RecruitingNot ApplicableNCT02998229
The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).
Artisse™ Intrasaccular Device IDE
Sponsor
Medtronic Neurovascular Clinical Affairs
Enrollment
300 participants
Start Date
Apr 16, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Plain Language Summary
Simplified for easier understanding
This study evaluates the Artisse intrasaccular device — a small implant placed inside a brain aneurysm to block blood flow and prevent rupture — for the treatment of wide-neck bifurcation aneurysms (balloon-like bulges at forks in brain arteries). The goal is to confirm its safety and effectiveness in real-world use.
You may be eligible if:
- You are between 18 and 75 years old
- You have a single brain aneurysm (ruptured or unruptured) requiring treatment
- The aneurysm is saccular (balloon-shaped), located at a bifurcation, and has a wide neck
- If ruptured, you are neurologically stable (Hunt and Hess Grade I or II)
- You have one or more risk factors for aneurysm rupture
You may NOT be eligible if:
- Your aneurysm was previously treated with coils or stents
- You have an active bacterial infection
- You are pregnant or plan to become pregnant within 1 year of the procedure
- You have kidney failure (unless on dialysis)
- You have a life expectancy of less than 5 years from a separate illness
- You are on anticoagulants that cannot be stopped
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DEVICEArtisse™ Intrasaccular Device
Intrasaccular Device
Locations(22)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02998229
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