What side effects are associated with this type of intervention?

Common treatments for intracranial aneurysms, such as surgical clipping and endovascular coiling, have side effects including infection, bleeding, and stroke. Endovascular coiling can also lead to coil migration, aneurysm recurrence, and thromboembolic events. Surgical clipping carries risks of cranial nerve damage and longer recovery times. Newer interventions like the Kaneka iED Coil System may share these risks and could have additional device-specific complications that are still under investigation.

What prior FDA approvals exist?

The FDA has approved several endovascular treatments for intracranial aneurysms, including various coil systems and stents. These devices are designed to promote blood clotting within the aneurysm, thereby preventing rupture. Notable examples include the Guglielmi Detachable Coil (GDC) and the Pipeline Embolization Device (PED). These treatments are minimally invasive and involve threading a catheter through the blood vessels to the site of the aneurysm, where coils or stents are deployed to stabilize the aneurysm and reduce the risk of bleeding.

What other types of research exist?

Promising novel alternatives for the treatment of intracranial aneurysms in 2024 include the Kaneka iED Coil System, which is designed for wide-necked ruptured and unruptured aneurysms. This system has been evaluated for its safety, efficacy, and cost-effectiveness. Other emerging treatments may include advanced endovascular techniques, flow diverters, and novel stent-assisted coiling methods, which are continually being refined and tested in clinical trials.

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Coil System

Kaneka i-ED Coil for Brain Aneurysm (CLASS Trial)

N/A

Recruiting

Led By Reade De Leacy

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aneurysm 6-14 mm in diameter

The aneurysm has not been previously treated by coiling or clipping

Must not have

Target aneurysm has had previous coil treatment or has been surgically clipped

Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new type of coil called the Kaneka iED to treat brain aneurysms. It aims to help patients, especially those with wide-necked aneurysms, by using fewer coils to seal the aneurysm, which could lower costs and improve safety.

Who is the study for?

This trial is for adults aged 18-80 with wide neck brain aneurysms that haven't been treated before. Candidates must be able to consent, or have a guardian who can, and agree to follow-up evaluations. They should be in relatively good health (Hunt and Hess grade 0-3) without conditions limiting life expectancy under two years.

What is being tested?

The Kaneka i-ED coil system is being tested on patients with certain brain aneurysms to see if it's safe, effective, and cost-efficient. This study involves two groups of patients matched based on similar characteristics, with one group receiving the new treatment.

What are the potential side effects?

While specific side effects are not listed here, endovascular treatments like coiling can generally include risks such as reaction to contrast dye, bleeding at the catheter site, or more rarely stroke-like symptoms due to vessel injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My aneurysm is between 6 and 14 mm wide.

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My aneurysm has not been treated before.

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I am between 18 and 80 years old.

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My brain hemorrhage severity is mild to moderate.

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I have a brain aneurysm with a wide neck or it's at a branching point.

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My doctor says I need a special procedure for my brain aneurysm.

Exclusion Criteria

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

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My aneurysm was previously treated with coils or surgery.

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My condition is severe after a brain hemorrhage.

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My life expectancy is less than 2 years due to other health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 18 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of coils used

Number of device related serious adverse events

Number of patients with Modified Raymond Roy 1-2 Occlusion classification without retreatment

+1 more

Secondary study objectives

Aneurysm recurrence/coil compaction

Change in Occlusion outcome status

Changes in Modified Rankin Scale (mRS) score

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Kaneka i-ED coilExperimental Treatment1 Intervention

Patients in the experimental arm will be treated according to the standard of care for endovascular aneurysm coiling, with no procedural modifications related to the use of the experimental device.

Group II: Matched patients who underwent intracranial aneurysm embolizationActive Control1 Intervention

The comparator arm will be comprised of propensity matched patients who underwent intracranial aneurysm embolization as part of the FEAT Trial (NCT01655784).

0 / 9Eligibility 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 intracranial aneurysms include microsurgical clipping and endovascular coiling. Microsurgical clipping involves placing a clip at the base of the aneurysm to block blood flow and prevent rupture. Endovascular coiling uses a catheter to insert coils into the aneurysm, promoting blood clotting and reducing the risk of rupture. These treatments are vital for patients as they significantly lower the risk of aneurysm rupture, which can lead to severe neurological damage or death.

Microsurgical treatment of internal carotid artery aneurysms.The development and understanding of intracranial aneurysm based on rabbit model.