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OpenTrials
Active, Not Recruiting

NCT Number: NCT05563051

Kaneka Endovascular Embolization and Protection

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McLaren Health Care, Grand Blanc, Michigan, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

i-ED COIL

Device

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

Primary outcomes

  1. Adequate Occlusion

    Time frame: 12 months

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

Secondary outcomes

  1. Complete Occlusion

    Time frame: 12 months

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

  2. Packing Density

    Time frame: 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

    Time frame: 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

    Time frame: 12 months

    Any retreatment of the aneurysm, surgically or interventional embolization

  5. Adverse events

    Time frame: 12 months

    Device or procedure related adverse events

Sponsors and collaborators

Lead sponsor

Kaneka Medical America LLC

Industry

Registry information

Acronym: KEEP

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2022
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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