Phase
Condition
Aneurysm
Treatment
Citadel Embolization Device
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age is ≥18 and ≤80 years
Has a single, unruptured or ruptured target intracranial aneurysm that is suitablefor endovascular treatment. Definition: For the purposes of this study, a rupturedintracranial aneurysm is defined as one with CT/MRI/LP evidence of subarachnoidhemorrhage 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 toneck ratio <2 or neck ≥4 mm
If the target intracranial aneurysm is classified as ruptured, patient must beneurologically 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 informedconsent prior to initiation of any screening or study procedures
Exclusion
Exclusion Criteria:
Target aneurysm has been previously treated
Target aneurysm is in any extradural location, including the extradural cavernoussegment
Has vessel characteristics, tortuosity or morphology or unfavorable aneurysmmorphology (e.g., determined from baseline or preprocedure imaging, or which may beevidenced by excessive resistance felt during the procedure) that would precludesafe endovascular access to the target aneurysm necessary for treatment with thestudy device
Has significant intracranial atherosclerotic disease or stenosis determined frombaseline or pre-procedure imaging
If the target intracranial aneurysm is classified as ruptured, patient isneurologically 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 30days prior to study treatment or has a non-target intracranial aneurysm that isexpected to be treated within 12 months following the treatment of the targetaneurysm
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 vascularmalformation, 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 dayspre-procedure, psychiatric disorders, substance abuse, or a life expectancy of lessthan 5 years
Has a contraindication to angiography, radiographic contrast agents, or anymedications that are typically used during the procedure, and any othercontraindications listed in the Investigational DFU
Has a confirmed allergy to platinum, tungsten, nickel (e.g. nitinol), or otherelements used in the manufacturing of the investigational device
Study Design
Study Description
Connect with a study center
Carondelet St. Joseph Hospital
Tucson, Arizona 85710
United StatesActive - Recruiting
California Pacific Medical Center
San Francisco, California 94114
United StatesActive - Recruiting
UCSF Medical Center
San Francisco, California 94143
United StatesActive - Recruiting
University of California- San Francisco
San Francisco, California 94143
United StatesSite Not Available
John Muir Health
Walnut Creek, California 94598
United StatesActive - Recruiting
RIA Neurovascular
Englewood, Colorado 80113
United StatesActive - Recruiting
Baptist Health
Jacksonville, Florida 32207
United StatesActive - Recruiting
University of Miami/Jackson Memorial
Miami, Florida 33136
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesActive - Recruiting
Indiana Methodist
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Kansas University Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
Baptist Health
Lexington, Kentucky 40503
United StatesActive - Recruiting
University of Kentucky
Lexington, Kentucky 40506
United StatesActive - Recruiting
UMass Memorial Health
Worcester, Massachusetts 01605
United StatesActive - Recruiting
McLaren Health Center
Flint, Michigan 48532
United StatesActive - Recruiting
Spectrum Health
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
Washington University
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Montefiore Medical Center
New York, New York 10467
United StatesActive - Recruiting
Weill Cornell
New York, New York 10021
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
Oregon Health & Sciences University (OHSU)
Portland, Oregon 97239
United StatesActive - Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
University of Pennsylvania Hospital
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
University of Washington
Seattle, Washington 98104
United StatesActive - Recruiting
West Virginia University Hospital
Morgantown, West Virginia 26506
United StatesActive - Recruiting
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