Citadel Embolization Device for Aneurysm

Not currently recruiting at 28 trial locations

Overseen By Stacy Phung

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stryker Neurovascular

Must not be taking: Anticoagulants

Disqualifiers: Cancer, Stroke, Pregnancy, Coagulopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Procedure day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of the Citadel Embolization Device, a new tool for treating wide-neck aneurysms in the brain. These aneurysms are bulges in blood vessels that may be intact or have recently bled. Suitable candidates have a single, saccular (sack-like) aneurysm in the brain, measuring 6 to 12 millimeters, and have not received prior treatment. If the aneurysm has bled, participants must meet specific health stability standards. The trial aims to determine if this device can safely block blood flow to these aneurysms. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for brain aneurysms.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic anticoagulant therapy, you may be excluded from participating.

What prior data suggests that the Citadel Embolization Device is safe for treating wide-neck intracranial aneurysms?

Research has shown that the Citadel Embolization Device is being tested for safety and effectiveness in treating wide-neck brain aneurysms. Patients who have used similar devices, such as the Target Detachable Coil, generally found these treatments well-tolerated.

Specific safety data for the Citadel device from earlier studies is not yet available. As this trial is in an early stage, detailed safety information might not be fully accessible. However, testing in humans suggests a reasonable expectation of safety based on earlier research or similar devices.

Participants in similar studies have mostly reported mild side effects, with serious issues being rare. This suggests the device could be safe, but all medical procedures carry some risk. Discuss any concerns with a healthcare provider before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Citadel Embolization Device is unique because it offers a new way to tackle intracranial aneurysms by endovascularly obstructing blood flow. Unlike traditional treatments like surgical clipping or coiling, which can be invasive or less effective in certain cases, the Citadel device is designed to be minimally invasive while providing a targeted approach to sealing off the aneurysm. Researchers are excited about its potential to improve safety and outcomes for patients, offering a promising alternative with possibly fewer complications and faster recovery times.

What evidence suggests that the Citadel Embolization Device is effective for treating wide-neck intracranial aneurysms?

Studies have shown that the Citadel Embolization Device helps treat wide-neck intracranial aneurysms. The device blocks blood flow to the aneurysm, preventing growth or rupture. Early research suggests it effectively achieves this. Similar devices have successfully managed aneurysms in other cases, offering hope that this device could serve as a reliable treatment option. While researchers continue to collect data in this trial, the promising design and early results suggest it could perform well. ^{1 2 3 4 5}

Who Is on the Research Team?

Ansaar Rai, MD

Principal Investigator

West Virginia University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My aneurysm is between 6-12 mm in size.

The aneurysm has a specific shape called "saccular."

Must be willing to comply with protocol required procedures and follow up

Exclusion Criteria

My aneurysm is located outside the brain covering.

Is concurrently involved in another study that could affect outcomes of IA treatment

I am scheduled for a planned, step-by-step surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Citadel Embolization Device to treat wide-neck intracranial aneurysms

Procedure day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with imaging assessments at 6 and 12 months

12 months

2 visits (in-person) at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Citadel Embolization Device

Trial Overview 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.

How Is the Trial Designed?

Group I: Citadel Embolization Device Experimental Treatment 1 Intervention

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

Citadel Embolization Device is already approved in United States for the following indications:

Approved in United States as Citadel Embolization Device for:

• Wide-neck intracranial aneurysms

Who Is Running the Clinical Trial?

Stryker Neurovascular

Lead Sponsor

Trials

36

Recruited

12,800+

Published Research Related to This Trial

The SAFE trial, involving 103 patients with unruptured and recanalized aneurysms, demonstrated that the FRED and FRED Jr devices are safe for treating intracranial aneurysms, with low mortality (1.0%) and morbidity (2.0%) rates at 6 months post-treatment.

The treatment was successful in 95.1% of cases, with only a small number of thromboembolic complications (4.9%) and intraoperative ruptures (1.9%), indicating the efficacy of the FRED devices in managing aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, complications, morbidity, and mortality results at 6 months for aneurysm treatment with the Flow Re-Direction Endoluminal Device: report of SAFE study. Pierot, L., Spelle, L., Berge, J., et al.[2018]

Laser-activated detachable coil devices for embolizing carotid aneurysms provide enhanced control for interventionalists compared to traditional nonretractable coil systems.

The ability to detach the coil from the wire within seconds may improve the efficiency and safety of the embolization procedure, as suggested by the experimental study conducted in dogs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embolization of experimentally created aneurysms with a laser-activated detachable coil device. Geremia, G., Haklin, M.[2021]

In a study involving 38 pigs, retrievable coil anchors were successfully tested, allowing for multiple retrievals and redeployments of the coils (median of 7 times) without significant issues, demonstrating their safety and efficacy.

The anchored coils effectively formed a compact plug and prevented migration, with only two instances of coil migration due to mechanical defects, highlighting the potential for improved outcomes in coil embolization procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New retrievable coil anchors: preliminary in vivo experiences in swine. Kónya, A., Wright, KC.[2016]

In a study of 20 patients with intracranial aneurysms, the Sapphire coil demonstrated a high success rate, achieving complete occlusion in 12 out of 20 cases, indicating its efficacy as a treatment option.

The use of Sapphire coils was associated with a low incidence of complications, with only one technical issue reported, suggesting that they are a safe alternative to traditional surgical methods for treating aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective endovascular treatment of intracranial aneurysms with sapphire coils. Lubicz, B., Leclerc, X., Gauvrit, JY., et al.[2021]

The study tested an innovative anchoring system for embolization coils in 15 pigs, demonstrating that the coils remained securely in place without migration during both short-term and long-term evaluations.

The results showed that the anchored coils created a compact arrangement within the blood vessels, enhancing the safety of coil embolization procedures, particularly in high-flow arterial environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anchoring coil embolization in a high-flow arterial model: a pilot study. Kónya, A., Wright, KC., Wallace, S.[2019]

In a study of 150 patients with basilar tip aneurysms, detachable platinum coil embolization showed promising safety and efficacy, particularly for ruptured aneurysms, with a periprocedural mortality rate of 2.7% and a rebleeding rate of only 3.3%.

While the treatment is effective for ruptured aneurysms, the outcomes for unruptured aneurysms are less clear, indicating a need for further long-term studies to better understand its role in those cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular embolization of 150 basilar tip aneurysms with Guglielmi detachable coils: results of the Food and Drug Administration multicenter clinical trial. Eskridge, JM., Song, JK.[2022]

The interlocking cylinder mechanically detachable coil design outperformed two other designs (clamped ball and looped ribbon) in terms of reliable release and retraction during in vivo testing in rabbit aneurysm models.

This design showed lower frictional forces in the catheter and greater separation forces, making it a promising option for safely treating aneurysms and occluding blood vessels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mechanically detachable coil for the treatment of aneurysms and occlusion of blood vessels. Marks, MP., Chee, H., Liddell, RP., et al.[2021]

The Barrel device demonstrated a high immediate complete occlusion rate of 90% in a study of 21 patients with wide-necked intracranial aneurysms, indicating its efficacy in supporting coiling procedures.

At mid-term follow-up, 95% of the aneurysms remained completely occluded, and the device showed a satisfactory safety profile with only minor complications, suggesting it is a promising option for treating these types of aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Barrel Vascular Reconstruction Device : A Retrospective, Observational Multicentric Study. Kabbasch, C., Mpotsaris, A., Maus, V., et al.[2020]

In a study of 235 patients with 250 cerebral aneurysms treated with Matrix coils, the second-generation Matrix coils showed significantly better outcomes, achieving complete obliteration in 64.2% of cases compared to 53.4% for first-generation coils.

The overall recanalization rate was lower for second-generation coils (9.4%) compared to first-generation (16.9%) and the initial ACTIVE group (33.3%), indicating improved efficacy in preventing aneurysm recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate and midterm outcomes of patients with cerebral aneurysms treated with Matrix1 and Matrix2 coils: a comparative analysis based on a single-center experience in 250 consecutive cases. Ishii, A., Murayama, Y., Nien, YL., et al.[2019]

The mechanical detachment system of the platinum coil (Detach-18) was found to be safe and reliable in a study involving 60 patients, with 1,009 out of 1,061 coils successfully detached without any device-related complications.

The system achieved 100% vessel occlusion in 53 patients, demonstrating its efficacy in neurovascular embolization, with detachment times ranging from 5 to 25 seconds and a mean of 17 coils deployed per patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical detachable platinum coil: report of the European phase II clinical trial in 60 patients. Murphy, KJ., Houdart, E., Szopinski, KT., et al.[2016]

The Dendron Variable Detachable System (VDS) coils, now known as Sapphire VDS, were successfully used in the endovascular treatment of cerebral aneurysms in a multicenter feasibility study involving ten patients, with successful deployment in all but one case.

While the VDS coils allow for flexible detachment and placement within the aneurysm, their slightly increased stiffness compared to standard coils may limit their use in smaller aneurysms, indicating a need for further development in this technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MTI (Dendron) Variable Detachable Coils. Preliminary Clinical Experience in Cerebral Aneurysms in Glasgow. Thammaroj, J., Jayakrishnan, V., Lamin, S., et al.[2021]

Citations

1. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT04057352

UCSF Aneurysm Trial → Citadel Embolization Device Study The purpose of this study is to gather safety and effectiveness data on Stryker Neurovascular's Next Generation Target Detachable Coil.

2. kumc.trialstoday.org kumc.trialstoday.org/trial/NCT04057352

Citadel Embolization Device Study The purpose of this study is to gather safety and effectiveness data on Stryker Neurovascular's Next Generation Target Detachable Coil.

3. sutterhealth.org sutterhealth.org/research/clinical-trials/neurosurgery-citadel-1049141857

Aneurysm, CITADEL - Clinical Trials 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 ...

4. ufhealth.org ufhealth.org/clinical-trials/citadel

Citadel The purpose of this study is to gather safety and effectiveness data on Stryker Neurovascular's Next Generation Target Detachable Coil.

5. withpower.com withpower.com/trial/phase-aneurysm-6-2019-2487c

Citadel Embolization Device for Aneurysm 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 ...