The purpose of this study is to gather safety and effectiveness data on Stryker Neurovascular's Next Generation Target Detachable Coil (hereafter referred to as the Citadel Embolization Device), when used with Target Detachable Coils, in the treatment of wide-neck intracranial aneurysms.
In this study, use of the Citadel Embolization Device will be limited to a population of patients with unruptured or ruptured wide-neck aneurysms who meet all study eligibility criteria. The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.
Cedars-Sinai Medical Center
Los Angeles, California, United States
Primary Safety Endpoint is stroke-related neurologic death, or major ipsilateral or disabling stroke in the territory supplied by the treated artery
Occurring within 12 months post-procedure as adjudicated by an independent Clinical Events Committee (CEC) * With major ipsilateral stroke defined as a stroke associated with an increase in NIHSS score ≥ 4 points persisting ≥ 24 hours, and; * With disabling stroke defined as a stroke that results in a modified Rankin Scale (mRS) score ≥ 3 assessed at a minimum of 90 days post-stroke event.
Time frame: 12 months post-procedure
Primary Effectiveness Endpoint of this study is adequate aneurysm occlusion without retreatment or significant parent artery stenosis (>50% stenosis).
The determination of adequate aneurysm occlusion using Raymond-Roy classification will be made if either of the following criteria in the description are met: -100% occlusion (Raymond Class I) demonstrated by Digital Subtraction Angiography (DSA) measurement at 12 months (± 3 months) post-procedure, or -Stable Raymond class II demonstrated on 2 serial imaging measurements using Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) and/or DSA obtained a minimum of 6 months (± 1 month) apart. Post-procedure and 12-month imaging must be completed with DSA.
Time frame: 12 months post-procedure
Secondary Safety Endpoint of this study is any stroke event occurring through 12 months post-procedure, where a stroke event is defined as per what is noted in the description.
-Rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours with no apparent cause other than of vascular origin, including ischemic stroke and/or hemorrhagic stroke (i.e., intraparenchymal hemorrhage \[IPH\], subarachnoid hemorrhage \[SAH\], subdural hemorrhage \[SDH\], epidural hemorrhage \[EDH\]) accompanied with radiological evidence.
Time frame: 12 months post-procedure
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California Pacific Medical Center
San Francisco, California, United States
UCSF Medical Center
San Francisco, California, United States
John Muir Health
Walnut Creek, California, United States
RIA Neurovascular
Englewood, Colorado, United States
University of Florida
Gainesville, Florida, United States
Baptist Health
Jacksonville, Florida, United States
University of Miami/Jackson Memorial
Miami, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
...and 15 more locations