The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracr… (NCT02998229) | Clinical Trial Compass
RecruitingNot Applicable
The Artisseâ„¢ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).
United States300 participantsStarted 2024-04-16
Plain-language summary
The purpose of this study is to assess the safety and effectiveness of the Artisseâ„¢ Intrasaccular Device in the treatment of unruptured and ruptured wide-neck bifurcating intracranial aneurysms.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Effectiveness: Incidence of complete aneurysm occlusion
Timeframe: 1 year post procedure
2
Safety Evaluation
Timeframe: through study completion, an average of 5 years
✕. 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.