search
Back to results

Kaneka Endovascular Embolization and Protection (KEEP)

Primary Purpose

Aneurysm Cerebral

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
i-ED COIL
Sponsored by
Kaneka Medical America LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aneurysm Cerebral focused on measuring aneurysm, coil, i-ED COIL, embolization, neuro endovascular

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • McLaren Health CareRecruiting
  • Northwell Health Lenox Hill HospitalRecruiting
  • Cleveland ClinicRecruiting
  • SSM Health St. Anthony's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Interventional treatment

Arm Description

Open label

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Complete Occlusion
Complete occlusion at 1 year (Modified Raymond-Roy I)
Packing Density
Aneurysm volume and percent of aneurysm packing for coil embolization. Packing density will be evaluated based on aneurysm volume and coil volume
Modified Rankin Score
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
Retreatment
Any retreatment of the aneurysm, surgically or interventional embolization
Adverse events
Device or procedure related adverse events

Full Information

First Posted
September 28, 2022
Last Updated
March 17, 2023
Sponsor
Kaneka Medical America LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT05563051
Brief Title
Kaneka Endovascular Embolization and Protection
Acronym
KEEP
Official Title
Kaneka Endovascular Embolization and Protection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaneka Medical America LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm Cerebral
Keywords
aneurysm, coil, i-ED COIL, embolization, neuro endovascular

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional treatment
Arm Type
Other
Arm Description
Open label
Intervention Type
Device
Intervention Name(s)
i-ED COIL
Other Intervention Name(s)
Embolic coils, Embolization coils
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adequate Occlusion
Description
Proportion of subjects who achieve Adequate Occlusion (Modified Raymond-Roy I or II Classification)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Complete Occlusion
Description
Complete occlusion at 1 year (Modified Raymond-Roy I)
Time Frame
12 months
Title
Packing Density
Description
Aneurysm volume and percent of aneurysm packing for coil embolization. Packing density will be evaluated based on aneurysm volume and coil volume
Time Frame
12 months
Title
Modified Rankin Score
Description
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
Time Frame
12 months
Title
Retreatment
Description
Any retreatment of the aneurysm, surgically or interventional embolization
Time Frame
12 months
Title
Adverse events
Description
Device or procedure related adverse events
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuki Arimoto
Phone
3475253625
Email
yuki.arimoto@kaneka.com
First Name & Middle Initial & Last Name or Official Title & Degree
Akihiro Dozono
Phone
2127054365
Email
NV.Clinical@kaneka.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajit Puri, MD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Hussain, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLaren Health Care
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwell Health Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
SSM Health St. Anthony's Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Kaneka Endovascular Embolization and Protection

We'll reach out to this number within 24 hrs