← Back to Search

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 below
Select...
My aneurysm is between 6-12 mm in size.
Select...
I have one brain aneurysm that can be treated without open surgery.
Select...
My brain aneurysm ruptured but I am neurologically stable.
Select...
I am between 18 and 80 years old.
Select...
My aneurysm is wide-necked and either at a branching point or on the side of a vessel.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-procedure for reporting.

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
34 Previous Clinical Trials
12,089 Total Patients Enrolled
Ansaar Rai, MDPrincipal InvestigatorWest Virginia University
1 Previous Clinical Trials
376 Total Patients Enrolled

Media Library

Citadel Embolization Device (Embolization Device) Clinical Trial Eligibility Overview. Trial Name: NCT04057352 — N/A
Wide-neck Aneurysms Research Study Groups: Citadel Embolization Device
Wide-neck Aneurysms Clinical Trial 2023: Citadel Embolization Device Highlights & Side Effects. Trial Name: NCT04057352 — N/A
Citadel Embolization Device (Embolization Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04057352 — N/A

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
~47 spots leftby Jun 2026