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Embolization Device
Citadel Embolization Device for Aneurysm
N/A
Recruiting
Led By Ansaar Rai, MD
Research Sponsored by Stryker Neurovascular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aneurysm size is between 6-12 mm
Has a single, unruptured or ruptured target intracranial aneurysm that is suitable for endovascular treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-procedure
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of a new device to treat aneurysms.
Who is the study for?
This trial is for adults aged 18-80 with a specific type of brain aneurysm that's wide-necked and saccular, measuring 6-12 mm. Participants must be stable if the aneurysm has ruptured (with a low Hunt & Hess Score) and agree to follow study procedures. Exclusions include pregnancy, other ongoing studies affecting outcomes, previous treatment of the target aneurysm, planned future treatments within a year, certain health conditions like coagulopathy or significant vessel disease.Check my eligibility
What is being tested?
The Citadel Embolization Device Study tests Stryker Neurovascular's new device designed for treating wide-neck intracranial aneurysms when used alongside Target Detachable Coils. The goal is to evaluate its safety and effectiveness in managing these complex cases.See study design
What are the potential side effects?
While not explicitly listed in the provided information, typical side effects from embolization devices may include reactions to contrast agents used during the procedure such as nausea or rash; bruising or bleeding at the catheter insertion site; clotting issues; and potential risks associated with endovascular treatments like stroke.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My aneurysm is between 6-12 mm in size.
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I have one brain aneurysm that can be treated without open surgery.
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My brain aneurysm ruptured but I am neurologically stable.
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I am between 18 and 80 years old.
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My aneurysm is wide-necked and either at a branching point or on the side of a vessel.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Effectiveness Endpoint of this study is adequate aneurysm occlusion without retreatment or significant parent artery stenosis (>50% stenosis).
Primary Safety Endpoint is stroke-related neurologic death, or major ipsilateral or disabling stroke in the territory supplied by the treated artery
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.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Citadel Embolization DeviceExperimental Treatment1 Intervention
The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.
Find a Location
Who is running the clinical trial?
Stryker NeurovascularLead Sponsor
35 Previous Clinical Trials
12,589 Total Patients Enrolled
Ansaar Rai, MDPrincipal InvestigatorWest Virginia University
2 Previous Clinical Trials
548 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My aneurysm is located outside the brain covering.My aneurysm is between 6-12 mm in size.The aneurysm has a specific shape called "saccular."I am scheduled for a planned, step-by-step surgery.Your baseline mRS score is 2 or higher.I am allergic or cannot have certain medical imaging dyes or medications used in procedures.I have severe narrowing of the arteries in my brain.I have a serious health condition besides cancer that affects my life expectancy or ability to undergo treatment.I am expected to receive a flow diverting stent implant.I have a blood clotting disorder or am on long-term blood thinners.I have one brain aneurysm that can be treated without open surgery.I have had a stroke or brain bleed in the last 3 months.My brain aneurysm ruptured but I am neurologically stable.My brain aneurysm has burst and my neurological condition is unstable.I have had or will have treatment for a brain aneurysm unrelated to my main condition within a year.My blood vessels' shape or condition makes it unsafe to use certain devices for my aneurysm.My aneurysm has been treated before.I have a specific brain condition or have had major brain surgery.I am between 18 and 80 years old.I have had brain blood vessel spasms that did not improve with medication.My aneurysm is wide-necked and either at a branching point or on the side of a vessel.
Research Study Groups:
This trial has the following groups:- Group 1: Citadel Embolization Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is my profile suitable to join this clinical investigation?
"In order to join the trial, candidates must suffer from aneurysm and be within a certain age range (18-80). A total of 150 individuals will eventually participate in this study."
Answered by AI
Does this research endeavor include elderly participants?
"Eligible participants in this trial are required to be 18 years of age or older, with a maximum acceptable age of 80."
Answered by AI
How many venues are engaging in this trial?
"At the moment, 13 distinct medical facilities are running this trial. These sites are located in Chicago, Charleston and San Francisco as well as 10 other cities; it is strongly recommended that you select a clinic near your current location to reduce any transportation needs if accepted into the study."
Answered by AI
Is it still possible for participants to enter this experiment?
"Per the clinicaltrials.gov database, this trial is not presently looking for participants. It was initially posted on July 17th 2019 and most recently edited on September 14th 2022. However, 152 other studies are currently recruiting patients across the US right now."
Answered by AI
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