What side effects are associated with this type of intervention?

Common side effects of embolization treatments for wide-neck aneurysms, such as those using detachable coils, include headache, nausea, and groin pain at the catheter insertion site. Less common but serious complications can include coil migration, aneurysm rupture, ischemic stroke, infection, and allergic reactions to the materials used in the coils or contrast agents.

What prior FDA approvals exist?

The FDA has approved several embolization devices for the treatment of wide-neck intracranial aneurysms. These devices include the Target Detachable Coils, which are used to block blood flow to the aneurysm, promoting clot formation and reducing the risk of rupture. Other similar devices include the Pipeline Embolization Device and the WEB Aneurysm Embolization System, both of which are designed to provide a minimally invasive option for treating complex aneurysms by diverting blood flow away from the aneurysm sac.

What other types of research exist?

Promising alternatives to the Citadel Embolization Device for treating wide-neck aneurysms include the use of flow diverters such as the Pipeline Embolization Device and the Surpass Streamline Flow Diverter. These devices are designed to redirect blood flow away from the aneurysm, promoting thrombosis within the aneurysm sac while maintaining patency of the parent vessel. Additionally, the Woven EndoBridge (WEB) device, which is an intrasaccular flow disruptor, has shown promise in clinical trials for wide-neck aneurysms. These alternatives offer innovative approaches to aneurysm management and are supported by recent clinical data.

← 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

Must not have

Target aneurysm is in any extradural location, including the extradural cavernous segment

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called the Citadel Embolization Device, which is used to block blood flow in brain aneurysms. It targets patients with specific types of aneurysms that are hard to treat otherwise. The device works by being placed inside the aneurysm to stop blood flow and prevent further issues.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My aneurysm is located outside the brain covering.

Select...

I am allergic or cannot have certain medical imaging dyes or medications used in procedures.

Select...

I have severe narrowing of the arteries in my brain.

Select...

I have a serious health condition besides cancer that affects my life expectancy or ability to undergo treatment.

Select...

I am expected to receive a flow diverting stent implant.

Select...

I have a blood clotting disorder or am on long-term blood thinners.

Select...

My brain aneurysm has burst and my neurological condition is unstable.

Select...

My blood vessels' shape or condition makes it unsafe to use certain devices for my aneurysm.

Select...

My aneurysm has been treated before.

Select...

I have a specific brain condition or have had major brain surgery.

Select...

I have had brain blood vessel spasms that did not improve with medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post-procedure

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for wide-neck aneurysms include endovascular techniques such as coil embolization and the use of embolization devices like the Citadel Embolization Device. These treatments work by inserting coils or other embolic materials into the aneurysm sac through a catheter, which induces clot formation and blocks blood flow into the aneurysm. This prevents the aneurysm from growing or rupturing. For wide-neck aneurysms, specialized devices are often used to ensure that the coils remain in place and to provide additional support to the aneurysm walls. This is crucial for patients because wide-neck aneurysms are more challenging to treat due to their shape and size, and these advanced techniques help to reduce the risk of complications and improve outcomes.