Kaneka i-ED Coil for Brain Aneurysm
(CLASS Trial)
Recruiting at 4 trial locations
NS
SD
SE
Overseen BySydney Edwards
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries
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?
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.
See 6 more
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.
See 2 more
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
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
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).
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
Find a Clinic Near You
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+
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]
References
Anterior correction of thoracic scoliosis with Kaneda anterior spinal system. A preliminary report. [2022]
Initial experience with an extremely soft bare platinum coil, ED coil-10 Extra Soft, for endovascular treatment of cerebral aneurysms. [2022]
Stent-assisted coiling of unruptured intracranial aneurysms: long-term follow-up in 164 patients with 183 aneurysms. [2019]
Analysis of complications and recurrences of aneurysm coiling with special emphasis on the stent-assisted technique. [2022]
How do coil configuration and packing density influence intra-aneurysmal hemodynamics? [2021]
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