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

ID#: NCT05636124

Age: 18 - 80 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: June 02, 2023

End Date: July 01, 2025

Contact Information:
Sydney Edwards
212 241 2524
Sukaina Davdani
(212) 241-1497
Summary: This is a multi-center, prospective, propensity matched twin armed study conducted on 50 patients in the experimental arm followed for 18 months after intervention evaluating cost effectiveness, safety and efficacy of therapy.
Eligibility:

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
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