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Flow Diversion Device

Artisse™ Device for Brain Aneurysms (ARTISSE Trial)

N/A
Recruiting
Research Sponsored by Medtronic Neurovascular Clinical Affairs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years and 5 years post-procedure
Awards & highlights

Summary

This trial aims to determine if the Artisse™ Intrasaccular Device is safe and effective in treating both unruptured and ruptured wide-neck bifurcating intracranial aneur

Who is the study for?
This trial is for adults over the age of 22 with a specific type of brain aneurysm that has not burst (unruptured) or has burst (ruptured). The aneurysms should be wide-necked and located at a point where two blood vessels split. Participants must agree to follow the study rules and provide written consent.
What is being tested?
The Artisse™ Intrasaccular Device, which is placed inside the aneurysm during a minimally invasive procedure, is being tested for its ability to safely and effectively treat brain aneurysms without requiring open surgery.
What are the potential side effects?
While specific side effects are not listed here, similar procedures may include risks such as reaction to materials, bleeding in the brain, stroke-like symptoms due to vessel blockage or narrowing, and infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years and 5 years post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years and 5 years post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effectiveness: Incidence of complete aneurysm occlusion
Safety: incidence of stroke
Secondary study objectives
Change in Modified Rankin Score (mRS) compared to baseline. mRS scores can range from 0 (no symptoms) to 5 (severe disability) with a separate category of 6 added for patients who expire.
Incidence of adequate aneurysm occlusion
Incidence of good clinical outcomes in ruptured intracranial aneurysms (IAs)
+5 more
Other study objectives
Incidence of aneurysm rupture
Incidence of intracranial hemorrhage (excluding target aneurysm)
Incidence of recurrence of the target aneurysm
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Artisse™ Intrasaccular DeviceExperimental Treatment1 Intervention
Study subjects with an unruptured or ruptured wide-neck bifurcating intracranial aneurysm will be treated by endovascular implantation of the Artisse™ Intrasaccular Device.

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Who is running the clinical trial?

Medtronic Neurovascular Clinical AffairsLead Sponsor
30 Previous Clinical Trials
9,461 Total Patients Enrolled
~147 spots leftby Feb 2028
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