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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Intrasaccular Device
Yale New Haven Hospital
New Haven, Connecticut, United States
RECRUITINGEffectiveness: Incidence of complete aneurysm occlusion
Incidence of complete aneurysm occlusion without retreatment of the target aneurysm, recurrent subarachnoid hemorrhage (SAH) from the target aneurysm, or significant parent artery stenosis (\>50% stenosis) at 1 year post-procedure.
Time frame: 1 year post procedure
Safety Evaluation
The safety of the Artisse™ Intrasaccular Device will be determined based on a review of all the serious adverse events (SAEs) observed during the study.
Time frame: through study completion, an average of 5 years
Incidence of implant success
Proportion of subjects with device implant success at the target site
Time frame: Procedure
Incidence of recurrence
Proportion of subjects with angiographic aneurysmal recurrence at 1 year post-procedure
Time frame: 1 year post procedure
Incidence of stroke
Proportion of subjects experiencing a stroke (ischemic or hemorrhagic) within 30 days post-procedure, 180 days post-procedure, 1 year post-procedure, 3 years post-procedure, and 5 years post-procedure
Time frame: 30 days, 180 days, 1 year, 3 years, and 5 years post-procedure
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.
Proportion of subjects with unruptured intracranial aneurysms (IAs) experiencing improvement, deterioration, or no change in the mRS score compared to baseline through 30 days post-procedure, 180 days post procedure, 1 year post-procedure, 3 years post-procedure, and 5 years post-procedure
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Baptist Medical Center Jacksonville
Jacksonville, Florida, United States
RECRUITINGTampa General Hospital
Tampa, Florida, United States
RECRUITINGUniversity of Chicago
Chicago, Illinois, United States
RECRUITINGAdvocate Lutheran General Hospital
Park Ridge, Illinois, United States
RECRUITINGUniversity of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
RECRUITINGAlbany Medical Center
Albany, New York, United States
RECRUITINGBuffalo General Medical Center
Buffalo, New York, United States
RECRUITINGThe Mount Sinai Hospital
New York, New York, United States
RECRUITINGStony Brook University Hospital
Stony Brook, New York, United States
RECRUITING...and 8 more locations
Time frame: 30 days, 180 days, 1 year, 3 years, and 5 years post-procedure
Incidence of good clinical outcomes in unruptured intracranial aneurysms (IAs)
Proportion of subjects with unruptured IAs experiencing good clinical outcomes, defined as an Modified Rankin Score (mRS) score of 0-2 (0: No symptoms, 1: No significant disability despite symptoms, 3: Slight disability) through 30 days post-procedure, 180 days post-procedure, 1 year post-procedure, 3 years post-procedure, and 5 years post-procedure
Time frame: 30 days, 180 days, 1 year, 3 years, and 5 years post-procedure
Incidence of good clinical outcomes in ruptured intracranial aneurysms (IAs)
Proportion of subjects with ruptured IAs experiencing good clinical outcomes, defined as an Modified Rankin Score (mRS) score of 0-2 (0: No symptoms, 1: No significant disability despite symptoms, 3: Slight disability) through 30 days post-procedure, 180 days post-procedure, 1 year post-procedure, 3 years post-procedure, and 5 years post-procedure
Time frame: 30 days, 180 days, 1 year, 3 years, and 5 years post-procedure
Incidence of adequate aneurysm occlusion
Incidence of adequate aneurysm occlusion of the target aneurysm at 180 days post-procedure, 1 year post-procedure, 3 years post-procedure, and 5 years post-procedure
Time frame: 180 days, 1 year, 3 years, and 5 years post-procedure
Incidence of retreatment
Incidence of retreatment of the target aneurysm through 3 years post-procedure, and 5 years post-procedure
Time frame: 3 years and 5 years post-procedure