NCT02998229

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

Artisse™ Intrasaccular Device IDE

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Medtronic Neurovascular Clinical Affairs · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	Artisse™ Intrasaccular Device	Intrasaccular Device

Timeline

• Start date: 2024-04-16
• Primary completion: 2027-08-01
• Completion: 2032-02-01
• First posted: 2016-12-20
• Last updated: 2026-03-17

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated device study