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

NCT05636124 | Active Not Recruiting FDA Device

• 1 other identifier: STUDY-22-01480
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Intracranial Aneurysms; Wide Neck Intracranial Aneurysms

Outcome Measures

Primary Outcomes (5)

• Number of patients with Modified Raymond Roy 1-2 Occlusion classification without retreatment

  Modified Raymond Roy 1-2 occlusion at 18 months without retreatment. The Raymond-Roy Occlusion Classification has 3 responses, where Grade 1 is complete occlusion, no flow of contrast seen in the sac, Grade 2 is partial occlusion, some flow in the neck or sac, and Grade 3 is incomplete occlusion, apparent flow into the sac. Grade 1 indicates the best outcome.

  at 18 months

• Number of coils used

  Number of coils used to assess treatment-related cost effectiveness at treatment and over the course of follow-up to 18 months.

  up to 18 months post-treatment

• Packing density of coils

  Packing density of coils used to assess treatment-related cost effectiveness at treatment and over the course of follow-up to 18 months.

  up to 18 months post-treatment

• Number of device related serious adverse events

  Intra and peri-procedural (0-24 hours) device related serious adverse event rate.

  up to 24 hours

• Number of device related serious adverse events

  Intra and peri-procedural (24 hours to 30 days) device related serious adverse event rate.

  24 hours to 30 days

Secondary Outcomes (12)

• Rate of complete or near complete aneurysm occlusion without retreatment

  at 6 months

• Number of patients with Modified Raymond-Roy classification 1

  at 18 months

• Number of patients who suffer a Major ipsilateral stroke or neurological death

  at 6 months

• Number of patients who suffer a Major ipsilateral stroke or neurological death

  at 18 months

• Changes in Modified Rankin Scale (mRS) score

  Day 30, 6 months, and 12-18 months

Study Arms (2)

Kaneka i-ED coil

EXPERIMENTAL

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.

Device: Kaneka i-ED coil

Matched patients who underwent intracranial aneurysm embolization

NO INTERVENTION

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

Interventions

Kaneka i-ED coil DEVICE

The study device is the Kaneka i-ED coil T, FDA cleared under 510K number K192068. The coil is indicated for use in the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

Kaneka i-ED coil

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Kaneka Corporation: collaborator

Study Sites (5)

Sutter Health

Danville, California, 94526, United States

Location

Baptist Health Jacksonville

Jacksonville, Florida, 32207, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Related Publications (3)

• Gandhoke GS, Pandya YK, Jadhav AP, Jovin T, Friedlander RM, Smith KJ, Jankowitz BT. Cost of coils for intracranial aneurysms: clinical decision analysis for implementation of a capitation model. J Neurosurg. 2018 Jun;128(6):1792-1798. doi: 10.3171/2017.3.JNS163149. Epub 2017 Aug 25.

  PMID: 28841115 BACKGROUND

• Bairstow P, Dodgson A, Linto J, Khangure M. Comparison of cost and outcome of endovascular and neurosurgical procedures in the treatment of ruptured intracranial aneurysms. Australas Radiol. 2002 Sep;46(3):249-51. doi: 10.1046/j.1440-1673.2002.01053.x.

  PMID: 12196230 BACKGROUND

• Maeda JL, Raetzman SO, Friedman BS. What hospital inpatient services contributed the most to the 2001-2006 growth in the cost per case? Health Serv Res. 2012 Oct;47(5):1814-35. doi: 10.1111/j.1475-6773.2012.01460.x. Epub 2012 Sep 4.

  PMID: 22946883 BACKGROUND

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Reade De Leacy

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Neurosurgery

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 5, 2022
• Study Start: June 2, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)