Citadel Embolization Device Study
Primary Purpose
Unruptured Wide-neck Aneurysms
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Citadel Embolization Device
Sponsored by
About this trial
This is an interventional device feasibility trial for Unruptured Wide-neck Aneurysms
Eligibility Criteria
Inclusion Criteria:
1. Has a single, unruptured or ruptured target intracranial aneurysm that is suitable for endovascular treatment.
Exclusion Criteria:
1.Target aneurysm has been previously treated
Sites / Locations
- Carondelet St. Joseph HospitalRecruiting
- California Pacific Medical CenterRecruiting
- UCSF Medical CenterRecruiting
- RIA NeurovascularRecruiting
- Baptist HealthRecruiting
- University of Miami/Jackson MemorialRecruiting
- Northwestern UniversityRecruiting
- Indiana MethodistRecruiting
- Kansas University Medical CenterRecruiting
- Baptist HealthRecruiting
- University of KentuckyRecruiting
- UMass Memorial HealthRecruiting
- McLaren Health CenterRecruiting
- Spectrum HealthRecruiting
- Washington UniversityRecruiting
- Montefiore Medical CenterRecruiting
- Cleveland ClinicRecruiting
- Oregon Health & Sciences University (OHSU)Recruiting
- Thomas Jefferson UniversityRecruiting
- Medical University of South Carolina
- West Virginia University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Citadel Embolization Device
Arm Description
The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04057352
First Posted
August 1, 2019
Last Updated
September 29, 2023
Sponsor
Stryker Neurovascular
1. Study Identification
Unique Protocol Identification Number
NCT04057352
Brief Title
Citadel Embolization Device Study
Official Title
The Citadel Embolization Device Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2019 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
March 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stryker Neurovascular
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unruptured Wide-neck Aneurysms
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Citadel Embolization Device
Arm Type
Other
Arm Description
The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.
Intervention Type
Device
Intervention Name(s)
Citadel Embolization Device
Intervention Description
The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.
Primary Outcome Measure Information:
Title
Primary Safety Endpoint is stroke-related neurologic death, or major ipsilateral or disabling stroke in the territory supplied by the treated artery
Description
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.
Time Frame
12 months post-procedure
Title
Primary Effectiveness Endpoint of this study is adequate aneurysm occlusion without retreatment or significant parent artery stenosis (>50% stenosis).
Description
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.
Time Frame
12 months post-procedure
Secondary Outcome Measure Information:
Title
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.
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.
Time Frame
12 months post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Has evidence of active cancer, terminal illness, high risk of embolic stroke, atrial fibrillation, significant co-morbidities, major surgery ≤ 30 days pre-procedure, psychiatric disorders, substance abuse, or a life expectancy of less than 5 years
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Strohmeyer
Phone
267-337-5012
Email
john.strohmeyer@stryker.com
First Name & Middle Initial & Last Name or Official Title & Degree
Stacy Phung
Phone
(678) 469-2428
Email
stacy.phung@stryker.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ansaar Rai, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carondelet St. Joseph Hospital
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachael Taoka
Phone
520-872-1938
Email
rachael2.taoka@tenethealth.com
First Name & Middle Initial & Last Name & Degree
Alexander Coon, MD
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teji Dulai
Phone
415-600-1078
Email
teji.dulai@sutterhealth.org
First Name & Middle Initial & Last Name & Degree
Joey English, MD
Facility Name
UCSF Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AJ Tongson
Email
a.j.tongson@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Daniel Cooke, MD
Facility Name
RIA Neurovascular
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Thompson
Phone
720-579-0965
Email
ashley.thompson3@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Emily Malecha
Phone
303-357-5443
Email
emily.malecha@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Don Frei, MD
Facility Name
Baptist Health
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Oberhaus
Phone
904-202-7089
Email
Jordan.Oberhaus@bmcjax.com
First Name & Middle Initial & Last Name & Degree
Ricardo Hanel, MD
Facility Name
University of Miami/Jackson Memorial
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelsalem
Email
aaa824@miami.edu
First Name & Middle Initial & Last Name & Degree
Miguel Bandes
Email
mab816@miami.edu
First Name & Middle Initial & Last Name & Degree
Robert Starke, MD
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brett Rydzon
Email
brett.rydzon@nm.org
First Name & Middle Initial & Last Name & Degree
Babak Jahromi, MD
Facility Name
Indiana Methodist
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Snyder
Email
lmillar@iu.edu
First Name & Middle Initial & Last Name & Degree
Bradley Bohnstedt, MD
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Max Hardenbrook
Phone
913-588-6191
Email
mhardenbrook@kumc.edu
First Name & Middle Initial & Last Name & Degree
Koji Ebersole, MD
Facility Name
Baptist Health
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Calhoun
Email
sara.calhoun@bhsi.com
First Name & Middle Initial & Last Name & Degree
Curtis Given, MD
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Norris
Email
rachel.norris@uky.edu
First Name & Middle Initial & Last Name & Degree
Justin Fraser, MD
Facility Name
UMass Memorial Health
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noelle Bodkin
Email
noelle.bodkin@umassmed.edu
First Name & Middle Initial & Last Name & Degree
Jasmeet Singh, MD
Facility Name
McLaren Health Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marci Roberts
Phone
810-342-4071
Email
marci.roberts@mclaren.org
First Name & Middle Initial & Last Name & Degree
Valentyna Onishcuk
Email
Valentyna.Onishchuk@mclaren.org
First Name & Middle Initial & Last Name & Degree
Mahmound Rayes, MD
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leo Gallagher
Email
leo.gallagher@spectrumhealth.org
First Name & Middle Initial & Last Name & Degree
Justin Singer, MD
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brigette Vaughn
Phone
314-273-0368
Email
b.vaughn@wustl.edu
First Name & Middle Initial & Last Name & Degree
Joshua Osbun, MD
Facility Name
Montefiore Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lavinia Williams
Email
lavwilliam@montefiore.org
First Name & Middle Initial & Last Name & Degree
Genesis Liriano
Phone
718-920-2469
Email
gliriano@montefiore.org
First Name & Middle Initial & Last Name & Degree
David Altschul, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Sweeney, RN, BSN
Phone
216-445-4488
Email
SWEENEL2@ccf.org
First Name & Middle Initial & Last Name & Degree
Mark Bain, MD
Facility Name
Oregon Health & Sciences University (OHSU)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie Bode
Email
bode@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Ryan Priest, MD
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadirah Jones
Phone
215-955-7962
Email
Nadirah.Jones2@Jefferson.edu
First Name & Middle Initial & Last Name & Degree
Michael Gooch, MD
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Withdrawn
Facility Name
West Virginia University Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Domico
Phone
304-293-7012
Email
Jennifer.Domico@wvumedicine.org
First Name & Middle Initial & Last Name & Degree
Ansaar Rai, MD
12. IPD Sharing Statement
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Citadel Embolization Device Study
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