Aneurysm Treatment Using Intrasaccular Flow Diversion With the ARTISSE™ Device

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and effectiveness of the Artisse™ Intrasaccular Device in the treatment of bifurcating saccular intracranial aneurysms.

Official Title
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ARTISSE Aneurysm Treatment Using Intrasaccular Flow Diversion With the ARTISSE™ Device

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Device: Artisse™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements. Subject is at least 22 years old at the time of consent. Subject has a ruptured or unruptured, wide neck, bifurcating saccular intracranial aneurysm (IA) requiring endovascular treatment. Exclusion Criteria: Subject has more than one aneurysm requiring treatment. Subject underwent treatment of another aneurysm inside the affected territory of the target aneurysm. Aneurysm is partially thrombosed. Aneurysm has been previously treated with surgery or endovascular therapy, or there is a stent or other obstruction in the parent artery at the target aneurysm location. Subject has had subarachnoid hemorrhage (SAH) from non target aneurysm or any other intracranial hemorrhage within 90 days prior to study procedure. Subject vessel has characteristics that preclude safe endovascular access. Subject has active vasospasm, malignant brain tumor or vascular malformation (e.g. arteriovascular malformation). Subject has had major surgery including endovascular procedures within the past 30 days prior to study procedure. Subject has a life expectancy of < 12 months. The Investigator 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 is pregnant or wishes to become pregnant during the length of study participation. Subject is participating in another clinical trial at any time during the duration of the study that could confound the treatment or outcomes of this investigation. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from Medtronic.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artisse™ Intrasaccular Device<br> | Device: Artisse™<br>* Intrasaccular Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complete aneurysm occlusion without retreatment, recurrent SAH, and without significant parent artery stenosis | Significant parent artery stenosis defined as stenosis of the parent artery associated with stroke or total occlusion of the artery | 1 year post procedure | 
| Incidence of major stroke or neurological death |  | 1 year post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of successful device implantation |  | Implant | 
| Incidence of adequate aneurysm occlusion |  | 1 year post procedure | 
| Incidence of unruptured aneurysm subjects with modified Rankin Score (mRS) of 0-2 or no increase in the mRS |  | 1 year post procedure | 
| Incidence of major stroke in the territory supplied by the treated artery or neurological death |  | 30 days post procedure |