New device aims to seal brain aneurysms without open surgery

NCT ID NCT02998229

Disease control Sponsor: Medtronic Neurovascular Clinical Affairs Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 6 times

Summary

This study tests a device called Artisse, which is placed inside a brain aneurysm to block blood flow and prevent rupture. It involves 300 people aged 18-75 with wide-neck aneurysms that are either unruptured or recently ruptured. The main goal is to see if the device safely and effectively seals the aneurysm within one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Artisse™ Intrasaccular Device (a device placed inside the aneurysm to block blood flow)
What this could lead to: If successful, this device could offer a new, less invasive way to treat wide-neck brain aneurysms, potentially reducing the risk of rupture or rebleeding.
What could go wrong: This is an early-stage study with 300 people, so results may not apply to everyone. Risks include stroke, incomplete aneurysm closure, or need for retreatment.

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

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Feb 2032

An estimate. End dates often move.

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 75 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. Subject or subject's Legally Authorized Representative (LAR) has provided written informed consent using the Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent Form (ICF). Health Insurance Portability and Accountability Act (HIPAA)/data protection authorization has been provided and signed by the subject or subject's LAR. 2. Subject is 18-75 years of age at the time of consent. 3. Subject has a single unruptured or ruptured IA requiring treatment. If the patient has an additional IA, the additional IA must not be deemed to require treatment within 1-year of the index procedure. 4. The target aneurysm must have the following characteristics: 1. Saccular morphology 2. Located at a bifurcation in the anterior or posterior circulation 3. Aneurysm Width appropriate for treatment with the Artisse™ Intrasaccular Device for device sizingper the Instructions for Use. 4. Wide-necked, defined as neck size ≥ 4 mm and/or a dome-to-neck ratio of ≥ 1 and \< 2. 5. If the target aneurysm was acutely ruptured, subject must be neurologically stable with Hunt and Hess Grade of I or II. Ruptured IA is defined as showing evidence of SAH attributed to the target aneurysm within the last 30-days (using computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP).) 6. Subject is able to comply with all aspects of the Clinical Investigation Plan (CIP) requirements (e.g., screening, evaluation, treatment, and the post-procedure follow-up schedule). 7. Subject meets one or more risk factors for IA rupture, such as age, hypertension, cigarette smoking, use of sympathomimetic drugs, Japanese or Finnish ancestry, history of prior aneurysmal subarachnoid hemorrhage (aSAH), familial intracranial aneurysms or SAH, clinical or radiological mass effect, reduced quality of life due to fear of rupture, IA size, location, and morphology, documented growth of IA on serial imaging (or enhanced aneurysm walls on contrast), presence of multiple IAs, and presence of concurrent pathology. 8. Treating physician has already selected the subject for endovascular treatment of the target aneurysm after considering risk-benefit of clipping vs endovascular treatment 9. If the subject has an additional IA that was treated previously, the additional IA must have been clinically stable in the past 90 days (i.e. without ongoing adverse events related to the previous treatment). Exclusion Criteria: 1. During treatment planning, it is determined that subject may need an adjunctive implant device in addition to the Artisse™ Intrasaccular Device. (Subjects who need unplanned adjunctive implant devices are not excluded.) 2. Subject's target aneurysm was previously treated with other devices/implants (e.g., coils) or parent artery has a stent or other obstruction that could interfere with the correct placement of the Artisse™ Intrasaccular Device. 3. Subject has a known active systemic bacterial infection. 4. Subject has anatomy or physiology considered unsuitable (e.g., vessel anomaly or disease) for endovascular treatment with the Artisse™ Intrasaccular Device by the treating physician. 5. Subject has a mRS score \> 2 (i.e., mRS scores of 3 to 5) prior to procedure (in case of unruptured IA) or prior to rupture (in case of ruptured IA). 6. Subject has an SAH from a non-target aneurysm or any other intracranial hemorrhage within 90 days. 7. Subject, of child-bearing potential, is pregnant (confirmed with a positive pregnancy test) or plans to become pregnant during the 1 year follow up period after the index procedure. 8. Subject is enrolled in another device or drug study in which participation could confound study results. 9. The treating physician determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, conditions that may increase the chance of stroke) may be compromised by the subject's enrollment. 10. Subject has a known hypersensitivity, which cannot be medically treated, to any component of the study device, procedural materials, or medications commonly used during the procedure. 11. Subject is taking anticoagulants (e.g., warfarin) that cannot be discontinued for a minimum of 7 days post-procedure or have a known blood dyscrasia, coagulopathy, or hemoglobinopathy. 12. Subject has acute or chronic renal failure (unless on dialysis) that would prevent them from undergoing digital subtraction angiography (DSA). 13. Subject has a life expectancy of less than 5 years due to an illness or condition other than the index IA.

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Conditions

The condition(s) this trial relates to.

brain aneurysm

As listed by the trial registrant

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

Intracranial aneurysm

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

25 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Advocate Lutheran General Hospital
SUSPENDED

Park Ridge, Illinois, 60068, United States
Albany Medical Center
RECRUITING

Albany, New York, 12208, United States
Ascension Saint Vincent Hospital - Indianapolis
RECRUITING

Indianapolis, Indiana, 46260-1902, United States
Baptist Medical Center Jacksonville
RECRUITING

Jacksonville, Florida, 32207, United States
Buffalo General Medical Center
RECRUITING

Buffalo, New York, 14203, United States
Cleveland Clinic Foundation
RECRUITING

Cleveland, Ohio, 44195, United States
Cooper University Health
RECRUITING

Camden, New Jersey, 08103, United States
Hospital of the University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Novant Health Brain and Spine Surgery
RECRUITING

Charlotte, North Carolina, 28211, United States
Oklahoma University Medical Center
RECRUITING

Oklahoma City, Oklahoma, 73104-5004, United States
Prisma Health
RECRUITING

Greenville, South Carolina, 29605, United States
Semmes Murphy Clinic
RECRUITING

Memphis, Tennessee, 38120, United States
Stony Brook University Hospital
RECRUITING

Stony Brook, New York, 11794, United States
Swedish Medical Center
RECRUITING

Englewood, Colorado, 80113-2764, United States
Tampa General Hospital
RECRUITING

Tampa, Florida, 33606, United States
The Mount Sinai Hospital
RECRUITING

New York, New York, 10029, United States
Thomas Jefferson University Hospital
RECRUITING

Philadelphia, Pennsylvania, 19107, United States
UPMC Presbyterian
RECRUITING

Pittsburgh, Pennsylvania, 15213-2536, United States
USC - Keck School of Medicine
RECRUITING

Los Angeles, California, 90033, United States
University of Chicago
RECRUITING

Chicago, Illinois, 60673, United States
University of Iowa Hospitals and Clinics
RECRUITING

Iowa City, Iowa, 52242, United States
University of Utah Hospital
RECRUITING

Salt Lake City, Utah, 84132, United States
West Virginia University
RECRUITING

Morgantown, West Virginia, 26506-9260, United States
Yale New Haven Hospital
RECRUITING

New Haven, Connecticut, 06519, United States

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