Citadel Embolization Device Study

The Citadel Embolization Device Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Unruptured Wide-neck Aneurysms
• Intervention / Treatment: Device: Citadel Embolization Device

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • San Francisco, California, United States, 94143
      • UCSF Medical Center
    • San Francisco, California, United States, 94114
      • California Pacific Medical Center
    • Walnut Creek, California, United States, 94598
      • John Muir Health
  • Colorado
    • Englewood, Colorado, United States, 80113
      • RIA Neurovascular
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Health
    • Miami, Florida, United States, 33136
      • University of Miami/Jackson Memorial
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana Methodist
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Health
  • Michigan
    • Flint, Michigan, United States, 48532
      • McLaren Health Center
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • New York, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10021
      • Weill Cornell
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Hospital
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Citadel Embolization Device; The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.	Device: Citadel Embolization Device; The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint is stroke-related neurologic death, or major ipsilateral or disabling stroke in the territory supplied by the treated artery	Occurring within 12 months post-procedure as adjudicated by an independent Clinical Events Committee (CEC); With major ipsilateral stroke defined as a stroke associated with an increase in NIHSS score ≥ 4 points persisting ≥ 24 hours, and;; With disabling stroke defined as a stroke that results in a modified Rankin Scale (mRS) score ≥ 3 assessed at a minimum of 90 days post-stroke event.	12 months post-procedure
Primary Effectiveness Endpoint of this study is adequate aneurysm occlusion without retreatment or significant parent artery stenosis (>50% stenosis).	The determination of adequate aneurysm occlusion using Raymond-Roy classification will be made if either of the following criteria in the description are met: -100% occlusion (Raymond Class I) demonstrated by Digital Subtraction Angiography (DSA) measurement at 12 months (± 3 months) post-procedure, or -Stable Raymond class II demonstrated on 2 serial imaging measurements using Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) and/or DSA obtained a minimum of 6 months (± 1 month) apart. Post-procedure and 12-month imaging must be completed with DSA.	12 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Safety Endpoint of this study is any stroke event occurring through 12 months post-procedure, where a stroke event is defined as per what is noted in the description.	-Rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours with no apparent cause other than of vascular origin, including ischemic stroke and/or hemorrhagic stroke (i.e., intraparenchymal hemorrhage [IPH], subarachnoid hemorrhage [SAH], subdural hemorrhage [SDH], epidural hemorrhage [EDH]) accompanied with radiological evidence.	12 months post-procedure

Collaborators and Investigators

• Sponsor: Stryker Neurovascular
• Investigators: Principal Investigator: Ansaar Rai, MD, West Virginia University

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2019
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aneurysm
• Other Study ID Numbers: CDM10001448

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No