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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years and 5 years post-procedure

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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