Actively Recruiting
The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).
Led by Medtronic Neurovascular Clinical Affairs · Updated on 2026-05-05
300
Participants Needed
22
Research Sites
406 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject or legally authorized representative has signed informed consent and data protection authorization.
- Age between 18 and 75 years at the time of consent.
- Single unruptured or ruptured intracranial aneurysm requiring treatment.
- Target aneurysm has saccular shape and is located at a bifurcation in anterior or posterior circulation.
- Aneurysm size suitable for treatment with the Artisse22 Intrasaccular Device per instructions.
- Wide-neck aneurysm defined as neck size 63 4 mm and/or dome-to-neck ratio between 1 and less than 2.
- Neurologically stable if aneurysm was acutely ruptured, with Hunt and Hess Grade I or II.
- Ability to comply with study procedures and follow-up schedule.
- Presence of one or more risk factors for aneurysm rupture.
- Selected for endovascular treatment after weighing risks and benefits.
- Previously treated additional aneurysms must have been stable for at least 90 days.
You will not qualify if you...
- Need for adjunctive implant device planned during treatment.
- Target aneurysm previously treated with devices like coils or parent artery has stent or obstruction.
- Known active systemic bacterial infection.
- Anatomy or physiology unsuitable for endovascular treatment.
- Modified Rankin Scale score greater than 2 before procedure or rupture.
- Subarachnoid hemorrhage from non-target aneurysm or other brain bleeding within 90 days.
- Pregnancy or plans to become pregnant during 1-year follow-up.
- Enrollment in another device or drug study that may affect results.
- Health condition or risk factors that could compromise safety or study validity.
- Known untreated hypersensitivity to device components or procedural materials.
- Use of anticoagulants that cannot be stopped for at least 7 days after procedure or known blood disorders.
- Acute or chronic kidney failure preventing imaging unless on dialysis.
- Life expectancy less than 5 years due to illness other than the target aneurysm.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Swedish Medical Center
Englewood, Colorado, United States, 80113-2764
Actively Recruiting
2
Yale New Haven Hospital
New Haven, Connecticut, United States, 06519
Actively Recruiting
3
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
4
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
5
University of Chicago
Chicago, Illinois, United States, 60673
Actively Recruiting
6
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
Actively Recruiting
7
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
Cooper University Health
Camden, New Jersey, United States, 08103
Actively Recruiting
10
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
11
Buffalo General Medical Center
Buffalo, New York, United States, 14203
Actively Recruiting
12
The Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
13
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Actively Recruiting
14
Novant Health Brain and Spine Surgery
Charlotte, North Carolina, United States, 28211
Actively Recruiting
15
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
16
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
17
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
18
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213-2536
Actively Recruiting
19
Prisma Health
Greenville, South Carolina, United States, 29605
Actively Recruiting
20
Semmes Murphy Clinic
Memphis, Tennessee, United States, 38120
Actively Recruiting
21
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
Actively Recruiting
22
West Virginia University
Morgantown, West Virginia, United States, 26506-9260
Actively Recruiting
Research Team
M
Medtronic Neurovascular Clinical Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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