Aneurysm CerebralKEEPNCT05563051
Kaneka Endovascular Embolization and Protection
A study testing i-ED COIL in people with Aneurysm Cerebral, run by Kaneka Medical America LLC at 4 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aneurysm Cerebral
- What is being tested?
- i-ED COIL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Dec 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Target aneurysm of 4mm - 14mm in size
- Ruptured or unruptured
- Suitable for embolization with coils
- May be treated with or without assist devices
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cleveland Clinic
Cleveland, Ohio, 44195
McLaren Health Care
Grand Blanc, Michigan, 48439
Northwell Health Lenox Hill Hospital
New York, New York, 10075
SSM Health St. Anthony's Hospital
Oklahoma City, Oklahoma, 73102
About this study
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
Read the 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
- Conditions
- Aneurysm Cerebral
- Being tested
- i-ED COIL
- Keywords
- aneurysm, coil, i-ED COIL, embolization, neuro endovascular
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-ED COILDevice
Also called Embolic coils, Embolization coils
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional treatment | Other | Open label Receives: Device: i-ED COIL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate Occlusion
Proportion of subjects who achieve Adequate Occlusion (Modified Raymond-Roy I or II Classification)
Measured: 12 months
Secondary outcomes (5)
Complete Occlusion
Complete occlusion at 1 year (Modified Raymond-Roy I)
Measured: 12 months
Packing Density
Aneurysm volume and percent of aneurysm packing for coil embolization. Packing density will be evaluated based on aneurysm volume and coil volume
Measured: 12 months
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
Measured: 12 months
Retreatment
Any retreatment of the aneurysm, surgically or interventional embolization
Measured: 12 months
Adverse events
Device or procedure related adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start13 Dec 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm CerebralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaneka Medical America LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ajit Puri, MD, Principal investigator, University of Massachusetts, WorcesterMohamed Hussain, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563051
- Sponsor's protocol ID
- KMA-IVRNV-001
- Acronym
- KEEP
- Status last verified
- Oct 2025
- First submitted
- 28 Sep 2022
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kaneka Endovascular Embolization and Protection
- ClinicalTrials.gov ID
- NCT05563051
- Acronym / sponsor ID
- KEEP / KMA-IVRNV-001
- Conditions
- Aneurysm Cerebral
- Keywords
- aneurysm, coil, i-ED COIL, embolization, neuro endovascular
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Kaneka Medical America LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional treatment | Other | Device: i-ED COILOpen label |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Target aneurysm of 4mm - 14mm in size
- Ruptured or unruptured
- Suitable for embolization with coils
- May be treated with or without assist devices
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| i-ED COILAlso: Embolic coils, Embolization coilsThe 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. | Device | Interventional treatment |
Primary outcome
Adequate Occlusion
Time frame: 12 months
Proportion of subjects who achieve Adequate Occlusion (Modified Raymond-Roy I or II Classification)
5 secondary outcomes
Complete Occlusion
Time frame: 12 months
Packing Density
Time frame: 12 months
Modified Rankin Score
Time frame: 12 months
Retreatment
Time frame: 12 months
Adverse events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajit Puri, MD principal investigator
University of Massachusetts, Worcester
Mohamed Hussain, MD principal investigator
The Cleveland Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-ED COIL in people with Aneurysm Cerebral, run by Kaneka Medical America LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate Occlusion (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.