The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).
Start Date
4/16/2024
Completion Date
2/1/2032
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.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
Artisse™ Intrasaccular Device
Conditions
Locations
Swedish Medical Center
Englewood, Colorado 80113-2764
United States
Yale New Haven Hospital
New Haven, Connecticut 06519
United States
Baptist Medical Center Jacksonville
Jacksonville, Florida 32207
United States
Tampa General Hospital
Tampa, Florida 33606
United States
University of Chicago
Chicago, Illinois 60673
United States
Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
United States
Ascension Saint Vincent Hospital - Indianapolis
Indianapolis, Indiana 46260-1902
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Cooper University Health
Camden, New Jersey 08103
United States
Albany Medical Center
Albany, New York 12208
United States
Buffalo General Medical Center
Buffalo, New York 14203
United States
The Mount Sinai Hospital
New York, New York 10029
United States
Stony Brook University Hospital
Stony Brook, New York 11794
United States
Novant Health Brain and Spine Surgery
Charlotte, North Carolina 28211
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
UPMC Presbyterian
Pittsburgh, Pennsylvania 15213-2536
United States
Prisma Health
Greenville, South Carolina 29605
United States
Semmes Murphy Clinic
Memphis, Tennessee 38120
United States
University of Utah Hospital
Salt Lake City, Utah 84132
United States
West Virginia University
Morgantown, West Virginia 26506-9260
United States