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Using a new device to treat wide-neck brain aneurysms

The Citadel Embolization Device Study

NA · Stryker Neurovascular · NCT04057352

This study is testing a new device to see if it can safely treat wide-neck brain aneurysms in adults without causing any problems.

Quick facts

PhaseNA
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorStryker Neurovascular (industry)
Locations27 sites (Tucson, Arizona and 26 other locations)
Trial IDNCT04057352 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Citadel Embolization Device, developed by Stryker Neurovascular, for treating unruptured wide-neck intracranial aneurysms. Participants will include adults aged 18 to 80 with specific aneurysm characteristics, and the device aims to occlude blood flow in these aneurysms through an endovascular approach. The study will gather data on the device's performance in a controlled setting to assess its potential benefits and risks.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a single, unruptured or recently ruptured wide-neck saccular aneurysm suitable for endovascular treatment.

Not a fit: Patients with previously treated aneurysms or those with aneurysms outside the specified size and morphology criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could provide a safer and more effective treatment option for patients with wide-neck intracranial aneurysms.

How similar studies have performed: Other studies have shown promise with similar endovascular approaches for treating aneurysms, but the Citadel Embolization Device represents a novel intervention.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Tucson, Arizona and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Unruptured Wide-neck Aneurysms

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.