Citadel Embolization Device Study

Running, not enrolling · Not applicable

Conditions studied: Unruptured Wide-neck Aneurysms

In brief

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.

Key facts

Study ID

NCT04057352

Run by

Stryker Neurovascular

People needed

150

Starts

2019-07-18

Expected to finish

2026-11-15

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age is ≥18 and ≤80 years
• 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.
• Aneurysm morphology is saccular
• Aneurysm size is between 6-12 mm
• Has a wide-neck, saccular aneurysm, either bifurcation or sidewall, with a dome to neck ratio <2 or neck ≥4 mm
• If the target intracranial aneurysm is classified as ruptured, patient must be neurologically stable with a Hunt \& Hess Score of 1 or 2.
• Must be willing to comply with protocol required procedures and follow up
• 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 may not qualify if…

• Target aneurysm has been previously treated
• Target aneurysm is in any extradural location, including the extradural cavernous segment
• 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
• Has significant intracranial atherosclerotic disease or stenosis determined from baseline or pre-procedure imaging
• If the target intracranial aneurysm is classified as ruptured, patient is neurologically unstable or has a Hunt \& Hess Score of ≥ 3
• Has a history of intracranial vasospasm not responsive to medical therapy
• 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
• Treatment with flow diverting stent implant is anticipated
• A planned, staged procedure is anticipated
• 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
• Has had a recent (within 90 days) ischemic stroke, TIA, or intracranial hemorrhage
• Has a baseline mRS score ≥2
• Has a known coagulopathy or is on chronic anticoagulant therapy
• Is pregnant or intends to become pregnant during the study or is breastfeeding
• Is concurrently involved in another study that could affect outcomes of IA treatment
• 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
• 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
• Has a confirmed allergy to platinum, tungsten, nickel (e.g. nitinol), or other elements used in the manufacturing of the investigational device

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• UCSF Medical Center — San Francisco, California, United States
• John Muir Health — Walnut Creek, California, United States
• RIA Neurovascular — Englewood, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Baptist Health — Jacksonville, Florida, United States
• University of Miami/Jackson Memorial — Miami, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Indiana Methodist — Indianapolis, Indiana, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Baptist Health — Lexington, Kentucky, United States
• University of Kentucky — Lexington, Kentucky, United States
• UMass Memorial Health — Worcester, Massachusetts, United States
• McLaren Health Center — Flint, Michigan, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Weill Cornell — New York, New York, United States
• Montefiore Medical Center — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• University of Washington — Seattle, Washington, United States
• West Virginia University Hospital — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.