Intracranial AneurysmsCLASSNCT05636124
Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
A study testing Kaneka i-ED coil in people with Intracranial Aneurysms and Wide Neck Intracranial Aneurysms, run by Icahn School of Medicine at Mount Sinai at 5 sites in United States.
Trial summary
This is a multi-center, prospective, propensity matched twin armed study conducted on 50 patients in the experimental arm followed for 18 months after intervention evaluating cost effectiveness, safety and efficacy of therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysms, Wide Neck Intracranial Aneurysms
- What is being tested?
- Kaneka i-ED coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- 2 Jun 2023to Jul 2027
- 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
- Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neuroendovascular treating team
- Wide neck side wall or bifurcation intracranial aneurysms (neck > or = to 4 mm or dome-to-neck ratio < 2) within the anterior or posterior circulation
- The neurointerventionist feels that the aneurysm can be safely treated using endovascular techniques (direct or assisted coiling)
- Patients are 18-80 years of age (inclusive)
- Patient must be Hunt and Hess grade 0 to 3
- Patient has given fully informed consent to endovascular coiling procedure. If the patient cannot consent for themselves, appropriate written consent has been sought from their next of kin or appropriate power of attorney.
Show all 10Show fewer
- Aneurysm 6-14 mm in diameter
- Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography) at 3-6 months and 12-18 months after endovascular treatment
- The patient has not been previously enrolled in this trial or another related ongoing trial
- The aneurysm has not been previously treated by coiling or clipping
Who cannot join
- Patient has more than one aneurysm requiring treatment in the current treatment session, and only one of those to be treated aneurysms fits the Kaneka inclusion criteria (i.e., - if either (1) a patient has multiple aneurysms, but only one will be treated at enrollment; or (2) if two or more aneurysms are treated during the current treatment session and BOTH are able to be enrolled, then they remain eligible for the trial). Non-treated additional aneurysms may be treated at a later date with any coil type that the operator chooses).
- Target aneurysm has had previous coil treatment or has been surgically clipped
- Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage
- Inability to obtain informed consent
- Medical or surgical comorbidity such that the patient's life expectancy is less than 2 years
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Sutter Health
Danville, California, 94526
Prisma Health
Greenville, South Carolina, 29605
Baptist Health Jacksonville
Jacksonville, Florida, 32207
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of South Florida
Tampa, Florida, 33606
About this study
Official title: Cost Effectiveness, Safety, and Efficacy of the Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
This is a multi-center, prospective, propensity matched twin armed study conducted on 50 patients in the experimental arm followed for 18 months after intervention evaluating cost effectiveness, safety and efficacy of therapy.
Read the detailed description
Although coiling has become the most common form of treatment for intracranial aneurysms, there is evidence to suggest that the cost of coiling is on average 50% greater than the cost of clipping. Device costs represent the majority of this increased financial burden. This issue has only increased over time, as supplies and devices accounted for 24% of the increase in hospital costs per discharge from 2001 to 2006. The list price of coils on the US market ranges from $500 to $3000, thus small changes in the number of coils used per case can result in a large cost saving. The Kaneka iED coil is priced within this normal range, but offers a multi-diameter design that may reduce the number of coils required to achieve adequate embolization.
Aside from potential cost savings across all aneurysm types, the ability of the Kaneka iED to both frame and fill with a single coil may prove particularly effective in the treatment of wide-necked aneurysms. In these cases, a wide neck at the base of the aneurysm increased the risk for protrusion of the coil mass back into the normal lumen of the vessel, which can result in stroke and other severe complications. Adjunctive devices such as balloon and stents are often employed to reconstruct the aneurysm neck in these cases, and larger coil mass provided by the Kaneka iED may additionally serve to decrease the risk of coil protrusion.
- Being tested
- Kaneka i-ED coil
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaneka i-ED coilDevice
The study device is the Kaneka i-ED coil T, FDA cleared under 510K number K192068. The coil is indicated for use in the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
| Study group | Role | What they receive |
|---|---|---|
| Kaneka i-ED coil | Experimental | Patients in the experimental arm will be treated according to the standard of care for endovascular aneurysm coiling, with no procedural modifications related to the use of the experimental device. Receives: Device: Kaneka i-ED coil |
| Matched patients who underwent intracranial aneurysm embolization | No intervention | The comparator arm will be comprised of propensity matched patients who underwent intracranial aneurysm embolization as part of the FEAT Trial (NCT01655784). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Modified Raymond Roy 1-2 Occlusion classification without retreatment
Modified Raymond Roy 1-2 occlusion at 18 months without retreatment. The Raymond-Roy Occlusion Classification has 3 responses, where Grade 1 is complete occlusion, no flow of contrast seen in the sac, Grade 2 is partial occlusion, some flow in the neck or sac, and Grade 3 is incomplete occlusion, apparent flow into the sac. Grade 1 indicates the best outcome.
Measured: at 18 months
Number of coils used
Number of coils used to assess treatment-related cost effectiveness at treatment and over the course of follow-up to 18 months.
Measured: up to 18 months post-treatment
Packing density of coils
Packing density of coils used to assess treatment-related cost effectiveness at treatment and over the course of follow-up to 18 months.
Measured: up to 18 months post-treatment
Number of device related serious adverse events
Intra and peri-procedural (0-24 hours) device related serious adverse event rate.
Measured: up to 24 hours
Number of device related serious adverse events
Intra and peri-procedural (24 hours to 30 days) device related serious adverse event rate.
Measured: 24 hours to 30 days
Secondary outcomes (12)
Rate of complete or near complete aneurysm occlusion without retreatment
Rate of complete or near complete aneurysm occlusion without retreatment at 6 months
Measured: at 6 months
Number of patients with Modified Raymond-Roy classification 1
The Raymond-Roy Occlusion Classification has 3 responses, where Grade 1 is complete occlusion, no flow of contrast seen in the sac, Grade 2 is partial occlusion, some flow in the neck or sac, and Grade 3 is incomplete occlusion, apparent flow into the sac. Grade 1 indicates the best outcome.
Measured: at 18 months
Number of patients who suffer a Major ipsilateral stroke or neurological death
Number of patients who suffer a Major ipsilateral stroke or neurological death. A major ipsilateral stroke is defined as that occurring within the vascular distribution of the stented artery. Neurologic death is defined as a death which has been adjudicated by the independent clinical events committee to have directly resulted from a neurologic cause.
Measured: at 6 months
Number of patients who suffer a Major ipsilateral stroke or neurological death
Number of patients who suffer a Major ipsilateral stroke or neurological death. A major ipsilateral stroke is defined as that occurring within the vascular distribution of the stented artery. Neurologic death is defined as a death which has been adjudicated by the independent clinical events committee to have directly resulted from a neurologic cause.
Measured: at 18 months
Changes in Modified Rankin Scale (mRS) score
The mRS ranges from 0 to 6, with higher scores indicating a greater degree of disability or dependence. Scores will be assigned based on the following:
0 - no symptoms, 1 - no significant disability, able to carry out all usual activities despite some symptoms, 2 - slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 - moderate disability, requires some help, but able to walk unassisted, 4 - moderately severe disability, unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 - severe disability, requires constant nursing care and attention, bedridden, incontinent, 6 - deceased.
Changes in the mRS score will be assessed between day 30, 6 months, and 12-18 months.
Measured: Day 30, 6 months, and 12-18 months
Changes in National Institutes of Health Stroke Scale (NIHSS) score
The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The total NIHSS score can range from 0 to 42, with 0 indicating no stroke symptoms and 42 indicating extremely severe stroke symptoms. So, a higher NIHSS score indicates a greater degree of impairment. Changes in the NIHSS score will be assessed between day 30, 6 months, and 12-18 months.
Measured: Day 30, 6 months, and 12-18 months
Ratio of packing density to number of coils used
This ratio indicates how many coils were needed to sufficiently pack the aneurysm. A higher ratio of packing density to number of coils used indicates that fewer coils were needed to sufficiently pack the aneurysm.
Measured: Treatment, day 1
Raymond-Roy occlusion classification (RROC)
Change in the post-coiling appearance of the aneurysm as measured by the Raymond-Roy occlusion classification (RROC) which is an angiographic classification scheme for grading the occlusion of endovascularly treated aneurysms.
class I: complete obliteration class II: residual neck class III: residual aneurysm
Measured: Post-procedure to 18 months
Change in Occlusion outcome status
Occlusion outcome status may be designated as stable, improved or worse.
Measured: baseline and 18 months
Aneurysm recurrence/coil compaction
Aneurysm recurrence/coil compaction is based on whether the coil has been able to stem blood flow. If coil compaction occurs, the aneurysm may recur. Response will be yes/no.
Measured: Post-procedure to 18 months
Rate of re-treatment or hemorrhage
Measured: at 6 months
Rate of re-treatment or hemorrhage
Measured: at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start2 Jun 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Kaneka Corporation
- Responsible party
- Principal investigator, Reade De Leacy, Icahn School of Medicine at Mount Sinai
- Investigators
- Reade De Leacy, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636124
- Sponsor's protocol ID
- STUDY-22-01480
- Acronym
- CLASS
- Status last verified
- Jun 2026
- First submitted
- 23 Nov 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Upon the completion of the study, Mount Sinai's data management team will clean and analysis all data in preparation of manuscript writing and publication. The intention will be to publish together between the principal investigator and the sponsor. Following publication, Mount Sinai will archive and store all associated data on its cloud-based system.
Publications
Gandhoke GS, Pandya YK, Jadhav AP, Jovin T, Friedlander RM, Smith KJ, Jankowitz BT. Cost of coils for intracranial aneurysms: clinical decision analysis for implementation of a capitation model. J Neurosurg. 2018 Jun;128(6):1792-1798. doi: 10.3171/2017.3.JNS163149. Epub 2017 Aug 25.
PubMed 28841115Bairstow P, Dodgson A, Linto J, Khangure M. Comparison of cost and outcome of endovascular and neurosurgical procedures in the treatment of ruptured intracranial aneurysms. Australas Radiol. 2002 Sep;46(3):249-51. doi: 10.1046/j.1440-1673.2002.01053.x.
PubMed 12196230Maeda JL, Raetzman SO, Friedman BS. What hospital inpatient services contributed the most to the 2001-2006 growth in the cost per case? Health Serv Res. 2012 Oct;47(5):1814-35. doi: 10.1111/j.1475-6773.2012.01460.x. Epub 2012 Sep 4.
PubMed 22946883
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effectiveness, Safety, and Efficacy of the Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT05636124
- Acronym / sponsor ID
- CLASS / STUDY-22-01480
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Kaneka Corporation
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 5 Dec 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.
This is a multi-center, prospective, propensity matched twin armed study conducted on 50 patients in the experimental arm followed for 18 months after intervention evaluating cost effectiveness, safety and efficacy of therapy.
Detailed description
Although coiling has become the most common form of treatment for intracranial aneurysms, there is evidence to suggest that the cost of coiling is on average 50% greater than the cost of clipping. Device costs represent the majority of this increased financial burden. This issue has only increased over time, as supplies and devices accounted for 24% of the increase in hospital costs per discharge from 2001 to 2006. The list price of coils on the US market ranges from $500 to $3000, thus small changes in the number of coils used per case can result in a large cost saving. The Kaneka iED coil is priced within this normal range, but offers a multi-diameter design that may reduce the number of coils required to achieve adequate embolization.
Aside from potential cost savings across all aneurysm types, the ability of the Kaneka iED to both frame and fill with a single coil may prove particularly effective in the treatment of wide-necked aneurysms. In these cases, a wide neck at the base of the aneurysm increased the risk for protrusion of the coil mass back into the normal lumen of the vessel, which can result in stroke and other severe complications. Adjunctive devices such as balloon and stents are often employed to reconstruct the aneurysm neck in these cases, and larger coil mass provided by the Kaneka iED may additionally serve to decrease the risk of coil protrusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kaneka i-ED coil | Experimental | Device: Kaneka i-ED coilPatients in the experimental arm will be treated according to the standard of care for endovascular aneurysm coiling, with no procedural modifications related to the use of the experimental device. |
| Matched patients who underwent intracranial aneurysm embolization | No intervention | –The comparator arm will be comprised of propensity matched patients who underwent intracranial aneurysm embolization as part of the FEAT Trial (NCT01655784). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neuroendovascular treating team
- Wide neck side wall or bifurcation intracranial aneurysms (neck > or = to 4 mm or dome-to-neck ratio < 2) within the anterior or posterior circulation
- The neurointerventionist feels that the aneurysm can be safely treated using endovascular techniques (direct or assisted coiling)
- Patients are 18-80 years of age (inclusive)
- Patient must be Hunt and Hess grade 0 to 3
Key exclusion criteria (5 listed)
- Patient has more than one aneurysm requiring treatment in the current treatment session, and only one of those to be treated aneurysms fits the Kaneka inclusion criteria (i.e., - if either (1) a patient has multiple aneurysms, but only one will be treated at enrollment; or (2) if two or more aneurysms are treated during the current treatment session and BOTH are able to be enrolled, then they remain eligible for the trial). Non-treated additional aneurysms may be treated at a later date with any coil type that the operator chooses).
- Target aneurysm has had previous coil treatment or has been surgically clipped
- Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage
- Inability to obtain informed consent
- Medical or surgical comorbidity such that the patient's life expectancy is less than 2 years
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 |
|---|---|---|
| Kaneka i-ED coilThe study device is the Kaneka i-ED coil T, FDA cleared under 510K number K192068. The coil is indicated for use in the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. | Device | Kaneka i-ED coil |
Primary outcome
Number of patients with Modified Raymond Roy 1-2 Occlusion classification without retreatment
Time frame: at 18 months
Modified Raymond Roy 1-2 occlusion at 18 months without retreatment. The Raymond-Roy Occlusion Classification has 3 responses, where Grade 1 is complete occlusion, no flow of contrast seen in the sac, Grade 2 is partial occlusion, some flow in the neck or sac, and Grade 3 is incomplete occlusion, apparent flow into the sac. Grade 1 indicates the best outcome.
Number of coils used
Time frame: up to 18 months post-treatment
Number of coils used to assess treatment-related cost effectiveness at treatment and over the course of follow-up to 18 months.
Packing density of coils
Time frame: up to 18 months post-treatment
Packing density of coils used to assess treatment-related cost effectiveness at treatment and over the course of follow-up to 18 months.
Number of device related serious adverse events
Time frame: up to 24 hours
Intra and peri-procedural (0-24 hours) device related serious adverse event rate.
Number of device related serious adverse events
Time frame: 24 hours to 30 days
Intra and peri-procedural (24 hours to 30 days) device related serious adverse event rate.
12 secondary outcomes
Rate of complete or near complete aneurysm occlusion without retreatment
Time frame: at 6 months
Number of patients with Modified Raymond-Roy classification 1
Time frame: at 18 months
Number of patients who suffer a Major ipsilateral stroke or neurological death
Time frame: at 6 months
Number of patients who suffer a Major ipsilateral stroke or neurological death
Time frame: at 18 months
Changes in Modified Rankin Scale (mRS) score
Time frame: Day 30, 6 months, and 12-18 months
Changes in National Institutes of Health Stroke Scale (NIHSS) score
Time frame: Day 30, 6 months, and 12-18 months
Ratio of packing density to number of coils used
Time frame: Treatment, day 1
Raymond-Roy occlusion classification (RROC)
Time frame: Post-procedure to 18 months
Change in Occlusion outcome status
Time frame: baseline and 18 months
Aneurysm recurrence/coil compaction
Time frame: Post-procedure to 18 months
Rate of re-treatment or hemorrhage
Time frame: at 6 months
Rate of re-treatment or hemorrhage
Time frame: at 18 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 12 Jun 2026.
- Background: PubMed 28841115Gandhoke GS, Pandya YK, Jadhav AP, Jovin T, Friedlander RM, Smith KJ, Jankowitz BT. Cost of coils for intracranial aneurysms: clinical decision analysis for implementation of a capitation model. J Neurosurg. 2018 Jun;128(6):1792-1798. doi: 10.3171/2017.3.JNS163149. Epub 2017 Aug 25.
- Background: PubMed 12196230Bairstow P, Dodgson A, Linto J, Khangure M. Comparison of cost and outcome of endovascular and neurosurgical procedures in the treatment of ruptured intracranial aneurysms. Australas Radiol. 2002 Sep;46(3):249-51. doi: 10.1046/j.1440-1673.2002.01053.x.
- Background: PubMed 22946883Maeda JL, Raetzman SO, Friedman BS. What hospital inpatient services contributed the most to the 2001-2006 growth in the cost per case? Health Serv Res. 2012 Oct;47(5):1814-35. doi: 10.1111/j.1475-6773.2012.01460.x. Epub 2012 Sep 4.
- Individual participant dataSharing planned: No. Upon the completion of the study, Mount Sinai's data management team will clean and analysis all data in preparation of manuscript writing and publication. The intention will be to publish together between the principal investigator and the sponsor. Following publication, Mount Sinai will archive and store all associated data on its cloud-based system.
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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.
Reade De Leacy principal investigator
Icahn School of Medicine at Mount Sinai
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kaneka i-ED coil in people with Intracranial Aneurysms and Wide Neck Intracranial Aneurysms, run by Icahn School of Medicine at Mount Sinai at 5 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 10 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Number of patients with Modified Raymond Roy 1-2 Occlusion classification without retreatment (time frame: at 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05636124, which also lists 3 linked publications.
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 12 Jun 2026.