Citadel Embolization Device Study

Last updated: March 19, 2025
Sponsor: Stryker Neurovascular
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

Citadel Embolization Device

Clinical Study ID

NCT04057352
CDM10001448
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age is ≥18 and ≤80 years

  2. 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.

  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 toneck ratio <2 or neck ≥4 mm

  6. If the target intracranial aneurysm is classified as ruptured, patient must beneurologically 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 informedconsent prior to initiation of any screening or study procedures

Exclusion

Exclusion Criteria:

  1. Target aneurysm has been previously treated

  2. Target aneurysm is in any extradural location, including the extradural cavernoussegment

  3. 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

  4. Has significant intracranial atherosclerotic disease or stenosis determined frombaseline or pre-procedure imaging

  5. If the target intracranial aneurysm is classified as ruptured, patient isneurologically 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 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

  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 vascularmalformation, 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 dayspre-procedure, psychiatric disorders, substance abuse, or a life expectancy of lessthan 5 years

  17. 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

  18. Has a confirmed allergy to platinum, tungsten, nickel (e.g. nitinol), or otherelements used in the manufacturing of the investigational device

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Citadel Embolization Device
Phase:
Study Start date:
July 18, 2019
Estimated Completion Date:
June 30, 2026

Study Description

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.

Connect with a study center

  • Carondelet St. Joseph Hospital

    Tucson, Arizona 85710
    United States

    Active - Recruiting

  • California Pacific Medical Center

    San Francisco, California 94114
    United States

    Active - Recruiting

  • UCSF Medical Center

    San Francisco, California 94143
    United States

    Active - Recruiting

  • University of California- San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • John Muir Health

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • RIA Neurovascular

    Englewood, Colorado 80113
    United States

    Active - Recruiting

  • Baptist Health

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • University of Miami/Jackson Memorial

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Indiana Methodist

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Kansas University Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Baptist Health

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

  • University of Kentucky

    Lexington, Kentucky 40506
    United States

    Active - Recruiting

  • UMass Memorial Health

    Worcester, Massachusetts 01605
    United States

    Active - Recruiting

  • McLaren Health Center

    Flint, Michigan 48532
    United States

    Active - Recruiting

  • Spectrum Health

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Montefiore Medical Center

    New York, New York 10467
    United States

    Active - Recruiting

  • Weill Cornell

    New York, New York 10021
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Oregon Health & Sciences University (OHSU)

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • West Virginia University Hospital

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

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