A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
195
Device: WEB The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. Other Names: • WEB Aneurysm Embolization Device
Key Effectiveness Outcome
Proportion of subjects with adequate aneurysm occlusion at one year after treatment.
Time frame: 12 Months
Key Safety Outcome
Proportion of subjects with death of any nonaccidental cause or any major stroke\* within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment
Time frame: 12 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Memorial Health Systems
Hollywood, Florida, United States
Orlando Health Neuroscience Institute
Orlando, Florida, United States
The Queen's Medical Center Neuroscience Institute
Honolulu, Hawaii, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Health System
Kansas City, Kansas, United States
Baptist Health Systems
Lexington, Kentucky, United States
University of Kentucky, Department of Neurosurgery
Lexington, Kentucky, United States
Norton Healthcare
Louisville, Kentucky, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
...and 17 more locations