Citadel Embolization Device for Aneurysm

Recruiting in Palo Alto (17 mi)

+24 other locations

Overseen by Ansaar Rai, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Stryker Neurovascular

Must not be taking: Anticoagulants

Disqualifiers: Cancer, Stroke, Pregnancy, Coagulopathy, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Citadel Embolization Device for Aneurysm is an effective treatment?

The available research shows that the Citadel Embolization Device, also known as detachable coils, is effective in treating aneurysms. One study on dogs found that these coils allow for better control during the procedure compared to older systems. Another study involving a different type of detachable coil, the Dendron Variable Detachable System, showed successful use in treating cerebral aneurysms in nine out of ten patients. These findings suggest that detachable coils, like the Citadel Embolization Device, are promising for treating aneurysms, offering more control and flexibility during treatment.

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What safety data exists for the Citadel Embolization Device for Aneurysm?

The safety data for the Citadel Embolization Device, also known as the Next Generation Target Detachable Coil or Target Detachable Coils, is not directly mentioned in the provided research. However, similar devices like the Guglielmi Detachable Coils (GDCs) have been evaluated for safety and efficacy in a multicenter clinical trial involving 150 patients with basilar tip aneurysms, leading to FDA approval. Additionally, the safety of coil embolization has been explored in studies involving mechanical detachable platinum coils and retrievable coil anchors, although these are not specifically about the Citadel Embolization Device.

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Is the Citadel Embolization Device a promising treatment for aneurysms?

Yes, the Citadel Embolization Device is a promising treatment for aneurysms. It offers greater control for doctors during the procedure and allows for quick detachment of the coil, which can help in effectively treating aneurysms.

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Eligibility Criteria

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.

Trial Timeline

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

RIA Neurovascular Englewood, CO

University of California- San Francisco San Francisco, CA

Baptist Health Lexington, KY

Oregon Health & Sciences University (OHSU) Portland, OR

More Trial Locations

Who Is Running the Clinical Trial?

Stryker Neurovascular Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Embolization of experimentally created aneurysms with a laser-activated detachable coil device. [2021] Our experimental study in dogs suggests that laser-activated detachable coil devices show promise in the embolization of carotid aneurysms, allowing the interventionalist greater control than possible with nonretractable coil systems and permitting detachment of the coil from the wire in seconds.

2. United States pubmed.ncbi.nlm.nih.gov

MTI (Dendron) Variable Detachable Coils. Preliminary Clinical Experience in Cerebral Aneurysms in Glasgow. [2021] We present our initial clinical experience of Dendron Variable Detachable System (VDS) coils, now Sapphire VDS from MTI, in the endovascular treatment of cerebral aneurysms. VDS coils, uniquely, can be detached at variable points along their length, allowing placement of as much or as little as desired of the coil within the aneurysm. Our ten patients formed part of a multicentre feasibility study. VDS coils were successfully deployed in all but one aneurysm. The electrolytic detachment mechanism with practice is both simple to use and reliable. The coils are however slightly stiffer than standard coils limiting their use in small aneurysms. This remains a technology in evolution.

3. United States pubmed.ncbi.nlm.nih.gov

New retrievable coil anchors: preliminary in vivo experiences in swine. [2016] To design and test retrievable coil anchors to improve the safety and efficacy of coil embolization.

4. United States 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. [2019] Recanalization after coil embolization of cerebral aneurysms remains a limitation of this progressively accepted modality. The Matrix detachable bioabsorbable coil (Boston Scientific Neurovascular, Natick, MA) was developed to overcome this limitation. We report a single-center experience using first- and second-generation Matrix coils.

5. United States pubmed.ncbi.nlm.nih.gov

Selective endovascular treatment of intracranial aneurysms with sapphire coils. [2021] Endovascular treatment with detachable coils is an accepted alternative to surgical clip placement for intracranial aneurysms. The purpose of this study was to evaluate the safety and reliability of the Sapphire coil, a new platinum coil for the treatment of intracranial aneurysms.

6. England 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. [2018] Label="BACKGROUND AND PURPOSE" NlmCategory="OBJECTIVE">Flow diverters are increasingly used for the treatment of intracranial aneurysms. Evaluation of the first devices available for clinical use showed high efficacy of this treatment although safety results were worse compared with coiling or balloon-assisted coiling. The Safety and Efficacy Analysis of FRED Embolic Device in Aneurysm Treatment (SAFE) trial is a single-arm, multicenter, prospective study conducted to precisely analyze the safety and efficacy of the FRED and FRED Jr devices.

7. United States pubmed.ncbi.nlm.nih.gov

Mechanical detachable platinum coil: report of the European phase II clinical trial in 60 patients. [2016] To determine the safety and reliability of the mechanical detachment system of a platinum coil (Detach-18) when used for neurovascular embolization.

8. United States pubmed.ncbi.nlm.nih.gov

Anchoring coil embolization in a high-flow arterial model: a pilot study. [2019] To devise and test an occluding coil anchoring system to improve the safety of coil embolization.

9. United States 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. [2022] To assess the safety and efficacy of aneurysm embolization performed using Guglielmi detachable coils (GDCs), the authors reviewed the results of a cohort of 150 patients with either ruptured (83 patients) or unruptured (67 patients) basilar tip aneurysms treated with these detachable platinum coil devices in the early part of the United States multicenter GDC clinical trial that led to Food and Drug Administration approval for the device.

10. United States pubmed.ncbi.nlm.nih.gov

A mechanically detachable coil for the treatment of aneurysms and occlusion of blood vessels. [2021] To evaluate mechanically detachable coil designs capable of controlled and instantaneous release within an aneurysm or vascular space.

11. Germany pubmed.ncbi.nlm.nih.gov

The Barrel Vascular Reconstruction Device : A Retrospective, Observational Multicentric Study. [2020] The Barrel device is an electrolytically detachable laser cut, closed-cell microstent that is used for neck reconstruction in wide-necked bifurcation and branching aneurysms to support coiling. The key feature is a barrel section that herniates over the aneurysmal ostium. The objective was to evaluate the safety, feasibility and the immediate and mid-term occlusion results of this new device.