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

Description

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.

Conditions

Intracranial Aneurysms, Wide Neck Intracranial Aneurysms

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Study Overview

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Study Details

Study overview

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.

Cost Effectiveness, Safety, and Efficacy of the Kaneka IED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms

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

Condition
Intracranial Aneurysms
Intervention / Treatment

-

Contacts and Locations

Danville

Sutter Health, Danville, California, United States, 94526

Jacksonville

Baptist Health Jacksonville, Jacksonville, Florida, United States, 32207

Tampa

University of South Florida, Tampa, Florida, United States, 33606

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Greenville

Prisma Health, Greenville, South Carolina, United States, 29605

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Icahn School of Medicine at Mount Sinai,

Reade De Leacy, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

2025-07