for people ages 18-80 (full criteria)
at San Francisco, California and other locations
study started
completion around
Principal Investigator
by Daniel Cooke
Headshot of Daniel Cooke
Daniel Cooke



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.

Official Title

The Citadel Embolization Device Study


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.


Unruptured Wide-neck Aneurysms, Aneurysm, Citadel Embolization Device


You can join if…

Open to people ages 18-80

  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

You CAN'T join if...

  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, 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


  • UCSF Medical Center accepting new patients
    San Francisco California 94143 United States
  • California Pacific Medical Center accepting new patients
    San Francisco California 94114 United States

Lead Scientist at UCSF

  • Daniel Cooke
    Daniel Cooke, MD, is an Associate Professor in Residence of Neuro Interventional Radiology in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco. His expertise is in ischemic and hemorrhagic stroke, vascular malignancies of the central nervous system, arteriovenous malformations (AVM), arteriovenous fistula (AVF), and aneurysms of the brain and spine.


accepting new patients
Start Date
Completion Date
Stryker Neurovascular
Study Type
Expecting 150 study participants
Last Updated