Kaneka IED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Nov 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method using the Kaneka IED Coil System for patients with wide necked intracranial aneurysms, which are bulges in blood vessels in the brain that can be either ruptured or unruptured. The research aims to evaluate how safe and effective this treatment is, as well as its cost-effectiveness, over an 18-month period. The trial is currently looking for participants aged 18 to 80 who have a specific type of aneurysm that is suitable for this endovascular treatment, which is a less invasive procedure that involves placing coils in the aneurysm to help seal it off.

To be eligible for the trial, participants must have an aneurysm that meets certain size and shape criteria and must be able to provide informed consent for the procedure. This means that they understand the treatment and agree to take part. Participants should expect to undergo the treatment and then return for follow-up evaluations to see how well the treatment is working at specific intervals. It's important to note that this study is focused on patients who have not previously received treatment for their aneurysm and who do not have severe health issues that would affect their life expectancy.

Gender

ALL

Eligibility 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

Trial Officials