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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citadel Embolization Device | Other | The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citadel Embolization Device | Device | The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)
| 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. | 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ansaar Rai, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| California Pacific Medical Center |
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| 12 months post-procedure |
| San Francisco |
| California |
| 94114 |
| United States |
| UCSF Medical Center | San Francisco | California | 94143 | United States |
| John Muir Health | Walnut Creek | California | 94598 | United States |
| RIA Neurovascular | Englewood | Colorado | 80113 | United States |
| University of Florida | Gainesville | Florida | 32608 | United States |
| Baptist Health | Jacksonville | Florida | 32207 | United States |
| University of Miami/Jackson Memorial | Miami | Florida | 33136 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Indiana Methodist | Indianapolis | Indiana | 46202 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| Baptist Health | Lexington | Kentucky | 40503 | United States |
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
| UMass Memorial Health | Worcester | Massachusetts | 01605 | United States |
| McLaren Health Center | Flint | Michigan | 48532 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Weill Cornell | New York | New York | 10021 | United States |
| Montefiore Medical Center | New York | New York | 10467 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | United States |