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Artisse™ Intrasaccular Device IDE — ARTISSE  

Intracranial Aneurysm Clinical Trial

Official title:
Artisse™ Intrasaccular Device IDE

Clinical Trial 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.

Clinical Trial 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 the target aneurysm, or significant parent artery stenosis (> 50% stenosis) at 1 year post-procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02998229
Study type Interventional
Source Medtronic Neurovascular Clinical Affairs
Contact Medtronic Neurovascular Clinical Affairs
Phone 949-837-3700
Email rs.nvclinicalartisse@medtronic.com
Status Recruiting
Phase N/A
Start date April 16, 2024
Completion date February 2032
View Details
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