Kaneka Endovascular Embolization and Protection
KEEP
1 other identifier
interventional
164
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2022
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2022
CompletedFirst Posted
Study publicly available on registry
October 3, 2022
CompletedStudy Start
First participant enrolled
December 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedOctober 7, 2025
October 1, 2025
3 years
September 28, 2022
October 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adequate Occlusion
Proportion of subjects who achieve Adequate Occlusion (Modified Raymond-Roy I or II Classification)
12 months
Secondary Outcomes (5)
Complete Occlusion
12 months
Packing Density
12 months
Modified Rankin Score
12 months
Retreatment
12 months
Adverse events
12 months
Study Arms (1)
Interventional treatment
OTHEROpen label
Interventions
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.
Eligibility Criteria
You may qualify if:
- Target aneurysm of 4mm - 14mm in size
- Ruptured or unruptured
- Suitable for embolization with coils
- May be treated with or without assist devices
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
McLaren Health Care
Grand Blanc, Michigan, 48439, United States
Northwell Health Lenox Hill Hospital
New York, New York, 10075, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
SSM Health St. Anthony's Hospital
Oklahoma City, Oklahoma, 73102, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ajit Puri, MD
University of Massachusetts, Worcester
- PRINCIPAL INVESTIGATOR
Mohamed Hussain, MD
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2022
First Posted
October 3, 2022
Study Start
December 13, 2022
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
October 7, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share