Kaneka Endovascular Embolization and Protection

Last updated: March 4, 2024
Sponsor: Kaneka Medical America LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

i-ED COIL

Clinical Study ID

NCT05563051
KMA-IVRNV-001
  • Ages 18-80
  • All Genders

Study Summary

Prospective, multi-center, non-randomized registry / study, up to 164 patients enrolled and followed at 180 days +/- 45 days and again at 365 days +/- 90 days post procedure

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Target aneurysm of 4mm - 14mm in size
  • Ruptured or unruptured
  • Suitable for embolization with coils
  • May be treated with or without assist devices

Exclusion

Exclusion Criteria:

  • Unstable neurological deficit in unruptured cases (condition worsening within last 90days)
  • Pre-planned staged procedure of target aneurysm
  • mRS score 3 or more
  • Hunt Hess Score more than 3 for subjects with ruptured aneurysm
  • Evidence of active infection (e.g.,fever, temperature >38 degrees C and/or WBC >15,000)

Study Design

Total Participants: 164
Treatment Group(s): 1
Primary Treatment: i-ED COIL
Phase:
Study Start date:
December 13, 2022
Estimated Completion Date:
October 31, 2025

Study Description

Assess and describe real world clinical data on i-ED coils Characterize the acute and long-term performance of iED coils when used for treating for an intracranial aneurysm May be used alone or in combination with other adjunctive device(s)

Study Duration

Anticipated timeline for study:

Patient enrollment in 18 - 24 months Completion of follow-up 12 months after last patient enrolled

Connect with a study center

  • McLaren Health Care

    Grand Blanc, Michigan 48439
    United States

    Active - Recruiting

  • Northwell Health Lenox Hill Hospital

    New York, New York 10075
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • SSM Health St. Anthony's Hospital

    Oklahoma City, Oklahoma 73102
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.