Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
150 participants
INTERVENTIONAL
2019-07-18
2026-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Citadel Embolization Device
The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.
Citadel Embolization Device
The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.
Interventions
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Citadel Embolization Device
The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Stryker Neurovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Ansaar Rai, MD
Role: PRINCIPAL_INVESTIGATOR
West Virginia University
Locations
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Carondelet St. Joseph Hospital
Tucson, Arizona, United States
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
Countries
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Other Identifiers
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CDM10001448
Identifier Type: -
Identifier Source: org_study_id
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