Artisse™ Intrasaccular Device IDE
Medtronic Neurovascular Clinical Affairs
Summary
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.
Description
The Artisse™ IDE study is a prospective, multi-center, single-arm Investigational Device Exemption (IDE) study of the Artisse™ Intrasaccular Device for the treatment of IAs. The primary objective of the Artisse™ IDE 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. The effectiveness of the Artisse™ Intrasaccular Device is measured by its ability to completely occlude the treated aneurysm without retreatment of the target aneurysm, recurrent subarachnoid hemorrhage from t…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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 w…
Interventions
- DeviceArtisse™ Intrasaccular Device
Intrasaccular Device
Locations (22)
- Swedish Medical CenterEnglewood, Colorado
- Yale New Haven HospitalNew Haven, Connecticut
- Baptist Medical Center JacksonvilleJacksonville, Florida
- Tampa General HospitalTampa, Florida
- University of ChicagoChicago, Illinois
- Advocate Lutheran General HospitalPark Ridge, Illinois