RecruitingIntracranial Aneurysm

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

Eligible age

18–75 yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

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About this study

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.

Sponsor: Medtronic Neurovascular Clinical Affairs

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.