Citadel Embolization Device Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Citadel Embolization Device: The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Primary Safety Endpoint is stroke-related neurologic death, or major ipsilateral or disabling stroke in the territory supplied by the treated artery — 12 months post-procedure
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. - Primary Effectiveness Endpoint of this study is adequate aneurysm occlusion without retreatment or significant parent artery stenosis (>50% stenosis). — 12 months post-procedure
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.
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | |
| California Pacific Medical Center | San Francisco | California | |
| UCSF Medical Center | San Francisco | California | |
| John Muir Health | Walnut Creek | California | |
| RIA Neurovascular | Englewood | Colorado | |
| University of Florida | Gainesville | Florida | |
| Baptist Health | Jacksonville | Florida | |
| University of Miami/Jackson Memorial | Miami | Florida | |
| Tampa General Hospital | Tampa | Florida | |
| Northwestern University | Chicago | Illinois | |
| Indiana Methodist | Indianapolis | Indiana | |
| Kansas University Medical Center | Kansas City | Kansas | |
| Baptist Health | Lexington | Kentucky | |
| University of Kentucky | Lexington | Kentucky | |
| UMass Memorial Health | Worcester | Massachusetts | |
| McLaren Health Center | Flint | Michigan | |
| Spectrum Health | Grand Rapids | Michigan | |
| Washington University | St Louis | Missouri | |
| Weill Cornell | New York | New York | |
| Montefiore Medical Center | New York | New York | |
| Cleveland Clinic | Cleveland | Ohio | |
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | |
| Thomas Jefferson University | Philadelphia | Pennsylvania | |
| University of Washington | Seattle | Washington | |
| West Virginia University Hospital | Morgantown | West Virginia |
More Stryker Neurovascular trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04057352 on ClinicalTrials.gov ↗ ← All trials in the USA