Citadel Embolization Device Study

NCT04057352 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CDM10001448
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 25

Brief 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.

Conditions

Unruptured Wide-neck Aneurysms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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.

  12 months post-procedure

Study Arms (1)

Citadel Embolization Device

OTHER

The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.

Device: Citadel Embolization Device

Interventions

Citadel Embolization Device DEVICE

The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.

Citadel Embolization Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Stryker Neurovascular: lead

Study Sites (25)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

California Pacific Medical Center

San Francisco, California, 94114, United States

Location

UCSF Medical Center

San Francisco, California, 94143, United States

Location

John Muir Health

Walnut Creek, California, 94598, United States

Location

RIA Neurovascular

Englewood, Colorado, 80113, United States

Location

University of Florida

Gainesville, Florida, 32608, United States

Location

Baptist Health

Jacksonville, Florida, 32207, United States

Location

University of Miami/Jackson Memorial

Miami, Florida, 33136, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Indiana Methodist

Indianapolis, Indiana, 46202, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Baptist Health

Lexington, Kentucky, 40503, United States

Location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

UMass Memorial Health

Worcester, Massachusetts, 01605, United States

Location

McLaren Health Center

Flint, Michigan, 48532, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Weill Cornell

New York, New York, 10021, United States

Location

Montefiore Medical Center

New York, New York, 10467, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

Study Officials

• Ansaar Rai, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 15, 2019
• Study Start: July 18, 2019
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (25)