The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).
ARTISSE
Artisse™ Intrasaccular Device IDE
1 other identifier
interventional
300
1 country
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2016
CompletedFirst Posted
Study publicly available on registry
December 20, 2016
CompletedStudy Start
First participant enrolled
April 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2032
May 5, 2026
February 1, 2026
3.3 years
December 16, 2016
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
1 year post procedure
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.
through study completion, an average of 5 years
Secondary Outcomes (8)
Incidence of implant success
Procedure
Incidence of recurrence
1 year post procedure
Incidence of stroke
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.
30 days, 180 days, 1 year, 3 years, and 5 years post-procedure
Incidence of good clinical outcomes in unruptured intracranial aneurysms (IAs)
30 days, 180 days, 1 year, 3 years, and 5 years post-procedure
- +3 more secondary outcomes
Study Arms (1)
Artisse™ Intrasaccular Device
EXPERIMENTALStudy subjects with an unruptured or ruptured wide-neck bifurcating intracranial aneurysm will be treated by endovascular implantation of the Artisse™ Intrasaccular Device.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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).
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Swedish Medical Center
Englewood, Colorado, 80113-2764, United States
Yale New Haven Hospital
New Haven, Connecticut, 06519, United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, 32207, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
University of Chicago
Chicago, Illinois, 60673, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Cooper University Health
Camden, New Jersey, 08103, United States
Albany Medical Center
Albany, New York, 12208, United States
Buffalo General Medical Center
Buffalo, New York, 14203, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Novant Health Brain and Spine Surgery
Charlotte, North Carolina, 28211, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213-2536, United States
Prisma Health
Greenville, South Carolina, 29605, United States
Semmes Murphy Clinic
Memphis, Tennessee, 38120, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
West Virginia University
Morgantown, West Virginia, 26506-9260, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Harsh Sancheti
Medtronic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2016
First Posted
December 20, 2016
Study Start
April 16, 2024
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
February 1, 2032
Last Updated
May 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share