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

Running, not enrolling · Not applicable

Conditions studied: Intracranial Aneurysms, Wide Neck Intracranial Aneurysms

In brief

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.

Key facts

Study ID

NCT05636124

Run by

Icahn School of Medicine at Mount Sinai

People needed

50

Starts

2023-06-02

Expected to finish

2027-07-01

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Sutter Health — Danville, California, United States
• Baptist Health Jacksonville — Jacksonville, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Prisma Health — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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