurysm, and/or neoplasm 3. Hemorrhagic conversion of an underlying ischemic stroke 4. Infratentorial hemorrhage 5. Primary thalamic ICH (where the center of the hemorrhage emulates from the thalamus) 6. Associated intra-ventricular hemorrhage requiring treatment for IVH-related mass effect or shift due to trapped ventricle (EVD for ICP management is allowed) 7. Midbrain extension/involvement 8. Absolute contraindication to CTA, conventional angiography and MRA 2. Coagulation Issues 1. Absolute requirement for long-term anti-coagulation (e.g., mechanical valve replacement (bio-prostatic valve is permitted), high risk atrial fibrillation) 2. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency 3. Platelet count \< 100 x 10\^3 cells/mm3 or known platelet dysfunction 4. INR \> 1.4, elevated prothrombin time or activated partial thromboplastin time (aPTT), which cannot be corrected or otherwise accounted for (i.e., lupus anti-coagulant) 5. Use of direct factor Xa inhibitors (e.g. apixaban, rivaroxaban, fondaparinux) within last 48 hours 3. Patient Factors 1. Traumatic ICH 2. High risk atrial fibrillation (e.g., mitral stenosis with atrial fibrillation) and/or symptomatic carotid stenosis 3. Requirement for emergent surgical decompression or uncontrolled ICP after EVD 4. Unable to obtain consent per Institution Review Board/Ethics Committee policy 5. Pregnancy or positive pregnancy test (either serum or urine). Women of child-bearing potential must have a negative pregnancy test prior to enrollment 6. Severe active infection requiring treatment (e.g. sepsis or purulent wound) at the time of enrollment 7. Renal failure indicated by creatinine \> 2 mg/dL or undergoing dialysis 8. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days 9. Based on investigator's judgement, patient is unwilling or unable to comply with protocol follow up appointment schedule 10. Active drug or alcohol use or dependence that, in the opinion of the site investigator would interfere with adherence to study requirements 11. Currently participating in another interventional (drug, device, etc) clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.

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Conditions

The condition(s) this trial relates to.

cerebrovascular disorder Hemorrhage hemorrhagic stroke intracerebral hemorrhage Intracranial Hemorrhages stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain hemorrhage Cerebral hemorrhage Cerebral parenchymal hemorrhage Intracerebral hemorrhage

Contacts and locations

Locations

  • Abrazo Central

    Phoenix, Arizona, 85015, United States

  • Atlantic Neuroscience Institute

    Summit, New Jersey, 07901, United States

  • Charité - Universitätsmedizin Berlin

    Berlin, Germany

  • Christiana Health

    Newark, Delaware, 19718, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • George Washington

    Washington D.C., District of Columbia, 20052, United States

  • Harborview Medical Center

    Seattle, Washington, 98104, United States

  • Loyola University Chicago

    Chicago, Illinois, 60660, United States

  • MUSC

    Charleston, South Carolina, 29425, United States

  • Maimonides

    Brooklyn, New York, 11219, United States

  • Methodist University Hospital

    Memphis, Tennessee, 38120, United States

  • Mission Hospital

    Mission Viejo, California, 92691, United States

  • Mount Sinai

    New York, New York, 10029, United States

  • München Klinik Bogenhausen

    München, Germany

  • Northwell Health

    Manhasset, New York, 11030, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Novant Health

    Charlotte, North Carolina, 28277, United States

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121, United States

  • Stony Brook University

    Stony Brook, New York, 11794, United States

  • Swedish - HCA

    Englewood, Colorado, 80113, United States

  • UCLA

    Los Angeles, California, 90095, United States

  • Uniklinikum Salzburg

    Salzburg, Austria

  • University Hospital Cleveland

    Cleveland, Ohio, 44106, United States

  • University of Alberta

    Edmonton, Alberta, Canada

  • University of Kentucky

    Lexington, Kentucky, 40506, United States

  • University of Louisville

    Louisville, Kentucky, 40292, United States

  • University of Mississippi

    Jackson, Mississippi, 39216, United States

  • University of Missouri

    Columbia, Missouri, 65211, United States

  • Universitätsklinikum Augsburg

    Augsburg, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Germany

  • Valley Baptist Medical Center

    Harlingen, Texas, 78520, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

  • Yale University

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.