ClinicalTrials.gg
CompletedNCT03342664Updated Jan 30, 2026Results posted

MIND: Artemis in the Removal of Intracerebral Hemorrhage

An interventional study of Artemis + Medical Management and Best Medical Management Alone (MM) in Cerebral Hemorrhage, Brain Hemorrhage and Cerebral Parenchymal Hemorrhage, sponsored by Penumbra Inc.. Completed at 33 sites in 4 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-30.

Sponsored by Penumbra Inc. · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
236
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 109 studies in Cerebral Hemorrhage with a site in United States — 31 open to participants now, 42 under way, 6 of them phase 3. Cerebral Hemorrhage · United States.

Enrollment
21st of 71
236 · median 60
Started
2018
with 2 others
No phase
25 of 109
9 open now
Registered
51st of 109
by date
Lead sponsor
3 of 109
Penumbra Inc.

Among the 109 studies in Cerebral Hemorrhage with a site in United States, this one is the 21st largest by enrollment of the 71 interventional ones that give a count, is one of 3 that started in 2018, is one of 25 with no phase, and was the 51st registered.

Cerebral Hemorrhage

457 studies on the registry are indexed under Cerebral Hemorrhage; 172 are open to participants now.

Browse Cerebral Hemorrhage studies →

Open to participants now

31 of the 109 studies in Cerebral Hemorrhage with a site in United States are open now. Recruiting first, the newest first:

26 more — sign in →

All 31 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 112 Cerebral Hemorrhage studies recruiting now, 58 (52%) set no upper age limit and 9 (8%) stop at 75 or younger; 1 takes children under 18; 6 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study summary

The primary objective of this multicenter randomized controlled study is to compare the safety and efficacy of minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device to best medical management for the treatment of intracerebral hemorrhage (ICH).

03

Conditions studied

  • Cerebral Hemorrhage
  • Brain Hemorrhage
  • Cerebral Parenchymal Hemorrhage
  • Intracerebral Hemorrhage

Keywords

  • ICH
  • Stroke
  • Cerebral Hemorrhage
  • Intracranial Hemorrhage
  • Hemorrhage
  • Cerebrovascular Disorders
  • Brain bleed
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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. count \< 100 x 10\^3 cells/mm3 or known platelet dysfunction
    4. > 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 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
236 participants (actual)

Study arms

  • Experimental
    Artemis + Medical Management (MIS)

    Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management

    Device: Artemis + Medical Management

  • Active comparator
    Best Medical Management Alone (MM)

    Best medical management alone per standard of care at treating institution

    Other: Best Medical Management Alone (MM)

Interventions

  • DeviceArtemis + Medical Management

    Subject will receive best MM in addition to the MIS procedure with Artemis.

    Also known as: MIS + MM

  • OtherBest Medical Management Alone (MM)

    Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.

    Also known as: MM, Control

06

What researchers measure

Primary outcomes

  1. Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)

    Modified Rankin scale measures degree of disability or functional impairment on a scale of 0 (no symptoms) to 5 (severe disability), 6 (expired), where higher scores mean a worse outcome

    Time frame: 180 days

  2. Rate of Mortality

    Time frame: 30 days

Secondary outcomes

  1. Functional Outcomes Measured Via Utility Weighted Modified Rankin Score (mRS)

    The utility-weighted modified Rankin Score (utility-weighted mRS) is a functional outcome measure that quantifies global disability. It is derived from the Ordinal Modified Rankin Scale (mRS), which assesses the degree of disability or functional impairment on a scale. The underlying Modified Rankin Scale categories range from 0 to 6, where: * 0 = No symptoms (best outcome) * 6 = Death (worst outcome) These categorical mRS values are converted to utility weights and the resulting the utility-weighted mRS produces a continuous score ranging from 0.00 to 1.00, where: * 0.00 represents the worst functional outcome (equivalent to severe disability or death) * 1.00 represents the best functional outcome (no symptoms and full independence) Higher scores indicate better functional outcomes. Lower scores indicate worse functional outcomes.

    Time frame: 180 days

  2. Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS)

    Modified Rankin scale measures degree of disability or functional impairment on a scale of 0 (no symptoms) to 5 (severe disability), 6 (expired), where higher scores mean a worse outcome

    Time frame: 365 days

  3. Quality of Life Assessed Via Stroke Impact Scale

    The Stroke Impact Scale measures mobility and activities of daily living by assessing ability to perform specific physical tasks using a 5-point scale that ranges from 1 (could not do it at all) to 5 (not difficult at all). The individual scores are converted to a scale of 0 (no recovery) -100 (full recovery) to represent level of recovery, where a higher score means better outcome.

    Time frame: 180 and 365 days

  4. VAS Quality of Life Assessed Via EQ-5D-5L

    The EQ-5D-5L (EuroQol 5 Dimension 5 Level) is a self assessment on activities of daily living using a visual analog scale (VAS) where current health is rated on a scale of 0 to 100 where 0 is the worst imaginable health and 100 is the best imaginable health.

    Time frame: 180 and 365 days

  5. Length of Hospital Stay

    Time frame: Admission to hospital discharge (up to one year)

  6. Length of ICU

    Time frame: # of days from admission (up to one year)

  7. Length of Procedure

    Time frame: Time from initial sheath placement to final sheath removal

  8. Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 3

    (0 no symptoms - 3 moderate disability)

    Time frame: 180 days

  9. Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 2

    mRS 0 no symptoms - 2 slight disability

    Time frame: 180 days

07

Results

Posted Jan 30, 2026

Participant flow

Participant flow — Overall Study
MilestoneArtemis + Medical Management (MIS)Best Medical Management Alone (MM)
Started15482
Completed13970
Not completed1512

Outcome measures

PrimaryGlobal Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)

Modified Rankin scale measures degree of disability or functional impairment on a scale of 0 (no symptoms) to 5 (severe disability), 6 (expired), where higher scores mean a worse outcome

Time frame:
180 days
Reported as:
Count of participants · Participants
Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)
ParticipantsArtemis + Medical Management (MIS)Best Medical Management Alone (MM)
Missing mRS value3220
mRS 042
mRS 151
mRS 2118
mRS 32814
mRS 43813
mRS 51410
mRS 62214
Statistical analysis
  • Artemis + Medical Management (MIS) vs Best Medical Management Alone (MM) · Odds ratio (or): 1.03 · 96% CI 0.62 to 1.72Odds ratio of MIS over MM with value above 1 indicating a better outcome for MIS
PrimaryRate of Mortality
Time frame:
30 days
Reported as:
Count of participants · Participants
Rate of Mortality
ParticipantsArtemis + Medical Management (MIS)Best Medical Management Alone (MM)
Rate of Mortality118
SecondaryFunctional Outcomes Measured Via Utility Weighted Modified Rankin Score (mRS)

The utility-weighted modified Rankin Score (utility-weighted mRS) is a functional outcome measure that quantifies global disability. It is derived from the Ordinal Modified Rankin Scale (mRS), which assesses the degree of disability or functional impairment on a scale. The underlying Modified Rankin Scale categories range from 0 to 6, where: * 0 = No symptoms (best outcome) * 6 = Death (worst outcome) These categorical mRS values are converted to utility weights and the resulting the utility-weighted mRS produces a continuous score ranging from 0.00 to 1.00, where: * 0.00 represents the worst functional outcome (equivalent to severe disability or death) * 1.00 represents the best functional outcome (no symptoms and full independence) Higher scores indicate better functional outcomes. Lower scores indicate worse functional outcomes.

Time frame:
180 days
Reported as:
Mean · score on a scale
Functional Outcomes Measured Via Utility Weighted Modified Rankin Score (mRS)
score on a scaleArtemis + Medical Management (MIS)Best Medical Management Alone (MM)
Functional Outcomes Measured Via Utility Weighted Modified Rankin Score (mRS)0.41 ± 0.3140.38 ± 0.318
SecondaryFunctional Outcomes Measured Via Modified Ordinal Rankin Score (mRS)

Modified Rankin scale measures degree of disability or functional impairment on a scale of 0 (no symptoms) to 5 (severe disability), 6 (expired), where higher scores mean a worse outcome

Time frame:
365 days
Reported as:
Count of participants · Participants
Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS)
ParticipantsArtemis + Medical Management (MIS) All Participants All ParticipantsBest Medical Management Alone (MM)
Missing mRS value1512
mRS 040
mRS 1156
mRS 21115
mRS 33112
mRS 44514
mRS 567
mRS 62716
Statistical analysis
  • Artemis + Medical Management (MIS) All Participants All Participants vs Best Medical Management Alone (MM) · Odds ratio (or): 1.07 · 95% CI 0.64 to 1.79Odds ratio of MIS over MM with value above 1 indicating a better outcome for MIS
SecondaryQuality of Life Assessed Via Stroke Impact Scale

The Stroke Impact Scale measures mobility and activities of daily living by assessing ability to perform specific physical tasks using a 5-point scale that ranges from 1 (could not do it at all) to 5 (not difficult at all). The individual scores are converted to a scale of 0 (no recovery) -100 (full recovery) to represent level of recovery, where a higher score means better outcome.

Time frame:
180 and 365 days
Reported as:
Mean · score on a scale
Quality of Life Assessed Via Stroke Impact Scale
score on a scaleArtemis + Medical Management (MIS)Best Medical Management Alone (MM)
Mobility (180 days)54.3 ± 33.6753.9 ± 34.19
Activities of Daily Living (180 days)53.4 ± 31.8953.8 ± 32.59
Mobility (365 days)55.0 ± 32.5158.4 ± 33.99
Activities of Daily Living (365 days)55.8 ± 30.6656.2 ± 33.40
SecondaryVAS Quality of Life Assessed Via EQ-5D-5L

The EQ-5D-5L (EuroQol 5 Dimension 5 Level) is a self assessment on activities of daily living using a visual analog scale (VAS) where current health is rated on a scale of 0 to 100 where 0 is the worst imaginable health and 100 is the best imaginable health.

Time frame:
180 and 365 days
Reported as:
Mean · score on a scale
VAS Quality of Life Assessed Via EQ-5D-5L
score on a scaleArtemis + Medical Management (MIS)Best Medical Management Alone (MM)
EQ-5D-5L-180 days61.6 ± 23.4162.4 ± 22.82
EQ-5D-5L-365 days62.7 ± 22.4266.0 ± 22.03
SecondaryLength of Hospital Stay
Time frame:
Admission to hospital discharge (up to one year)
Reported as:
Mean · days
Length of Hospital Stay
daysArtemis + Medical Management (MIS)Best Medical Management Alone (MM)
Length of Hospital Stay18.8 ± 17.8120.6 ± 12.75
SecondaryLength of ICU
Time frame:
# of days from admission (up to one year)
Reported as:
Mean · days
Length of ICU
daysArtemis + Medical Management (MIS)Best Medical Management Alone (MM)
Length of ICU7.6 ± 6.519.2 ± 8.39
SecondaryLength of Procedure
Time frame:
Time from initial sheath placement to final sheath removal
Reported as:
Mean · minutes
Length of Procedure
minutesArtemis + Medical Management (MIS)Best Medical Management Alone (MM)
Length of Procedure41 ± 29.8134 ± NA
SecondaryFunctional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 3

(0 no symptoms - 3 moderate disability)

Time frame:
180 days
Reported as:
Count of participants · Participants
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 3
ParticipantsArtemis + Medical Management (MIS)Best Medical Management Alone (MM)
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 35732
SecondaryFunctional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 2

mRS 0 no symptoms - 2 slight disability

Time frame:
180 days
Reported as:
Count of participants · Participants
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 2
ParticipantsArtemis + Medical Management (MIS)Best Medical Management Alone (MM)
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 22614

Adverse events

Collected over Within 365 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Artemis + Medical Management (MIS)27/154 (17.5%)89/154 (57.8%)107/154 (69.5%)
Best Medical Management Alone (MM)16/82 (19.5%)60/82 (73.2%)56/82 (68.3%)
Most frequent serious events
Showing 10 of 243
Most frequent serious events
EventArtemis + Medical Management (MIS)Best Medical Management Alone (MM)
Brain oedemaNervous system disorders4/15410/82
Cerebral haemorrhageNervous system disorders17/1543/82
SepsisInfections and infestations4/1549/82
Deep vein thrombosisVascular disorders9/1549/82
PneumoniaInfections and infestations4/1547/82
Pulmonary embolismRespiratory, thoracic and mediastinal disorders6/1546/82
Ischaemic strokeNervous system disorders3/1544/82
Respiratory failureRespiratory, thoracic and mediastinal disorders6/1544/82
Haemorrhage intracranialNervous system disorders7/1542/82
SeizureNervous system disorders6/1541/82
Most frequent other events
Showing 10 of 246
Most frequent other events
EventArtemis + Medical Management (MIS)Best Medical Management Alone (MM)
TotalInfections and infestations41/15420/82
DysphagiaGastrointestinal disorders15/15412/82
Urinary tract infectionInfections and infestations17/1547/82
PneumoniaInfections and infestations16/1547/82
SeizureNervous system disorders12/1547/82
PyrexiaGeneral disorders13/1546/82
HypernatraemiaMetabolism and nutrition disorders4/1546/82
HypokalaemiaMetabolism and nutrition disorders8/1545/82
Urinary retentionRenal and urinary disorders8/1541/82
Deep vein thrombosisVascular disorders5/1544/82

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Artemis + Medical Management (MIS)Best Medical Management Alone (MM)Total
Mean59.6 ± 11.7159.2 ± 12.3359.4 ± 11.90
Sex: Female, Male
Sex: Female, Male(Participants)Artemis + Medical Management (MIS)Best Medical Management Alone (MM)Total
Female553287
Male9950149
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Artemis + Medical Management (MIS)Best Medical Management Alone (MM)Total
Hispanic or Latino22931
Not Hispanic or Latino11561176
Unknown or Not Reported171229
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Artemis + Medical Management (MIS)Best Medical Management Alone (MM)Total
American Indian or Alaska Native101
Asian121123
Black or African American231437
Native Hawaiian or Other Pacific Islander000
White10245147
More Than One Race202
Other314
Unknown145
Not Reported10717
Region of Enrollment
Region of Enrollment(participants)Artemis + Medical Management (MIS)Best Medical Management Alone (MM)Total
Canada213
Austria011
United States14274216
Germany10616
BMI
BMI(kg/m2)Artemis + Medical Management (MIS)Best Medical Management Alone (MM)Total
Mean30.4 ± 8.2130.9 ± 7.2830.6 ± 7.88
08

Study locations

33 sites
  • Abrazo Central
    Phoenix, Arizona 85015, United States
  • UCLA
    Los Angeles, California 90095, United States
  • Mission Hospital
    Mission Viejo, California 92691, United States
  • Swedish - HCA
    Englewood, Colorado 80113, United States
  • Yale University
    New Haven, Connecticut 06510, United States
  • Christiana Health
    Newark, Delaware 19718, United States
  • George Washington
    Washington D.C., District of Columbia 20052, United States
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611, United States
  • Loyola University Chicago
    Chicago, Illinois 60660, United States
  • University of Kentucky
    Lexington, Kentucky 40506, United States
  • University of Louisville
    Louisville, Kentucky 40292, United States
  • Ochsner Medical Center
    New Orleans, Louisiana 70121, United States
  • University of Mississippi
    Jackson, Mississippi 39216, United States
  • University of Missouri
    Columbia, Missouri 65211, United States
  • Atlantic Neuroscience Institute
    Summit, New Jersey 07901, United States
  • Maimonides
    Brooklyn, New York 11219, United States
  • Northwell Health
    Manhasset, New York 11030, United States
  • Mount Sinai
    New York, New York 10029, United States
  • Stony Brook University
    Stony Brook, New York 11794, United States
  • Novant Health
    Charlotte, North Carolina 28277, United States
  • University Hospital Cleveland
    Cleveland, Ohio 44106, United States
  • Geisinger Medical Center
    Danville, Pennsylvania 17822, United States
  • MUSC
    Charleston, South Carolina 29425, United States
  • Methodist University Hospital
    Memphis, Tennessee 38120, United States
  • Valley Baptist Medical Center
    Harlingen, Texas 78520, United States
  • Virginia Mason Medical Center
    Seattle, Washington 98101, United States
  • Harborview Medical Center
    Seattle, Washington 98104, United States
  • Uniklinikum Salzburg
    Salzburg, Austria
  • University of Alberta
    Edmonton, Alberta, Canada
  • Universitätsklinikum Augsburg
    Augsburg, Germany
  • Charité - Universitätsmedizin Berlin
    Berlin, Germany
  • Universitätsklinikum Freiburg
    Freiburg im Breisgau, Germany
  • München Klinik Bogenhausen
    München, Germany
09

References and documents

Publications

  • Arthur AS, Jahromi BS, Saphier PS, Nickele CM, Ryan RW, Vajkoczy P, Schirmer CM, Kellner CP, Matouk CC, Arias EJ, Ullman JS, Levitt MR, Hage ZA, Fiorella DJ; MIND Study Investigators and Collaborators. Minimally Invasive Surgery vs Medical Management Alone for Intracerebral Hemorrhage: The MIND Randomized Clinical Trial. JAMA Neurol. 2025 Nov 1;82(11):1113-1121. doi: 10.1001/jamaneurol.2025.3151. PubMed 40892424 ↗
  • Shiomi Y, Miwa K, Jensen M, Inoue M, Yoshimura S, Kamogawa N, Fukuda-Doi M, Ma H, Ringleb P, Wu O, Schwamm LH, Davis SM, Donnan GA, Gerloff C, Nakahara J, Toyoda K, Thomalla G, Koga M. Efficacy and safety of intravenous alteplase for unknown onset stroke on prior antiplatelet therapy: Post hoc analysis of the EOS individual participant data. Int J Stroke. 2025 Jul;20(6):679-686. doi: 10.1177/17474930251322034. Epub 2025 Feb 27. PubMed 39921231 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Feb 2024, 72 months.

Results were first posted in Jan 2026, 1 year 11 months after primary completion.

Of 84 interventional studies with no phase under Cerebral Hemorrhage, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 72. This study's 72 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2017
First posted
Nov 17, 2017
StartActual
Feb 6, 2018
Primary completionActual
Feb 20, 2024
CompletionActual
Sep 23, 2024
Results first posted
Jan 30, 2026
Last update
Jan 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03342664
Lead sponsor
Penumbra Inc.
Responsible party
Sponsor
First posted
Nov 17, 2017
Start date
Feb 6, 2018
Primary completion
Feb 20, 2024
Completion
Sep 23, 2024
Results posted
Jan 30, 2026
Last update
Jan 30, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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