The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).
NCT ID: NCT02998229
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
220 participants
INTERVENTIONAL
2024-04-16
2032-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Artisse™ Intrasaccular Device
Intrasaccular Device
Interventions
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Artisse™ Intrasaccular Device
Intrasaccular Device
Eligibility Criteria
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Inclusion Criteria
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 per the Instructions for Use, between 3.4 mm and 6.0 mm.
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, 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
Exclusion Criteria
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 breastfeeding at the time of admission or plans to become pregnant during their participation in the study.
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.
18 Years
75 Years
ALL
No
Sponsors
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Medtronic Neurovascular Clinical Affairs
INDUSTRY
Responsible Party
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Principal Investigators
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Harsh Sancheti
Role: STUDY_DIRECTOR
Medtronic
Locations
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Baptist Medical Center Jacksonville
Jacksonville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
University of Chicago
Chicago, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Albany Medical Center
Albany, New York, United States
Buffalo General Medical Center
Buffalo, New York, United States
The Mount Sinai Hospital
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Novant Health Brain and Spine Surgery
Charlotte, North Carolina, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Prisma Health
Greenville, South Carolina, United States
Semmes Murphy Clinic
Memphis, Tennessee, United States
University of Utah Hospital
Salt Lake City, Utah, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Smitha Gubbi, MD
Role: primary
Muni Sai Bachalakuri
Role: primary
Khalid Trad
Role: primary
Victor Arroyo
Role: primary
Heena Olalde
Role: primary
Alexandra Paul, MD
Role: primary
Adnan Siddiqui, MD
Role: primary
Johanna Fifi, MD
Role: primary
Marlene Baumeister
Role: primary
Ziad Hage, MD
Role: primary
Christopher Boivin
Role: primary
Nico Agosti
Role: primary
Mohammad Chaudry, MD
Role: primary
Wendell Barnett
Role: primary
Ramesh Grandhi, MD
Role: primary
Jennifer Domico
Role: primary
Other Identifiers
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MDT24004
Identifier Type: -
Identifier Source: org_study_id