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

Last updated: October 23, 2024
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

Kaneka i-ED coil

Clinical Study ID

NCT05636124
STUDY-22-01480
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

Inclusion criteria:

  • Patient presenting with ruptured or unruptured cerebral aneurysm appropriate forendovascular treatment as determined by the neuroendovascular treating team

  • Wide neck side wall or bifurcation intracranial aneurysms (neck > or = to 4 mm ordome-to-neck ratio < 2) within the anterior or posterior circulation

  • The neurointerventionist feels that the aneurysm can be safely treated usingendovascular 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 thepatient cannot consent for themselves, appropriate written consent has been soughtfrom 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 imagingevaluation (angiography) at 3-6 months and 12-18 months after endovascular treatment

  • The patient has not been previously enrolled in this trial or another relatedongoing trial

  • The aneurysm has not been previously treated by coiling or clipping

Exclusion

Exclusion criteria:

  • Patient has more than one aneurysm requiring treatment in the current treatmentsession, and only one of those to be treated aneurysms fits the Kaneka inclusioncriteria (i.e., - if either (1) a patient has multiple aneurysms, but only one willbe treated at enrollment; or (2) if two or more aneurysms are treated during thecurrent treatment session and BOTH are able to be enrolled, then they remaineligible for the trial). Non-treated additional aneurysms may be treated at a laterdate 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

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Kaneka i-ED coil
Phase:
Study Start date:
June 02, 2023
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Sutter Health

    Danville, California 94526
    United States

    Active - Recruiting

  • Baptist Health Jacksonville

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Prisma Health

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

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