Kaneka i-ED Coil for Brain Aneurysm

(CLASS Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Reade De Leacy, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Multiple aneurysms, Previous coil, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this 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 aneurysms, by using fewer coils to seal the aneurysm, which could lower costs and improve safety.

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.

How is the Kaneka i-ED Coil treatment for brain aneurysms different from other treatments?

The Kaneka i-ED Coil System is unique because it uses an extremely soft coil, which offers excellent operability for embolization (blocking blood flow) of cerebral aneurysms, making it particularly effective as a 'finishing coil' to ensure complete treatment. ^{1 2 3 4 5}

Research Team

Reade De Leacy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Kaneka iED Coil System (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.

Participant Groups

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 Japan for the following indications:

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+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

Kaneka Corporation

Industry Sponsor

Trials

7

Recruited

530+

Findings from Research

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]

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]

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]

References

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

Anterior correction of thoracic scoliosis with Kaneda anterior spinal system. A preliminary report. [2022]

2. England 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. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Stent-assisted coiling of unruptured intracranial aneurysms: long-term follow-up in 164 patients with 183 aneurysms. [2019]

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

Analysis of complications and recurrences of aneurysm coiling with special emphasis on the stent-assisted technique. [2022]

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

How do coil configuration and packing density influence intra-aneurysmal hemodynamics? [2021]