Kaneka iED Coil for treating wide necked intracranial aneurysms
Cost Effectiveness, Safety, and Efficacy of the Kaneka IED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
This study is testing a new coil treatment for wide necked brain aneurysms to see if it can safely help patients better than the usual methods while also being more cost-effective.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 5 sites (Danville, California and 4 other locations) |
| Trial ID | NCT05636124 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the Kaneka iED coil system for the treatment of both ruptured and unruptured wide necked intracranial aneurysms. It is a multi-center, prospective study involving 50 patients, focusing on the cost-effectiveness, safety, and efficacy of the therapy over an 18-month follow-up period. The Kaneka iED coil is designed to reduce the number of coils needed for effective embolization, potentially lowering treatment costs and minimizing complications associated with coil protrusion. The study aims to determine if this innovative approach can improve patient outcomes compared to traditional coiling methods.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with wide necked intracranial aneurysms suitable for endovascular treatment.
Not a fit: Patients with aneurysms not meeting the size or neck criteria, or those with severe comorbidities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more cost-effective option for patients with wide necked intracranial aneurysms.
How similar studies have performed: Other studies have shown promise in using innovative coiling techniques for aneurysm treatment, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neuroendovascular treating team * Wide neck side wall or bifurcation intracranial aneurysms (neck \> or = to 4 mm or dome-to-neck ratio \< 2) within the anterior or posterior circulation * The neurointerventionist feels that the aneurysm can be safely treated using endovascular techniques (direct or assisted coiling) * Patients are 18-80 years of age (inclusive) * Patient must be Hunt and Hess grade 0 to 3 * Patient has given fully informed consent to endovascular coiling procedure. If the patient cannot consent for themselves, appropriate written consent has been sought from their next of kin or appropriate power of attorney. * Aneurysm 6-14 mm in diameter * Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography) at 3-6 months and 12-18 months after endovascular treatment * The patient has not been previously enrolled in this trial or another related ongoing trial * The aneurysm has not been previously treated by coiling or clipping Exclusion criteria: * Patient has more than one aneurysm requiring treatment in the current treatment session, and only one of those to be treated aneurysms fits the Kaneka inclusion criteria (i.e., - if either (1) a patient has multiple aneurysms, but only one will be treated at enrollment; or (2) if two or more aneurysms are treated during the current treatment session and BOTH are able to be enrolled, then they remain eligible for the trial). Non-treated additional aneurysms may be treated at a later date with any coil type that the operator chooses). * Target aneurysm has had previous coil treatment or has been surgically clipped * Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage * Inability to obtain informed consent * Medical or surgical comorbidity such that the patient's life expectancy is less than 2 years
Where this trial is running
Danville, California and 4 other locations
- Sutter Health — Danville, California, United States (Recruiting)
- Baptist Health Jacksonville — Jacksonville, Florida, United States (Recruiting)
- University of South Florida — Tampa, Florida, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- Prisma Health — Greenville, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Reade De Leacy — Icahn School of Medicine at Mount Sinai
- Study coordinator: Sydney Edwards
- Email: sydney.edwards@mountsinai.org
- Phone: 212 241 2524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.