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KEEP: Kaneka Endovascular Embolization and Protection

Sponsor
Kaneka Medical America LLC (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05563051
Collaborator
(none)
164
Enrollment
1
Arm
36
Anticipated Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Device: i-ED COIL
 N/A

Detailed 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
164 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Kaneka Endovascular Embolization and Protection
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Interventional treatment

Open label

Device: i-ED COIL
The i-ED COIL System (i-ED COIL and detachment box) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Other Names:
  • Embolic coils
  • Embolization coils

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adequate Occlusion [12 months]

      Proportion of subjects who achieve Adequate Occlusion (Modified Raymond-Roy I or II Classification)

    Secondary Outcome Measures

    1. Complete Occlusion [12 months]

      Complete occlusion at 1 year (Modified Raymond-Roy I)

    2. Packing Density [12 months]

      Aneurysm volume and percent of aneurysm packing for coil embolization. Packing density will be evaluated based on aneurysm volume and coil volume

    3. Modified Rankin Score [12 months]

      Modified Rankin Score (Scale from 0-6), the lower the score the better - 0 No symptoms and 6 is dead. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead

    4. Retreatment [12 months]

      Any retreatment of the aneurysm, surgically or interventional embolization

    5. Adverse events [12 months]

      Device or procedure related adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 Criteria:

    • Unstable neurological deficit in unruptured cases (condition worsening within last 90 days)

    • 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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Kaneka Medical America LLC

    Investigators

    • Principal Investigator: Ajit Puri, MD, University of Massachusetts, Worcester
    • Principal Investigator: Mohamed Hussain, MD, The Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kaneka Medical America LLC
    ClinicalTrials.gov Identifier:
    NCT05563051
    Other Study ID Numbers:
    • KMA-IVRNV-001
    First Posted:
    Oct 3, 2022
    Last Update Posted:
    Oct 14, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Aneurysm

    Study Results

    No Results Posted as of Oct 14, 2022