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Active, not recruiting Not applicable

Citadel Embolization Device Study

NCT04057352 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2019-07-18
Last updated
2026-03-30

Condition(s) studied

Unruptured Wide-neck Aneurysms

Investigational drug(s) / intervention(s)

Citadel Embolization Device

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age is ≥18 and ≤80 years 2. Has a single, unruptured or ruptured target intracranial aneurysm that is suitable for endovascular treatment. Definition: For the purposes of this study, a ruptured intracranial aneurysm is defined as one with CT/MRI/LP evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 60 days. 3. Aneurysm morphology is saccular 4. Aneurysm size is between 6-12 mm 5. Has a wide-neck, saccular aneurysm, either bifurcation or sidewall, with a dome to neck ratio \<2 or neck ≥4 mm 6. If the target intracranial aneurysm is classified as ruptured, patient must be neurologically stable with a Hunt \& Hess Score of 1 or 2. 7. Must be willing to comply with protocol required procedures and follow up 8. Subject or LAR must be willing to sign and date an IRB approved written informed consent prior to initiation of any screening or study procedures Exclusion Criteria: 1. Target aneurysm has been previously treated 2. Target aneurysm is in any extradural location, including the extradural cavernous segment 3. Has vessel characteristics, tortuosity or morphology or unfavorable aneurysm morphology (e.g., determined from baseline or preprocedure imaging, or which may be evidenced by excessive resistance felt during the procedure) that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device 4. Has significant intracranial atherosclerotic disease or stenosis determined from baseline or pre-procedure imaging 5. If the target intracranial aneurysm is classified as ruptured, patient is neurologically unstable or has a Hunt \& Hess Score of ≥ 3 6. Has a history of intracranial vasospasm not responsive to medical therapy 7. Has undergone coiling or stenting of a non-target intracranial aneurysm within 30 days prior to study treatment or has a non-target intracranial aneurysm that is expected to be treated within 12 months following the treatment of the target aneurysm 8. Treatment with flow diverting stent implant is anticipated 9. A planned, staged procedure is anticipated 10. Has Moya-Moya disease, arteriovenous malformation(s), arteriovenous fistula(e), intracranial tumor(s), intracranial hematoma(s), any other intracranial vascular malformation, or any previous major intracranial surgery 11. Has had a recent (within 90 days) ischemic stroke, TIA, or intracranial hemorrhage 12. Has a baseline mRS score ≥2 13. Has a known coagulopathy or is on chronic anticoagulant therapy 14. Is pregnant or intends to become pregnant during the study or is breastfeeding 15. Is concurrently involved in another study that could affect outcomes of IA treatment 16. Has evidence of active cancer, terminal illness, high risk of embolic stroke, unstable atrial fibrillation, significant co-morbidities, major surgery ≤ 30 days pre-procedure, psychiatric disorders, substance abuse, or a life expectancy of less than 5 years 17. Has a contraindication to angiography, radiographic contrast agents, or any medications that are typically used during the procedure, and any other contraindications listed in the Investigational DFU 18. Has a confirmed allergy to platinum, tungsten, nickel (e.g. nitinol), or other elements used in the manufacturing of the investigational device

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)

FacilityCityRegionStatus
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
Official registry record

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