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

Mount Sinai Health System

Status: Enrolling

Conditions: Wide Neck Intracranial Aneurysms; Intracranial Aneurysms

Treatments: Device: Kaneka i-ED coil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05636124

STUDY-22-01480

Details and patient eligibility

About

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.

Full description

Although coiling has become the most common form of treatment for intracranial aneurysms, there is evidence to suggest that the cost of coiling is on average 50% greater than the cost of clipping. Device costs represent the majority of this increased financial burden. This issue has only increased over time, as supplies and devices accounted for 24% of the increase in hospital costs per discharge from 2001 to 2006. The list price of coils on the US market ranges from $500 to $3000, thus small changes in the number of coils used per case can result in a large cost saving. The Kaneka iED coil is priced within this normal range, but offers a multi-diameter design that may reduce the number of coils required to achieve adequate embolization.

Aside from potential cost savings across all aneurysm types, the ability of the Kaneka iED to both frame and fill with a single coil may prove particularly effective in the treatment of wide-necked aneurysms. In these cases, a wide neck at the base of the aneurysm increased the risk for protrusion of the coil mass back into the normal lumen of the vessel, which can result in stroke and other severe complications. Adjunctive devices such as balloon and stents are often employed to reconstruct the aneurysm neck in these cases, and larger coil mass provided by the Kaneka iED may additionally serve to decrease the risk of coil protrusion.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Kaneka i-ED coil

Experimental group

Description:

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.

Treatment:

Device: Kaneka i-ED coil

Matched patients who underwent intracranial aneurysm embolization

No Intervention group

Description:

The comparator arm will be comprised of propensity matched patients who underwent intracranial aneurysm embolization as part of the FEAT Trial (NCT01655784).