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

August 21, 2026 updated by: Medtronic Neurovascular Clinical Affairs

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC - Keck School of Medicine
        • Principal Investigator:
          • Kasra Khatibi, MD
        • Contact:
    • Colorado
      • Englewood, Colorado, United States, 80113-2764
        • Recruiting
        • Swedish Medical Center
        • Contact:
        • Principal Investigator:
          • Ian Kaminsky, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale New Haven Hospital
        • Principal Investigator:
          • Charles Matouk, MD
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist Medical Center Jacksonville
        • Principal Investigator:
          • Eric Sauvageau, MD
        • Contact:
          • Smitha Gubbi, MD
          • Phone Number: 904-202-7069
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital
        • Principal Investigator:
          • Maxim Mokin, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60673
      • Park Ridge, Illinois, United States, 60068
        • Suspended
        • Advocate Lutheran General Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46260-1902
        • Recruiting
        • Ascension Saint Vincent Hospital - Indianapolis
        • Contact:
        • Principal Investigator:
          • Daniel H. Sahlein, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
        • Contact:
        • Principal Investigator:
          • Edgar Samaniego, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Aman B. Patel, MD
        • Contact:
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper University Health
        • Principal Investigator:
          • Daniel Tonetti, MD
        • Contact:
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Contact:
          • Alexandra Paul, MD
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Buffalo General Medical Center
        • Contact:
          • Adnan Siddiqui, MD
      • New York, New York, United States, 10029
        • Recruiting
        • The Mount Sinai Hospital
        • Contact:
          • Johanna Fifi, MD
      • Stony Brook, New York, United States, 11794
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • Novant Health Brain and Spine Surgery
        • Contact:
          • Ziad Hage, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Ashutosh Mahapatra, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104-5004
        • Recruiting
        • Oklahoma University Medical Center
        • Principal Investigator:
          • Hakeem Shakir, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Principal Investigator:
          • Pascal Jabbour, MD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15213-2536
        • Recruiting
        • UPMC Presbyterian
        • Principal Investigator:
          • Bradley Gross, MD
        • Contact:
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health
        • Contact:
          • Mohammad Chaudry, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Semmes Murphy Clinic
        • Principal Investigator:
          • Violiza Inoa, MD
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah Hospital
        • Contact:
          • Ramesh Grandhi, MD
    • West Virginia
      • Morgantown, West Virginia, United States, 26506-9260
        • Recruiting
        • West Virginia University
        • Principal Investigator:
          • Ansaar Rai, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Artisse™ Intrasaccular Device
Study subjects with an unruptured or ruptured wide-neck bifurcating intracranial aneurysm will be treated by endovascular implantation of the Artisse™ Intrasaccular Device.
Device: Artisse™ Intrasaccular Device
Intrasaccular Device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effectiveness: Incidence of complete aneurysm occlusion
Time Frame: 1 year post procedure
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.
1 year post procedure
Safety Evaluation
Time Frame: through study completion, an average of 5 years
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.
through study completion, an average of 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of implant success
Time Frame: Procedure
Proportion of subjects with device implant success at the target site
Procedure
Incidence of recurrence
Time Frame: 1 year post procedure
Proportion of subjects with angiographic aneurysmal recurrence at 1 year post-procedure
1 year post procedure
Incidence of adequate aneurysm occlusion
Time Frame: 180 days, 1 year, 3 years, and 5 years post-procedure
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
180 days, 1 year, 3 years, and 5 years post-procedure
Incidence of retreatment
Time Frame: 3 years and 5 years post-procedure
Incidence of retreatment of the target aneurysm through 3 years post-procedure, and 5 years post-procedure
3 years and 5 years post-procedure
Incidence of good clinical outcomes in unruptured intracranial aneurysms (IAs)
Time Frame: 30 days, 180 days, 1 year, 3 years, and 5 years post-procedure
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
30 days, 180 days, 1 year, 3 years, and 5 years post-procedure
Incidence of good clinical outcomes in ruptured intracranial aneurysms (IAs)
Time Frame: 30 days, 180 days, 1 year, 3 years, and 5 years post-procedure
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
30 days, 180 days, 1 year, 3 years, and 5 years post-procedure
Incidence of stroke
Time Frame: 30 days, 180 days, 1 year, 3 years, and 5 years post-procedure
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
30 days, 180 days, 1 year, 3 years, and 5 years post-procedure
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.
Time Frame: 30 days, 180 days, 1 year, 3 years, and 5 years post-procedure
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
30 days, 180 days, 1 year, 3 years, and 5 years post-procedure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedure time
Time Frame: at procedure
Time of guiding catheter entry to the time of guiding catheter removal
at procedure
Radiation Exposure
Time Frame: at procedure
dosage and cumulative fluoroscopy time
at procedure
Incidence of recurrence of the target aneurysm
Time Frame: 1 year post procedure
Web Occlusion Grade C or D at any time after achieving a complete occlusion grade of A immediately post procedure
1 year post procedure
Incidence of retreatment
Time Frame: 1 year post procedure
1 year post procedure
Incidence of aneurysm rupture
Time Frame: 1 year post procedure
1 year post procedure
Incidence of intracranial hemorrhage (excluding target aneurysm)
Time Frame: 1 year post procedure
1 year post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Neurovascular Clinical Affairs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Harsh Sancheti, Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MDT24004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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