Kaneka i-ED Coil for Brain Aneurysm

(CLASS Trial)

Not currently recruiting at 4 trial locations

Overseen By Sydney Edwards

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Multiple aneurysms, Previous coil, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 19

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for brain aneurysms using the Kaneka i-ED Coil System. The researchers aim to determine if this treatment is safe, effective, and cost-efficient compared to traditional methods. Participants will have either a wide-neck or bifurcation intracranial aneurysm (a bulge in a blood vessel in the brain) that can be treated without surgery. Eligible patients are those who have not previously treated their aneurysm and can return for follow-up checks over the next 18 months. As an unphased trial, this study offers patients the opportunity to contribute to groundbreaking research that could improve future treatment options.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Kaneka i-ED Coil System is safe for treating brain aneurysms?

Research has shown that the Kaneka i-ED Coil System is designed to treat brain aneurysms and has been tested for safety in both ruptured and unruptured cases. Past patients demonstrated that it can effectively seal aneurysms, sometimes using fewer coils, which might reduce complications and improve safety.

Other studies used this system on aneurysms between 4mm and 14mm in size. Patients treated with this system required no changes to the usual procedure for endovascular coiling, suggesting it fits well with current practices.

While detailed information on side effects remains limited, the ongoing trials indicate a reasonable belief in its safety. These trials help ensure the treatment is as safe as possible before wider use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Kaneka i-ED Coil is unique because it offers a new approach to treating brain aneurysms through endovascular coiling. Unlike traditional coils that are often made from platinum, the Kaneka i-ED Coil is designed to improve the way the coil packs into the aneurysm, potentially leading to more effective stabilization and reduced risk of rupture. Researchers are excited about this treatment because it could enhance the precision and safety of aneurysm embolization, providing better outcomes for patients compared to conventional coiling methods.

What evidence suggests that the Kaneka i-ED Coil System is effective for brain aneurysms?

Research has shown that the Kaneka i-ED Coil System, which participants in this trial may receive, effectively treats brain aneurysms. Early results suggest it works well for aneurysms of various sizes and shapes. The i-ED coils fill the aneurysm, stopping blood flow and preventing it from bursting. Studies have found these coils to be safe and effective both immediately after treatment and over time. This treatment shows particular promise for wide-necked aneurysms, which are typically more challenging to treat. ^{1 4 5 6 7}

Who Is on the Research Team?

Reade De Leacy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My aneurysm is between 6 and 14 mm wide.

The patient has not been previously enrolled in this trial or another related ongoing trial

My aneurysm has not been treated before.

Exclusion Criteria

My aneurysm was previously treated with coils or surgery.

I have multiple aneurysms but only one meets the specific treatment criteria.

My condition is severe after a brain hemorrhage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Kaneka iED coil for endovascular aneurysm coiling

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Multiple visits over 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Kaneka iED Coil System

Trial Overview 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.

How Is the Trial Designed?

Group I: Kaneka i-ED coil Experimental Treatment 1 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 embolization Active Control 1 Intervention

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

Kaneka iED Coil System is already approved in United States, Japan for the following indications:

Approved in United States as Kaneka i-ED Coil System for:

• Endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• Vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation
• Arterial and venous embolizations in the peripheral vasculature

Approved in Japan as i-ED Coil for:

• Embolization of brain aneurysms

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Kaneka Corporation

Industry Sponsor

Trials

7

Recruited

530+

Published Research Related to This Trial

The Kaneda anterior spinal system demonstrated a 71% average correction rate for thoracic scoliosis in a study of 20 patients, with significant improvements in trunk shift and kyphosis after surgery.

The technique effectively corrected rigid rotational deformities, achieving a 58% correction rate when rib head joints were resected, although caution is advised to prevent lumbar curve decompensation, particularly in patients with Type II curves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior correction of thoracic scoliosis with Kaneda anterior spinal system. A preliminary report. Kaneda, K., Shono, Y., Satoh, S., et al.[2022]

Endovascular coiling significantly reduces intra-aneurysmal blood flow velocity and wall shear stress, especially with lower packing densities, indicating its effectiveness in altering hemodynamics in treated aneurysms.

As packing density increases, the influence of coil configuration on hemodynamics diminishes, suggesting that higher packing densities may lead to more consistent outcomes regardless of coil arrangement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do coil configuration and packing density influence intra-aneurysmal hemodynamics? Morales, HG., Kim, M., Vivas, EE., et al.[2021]

In a study of 92 cerebral aneurysms treated with the ED coil-10 Extra Soft (EDC-10 ES), 68.5% achieved complete occlusion immediately after embolization, which improved to 78.3% at the 6-month follow-up, demonstrating the coil's efficacy.

The procedure had a low complication rate of 3.3%, and the overall recurrence rate of aneurysms was 10.0%, indicating that the EDC-10 ES is a safe option for embolization with effective long-term results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with an extremely soft bare platinum coil, ED coil-10 Extra Soft, for endovascular treatment of cerebral aneurysms. Harada, K., Morioka, J.[2022]

Stent-assisted coiling (SAC) for treating complex unruptured intracranial aneurysms (UIA) showed a high success rate with 100% embolization success and low complication rates (2.2% morbidity and 0% mortality) over a 9-year period involving 164 patients.

Long-term follow-up (average 26 months) revealed a significant improvement in occlusion rates, with 75.9% of patients achieving complete occlusion, indicating that SAC is an effective and safe treatment option for complex UIAs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stent-assisted coiling of unruptured intracranial aneurysms: long-term follow-up in 164 patients with 183 aneurysms. Mine, B., Aljishi, A., D'Harcour, JB., et al.[2019]

Stent-assisted coiling for treating intracranial aneurysms significantly reduces the rate of angiographic recurrence (15.5% with stents vs. 35.5% without), making it an effective option for preventing reformation of aneurysms.

However, this technique is associated with higher complication rates, including a 9.4% overall complication rate and increased ischemic (7.0% vs. 3.5%) and mortality risks (2.7% vs. 1.1%) compared to coiling without stents, particularly in patients with wide-neck aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of complications and recurrences of aneurysm coiling with special emphasis on the stent-assisted technique. Nishido, H., Piotin, M., Bartolini, B., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05636124

Kaneka iED Coil System for the Treatment of Wide Necked ... Cost Effectiveness, Safety, and Efficacy of the Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms.

2. trialx.com trialx.com/clinical-trials/listings/273038/kaneka-endovascular-embolization-and-protection/

Kaneka Endovascular Embolization and Protection Assess and describe real world clinical data on i-ED coils Characterize the acute and long-term performance of iED coils when used for treating for an ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37151447/

Low-memory shape coils for intracranial aneurysm coiling Our initial experience with i-ED coils has shown that they are a feasible strategy in a number of differently sized and shaped aneurysms.

4. withpower.com withpower.com/trial/phase-aneurysm-2023-f2944

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

5. kanekanv.com kanekanv.com/clinicaldata

Clinical — Kaneka Neurovascular USA The study objective is to assess and describe real world clinical data on i-ED coils. Characterize the acute and long-term performance of i-ED Coils when used ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05563051

Kaneka Endovascular Embolization and Protection Target aneurysm of 4mm - 14mm in size; Ruptured or unruptured; Suitable for embolization with coils; May be treated with or without assist devices. Exclusion ...

7. kanekanv.com kanekanv.com/i-ed-coil-systems

i-ED Coil System - Kaneka The i-ED COIL System (i-ED COIL and EDG v4) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such ...