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Intracranial AneurysmARTISSENCT02998229

The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).

A study testing Artisse™ Intrasaccular Device in people with Intracranial Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 25 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to assess the safety and effectiveness of the Artisse™ Intrasaccular Device in the treatment of unruptured and ruptured wide-neck bifurcating intracranial aneurysms. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Intracranial Aneurysm
What is being tested?
Artisse™ Intrasaccular Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
25 sitesUnited States
Study dates
16 Apr 2024to Feb 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Subject is 18-75 years of age at the time of consent.
  • 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.
  • The target aneurysm must have the following characteristics:
  • Saccular morphology
  • Located at a bifurcation in the anterior or posterior circulation
Show all 14Show fewer
  • Aneurysm Width appropriate for treatment with the Artisse™ Intrasaccular Device for device sizingper the Instructions for Use.
  • Wide-necked, defined as neck size ≥ 4 mm and/or a dome-to-neck ratio of ≥ 1 and < 2.
  • 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).)
  • 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).
  • 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.
  • Treating physician has already selected the subject for endovascular treatment of the target aneurysm after considering risk-benefit of clipping vs endovascular treatment
  • 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).

Who cannot join

  • 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.)
  • 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.
  • Subject has a known active systemic bacterial infection.
  • 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.
  • 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).
  • Subject has an SAH from a non-target aneurysm or any other intracranial hemorrhage within 90 days.
Show all 13Show fewer
  • 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.
  • Subject is enrolled in another device or drug study in which participation could confound study results.
  • 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.
  • 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.
  • 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.
  • Subject has acute or chronic renal failure (unless on dialysis) that would prevent them from undergoing digital subtraction angiography (DSA).
  • Subject has a life expectancy of less than 5 years due to an illness or condition other than the index IA.

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Medtronic Neurovascular Clinical Affairs contact

949-837-3700

rs.nvclinicalartisse@medtronic.com

25 sites in 1 country

United States25 sites, 25 recruiting

  • Albany Medical Center

    Albany, New York, 12208

    Alexandra Paul, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Shayna Hollander, 617-643-5547, sdhollander@mgh.harvard.edu

    Aman B. Patel, MD

    Recruiting

  • Buffalo General Medical Center

    Buffalo, New York, 14203

    Adnan Siddiqui, MD

    Recruiting

  • Cooper University Health

    Camden, New Jersey, 08103

    Thuy Van Cao, 856-342-2362, cao-thuy@cooperhealth.edu

    Daniel Tonetti, MD

    Recruiting

  • Novant Health Brain and Spine Surgery

    Charlotte, North Carolina, 28211

    Ziad Hage, MD

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60673

    Khalid Trad, khalid.trad@bsd.uchicago.edu

    Tareq Kass-Hout, MD

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Heidi Poppendeck, poppenh@ccf.org

    Ashutosh Mahapatra, MD

    Recruiting

  • Swedish Medical Center

    Englewood, Colorado, 80113-2764

    Ashley Thompson, 303-907-5634, ashley.thompson3@hcahealthcare.com

    Ian Kaminsky, MD

    Recruiting

  • Prisma Health

    Greenville, South Carolina, 29605

    Mohammad Chaudry, MD

    Recruiting

  • Ascension Saint Vincent Hospital - Indianapolis

    Indianapolis, Indiana, 46260-1902

    Luke Watkins, lwatkins@goodmancampbell.com

    Daniel H. Sahlein, MD

    Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

    Heena Olalde, 319-356-8326, heena-olalde@uiowa.edu

    Edgar Samaniego, MD

    Recruiting

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida, 32207

    Smitha Gubbi, MD, 904-202-7069

    Eric Sauvageau, MD

    Recruiting

  • USC - Keck School of Medicine

    Los Angeles, California, 90033

    Kelly Hu, 323-442-0661, Kelly.Hu@med.usc.edu

    Kasra Khatibi, MD

    Recruiting

  • Semmes Murphy Clinic

    Memphis, Tennessee, 38120

    Wendell Barnett, 901-260-6124, wbarnett@semmes-murphey.com

    Violiza Inoa, MD

    Recruiting

  • West Virginia University

    Morgantown, West Virginia, 26506-9260

    Jennifer Domico, 304-598-6930, jennifer.domico@wvumedicine.org

    Ansaar Rai, MD

    Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut, 06519

    Lindsey Fraczkiewicz, lindsey.fraczkiewicz@yale.edu

    Charles Matouk, MD

    Recruiting

  • The Mount Sinai Hospital

    New York, New York, 10029

    Johanna Fifi, MD

    Recruiting

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104-5004

    Katarzyna Zyla-Jackson, katarzyna-zyla@ou.edu

    Hakeem Shakir, MD

    Recruiting

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

    Victor Arroyo, 847-723-7950, victor.arroyo@aah.org

    Joshua Billingsley, MD

    Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Christopher Boivin, christopher.boivin@pennmedicine.upenn.edu

    Jan-Karl Burkhardt, MD

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Nico Agosti, nico.agosti@jefferson.edu

    Pascal Jabbour, MD

    Recruiting

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213-2536

    Lauren Puccio, pucciolm@upmc.edu

    Bradley Gross, MD

    Recruiting

  • University of Utah Hospital

    Salt Lake City, Utah, 84132

    Ramesh Grandhi, MD

    Recruiting

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

    Marlene Baumeister, 631-444-1610, marlene.baumeister@stonybrookmedicine.edu

    David Fiorella, MD

    Recruiting

  • Tampa General Hospital

    Tampa, Florida, 33606

    Muni Sai Bachalakuri, 813-844-8498, mbachalakuri@tgh.org

    Maxim Mokin, MD

    Recruiting

Other trials in United States

About this study

Official title: Artisse™ Intrasaccular Device IDE

The purpose of this study is to assess the safety and effectiveness of the Artisse™ Intrasaccular Device in the treatment of unruptured and ruptured wide-neck bifurcating intracranial aneurysms.

Read the detailed description

The Artisse™ IDE study is a prospective, multi-center, single-arm Investigational Device Exemption (IDE) study of the Artisse™ Intrasaccular Device for the treatment of IAs. The primary objective of the Artisse™ IDE study is to assess the safety and effectiveness of the Artisse™ Intrasaccular Device in the treatment of unruptured and ruptured wide-neck bifurcating intracranial aneurysms. The effectiveness of the Artisse™ Intrasaccular Device is measured by its ability to completely occlude the treated aneurysm without retreatment of the target aneurysm, recurrent subarachnoid hemorrhage from the target aneurysm, or significant parent artery stenosis (> 50% stenosis) at 1 year post-procedure.

Being tested
Artisse™ Intrasaccular Device
Keywords
Intracranial aneurysm, Intrasaccular, Artisse
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artisse™ Intrasaccular DeviceDevice

    Intrasaccular Device

Study groups in NCT02998229
Study groupRoleWhat they receive
Artisse™ Intrasaccular DeviceExperimentalStudy subjects with an unruptured or ruptured wide-neck bifurcating intracranial aneurysm will be treated by endovascular implantation of the Artisse™ Intrasaccular Device.
Receives: Device: Artisse™ Intrasaccular Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness: Incidence of complete aneurysm occlusion

    Incidence of complete aneurysm occlusion without retreatment of the target aneurysm, recurrent subarachnoid hemorrhage (SAH) from the target aneurysm, or significant parent artery stenosis (>50% stenosis) at 1 year post-procedure.

    Measured: 1 year post procedure

  2. Safety Evaluation

    The safety of the Artisse™ Intrasaccular Device will be determined based on a review of all the serious adverse events (SAEs) observed during the study.

    Measured: through study completion, an average of 5 years

Secondary outcomes (8)

  1. Incidence of implant success

    Proportion of subjects with device implant success at the target site

    Measured: Procedure

  2. Incidence of recurrence

    Proportion of subjects with angiographic aneurysmal recurrence at 1 year post-procedure

    Measured: 1 year post procedure

  3. Incidence of stroke

    Proportion of subjects experiencing a stroke (ischemic or hemorrhagic) within 30 days post-procedure, 180 days post-procedure, 1 year post-procedure, 3 years post-procedure, and 5 years post-procedure

    Measured: 30 days, 180 days, 1 year, 3 years, and 5 years post-procedure

  4. Change in Modified Rankin Score (mRS) compared to baseline. mRS scores can range from 0 (no symptoms) to 5 (severe disability) with a separate category of 6 added for patients who expire.

    Proportion of subjects with unruptured intracranial aneurysms (IAs) experiencing improvement, deterioration, or no change in the mRS score compared to baseline through 30 days post-procedure, 180 days post procedure, 1 year post-procedure, 3 years post-procedure, and 5 years post-procedure

    Measured: 30 days, 180 days, 1 year, 3 years, and 5 years post-procedure

  5. Incidence of good clinical outcomes in unruptured intracranial aneurysms (IAs)

    Proportion of subjects with unruptured IAs experiencing good clinical outcomes, defined as an Modified Rankin Score (mRS) score of 0-2 (0: No symptoms, 1: No significant disability despite symptoms, 3: Slight disability) through 30 days post-procedure, 180 days post-procedure, 1 year post-procedure, 3 years post-procedure, and 5 years post-procedure

    Measured: 30 days, 180 days, 1 year, 3 years, and 5 years post-procedure

  6. Incidence of good clinical outcomes in ruptured intracranial aneurysms (IAs)

    Proportion of subjects with ruptured IAs experiencing good clinical outcomes, defined as an Modified Rankin Score (mRS) score of 0-2 (0: No symptoms, 1: No significant disability despite symptoms, 3: Slight disability) through 30 days post-procedure, 180 days post-procedure, 1 year post-procedure, 3 years post-procedure, and 5 years post-procedure

    Measured: 30 days, 180 days, 1 year, 3 years, and 5 years post-procedure

  7. Incidence of adequate aneurysm occlusion

    Incidence of adequate aneurysm occlusion of the target aneurysm at 180 days post-procedure, 1 year post-procedure, 3 years post-procedure, and 5 years post-procedure

    Measured: 180 days, 1 year, 3 years, and 5 years post-procedure

  8. Incidence of retreatment

    Incidence of retreatment of the target aneurysm through 3 years post-procedure, and 5 years post-procedure

    Measured: 3 years and 5 years post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2016 (estimated)
  2. Study start16 Apr 2024
  3. Primary completionAug 2027 (estimated)
  4. Study completionFeb 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02998229
Sponsor's protocol ID
MDT24004
Acronym
ARTISSE
Status last verified
Aug 2026
First submitted
16 Dec 2016
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Artisse™ Intrasaccular Device in people with Intracranial Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Medtronic Neurovascular Clinical Affairs (949-837-3700, rs.nvclinicalartisse@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness: Incidence of complete aneurysm occlusion (time frame: 1 year post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02998229.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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