Back to resultsKaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms (CLASS)
Primary Purpose
Intracranial Aneurysms, Wide Neck Intracranial Aneurysms
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kaneka i-ED coil
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Aneurysms
Eligibility Criteria
Inclusion criteria: 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. 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 Exclusion criteria: 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
Sites / Locations
- Sutter Health
- University of South FloridaRecruiting
- Icahn School of Medicine at Mount SinaiRecruiting
- Prisma HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Kaneka i-ED coil
Matched patients who underwent intracranial aneurysm embolization
Arm Description
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.
The comparator arm will be comprised of propensity matched patients who underwent intracranial aneurysm embolization as part of the FEAT Trial (NCT01655784).
Outcomes
Primary Outcome Measures
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.
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.
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.
Number of device related serious adverse events
Intra and peri-procedural (0-24 hours) device related serious adverse event rate.
Number of device related serious adverse events
Intra and peri-procedural (24 hours to 30 days) device related serious adverse event rate.
Secondary Outcome Measures
Rate of complete or near complete aneurysm occlusion without retreatment
Rate of complete or near complete aneurysm occlusion without retreatment 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.
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.
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.
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.
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.
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.
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
Change in Occlusion outcome status
Occlusion outcome status may be designated as stable, improved or worse.
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.
Rate of re-treatment or hemorrhage
Rate of re-treatment or hemorrhage
Full Information
NCT ID
NCT05636124
First Posted
November 23, 2022
Last Updated
October 3, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Kaneka Corporation
1. Study Identification
Unique Protocol Identification Number
NCT05636124
Brief Title
Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
Acronym
CLASS
Official Title
Cost Effectiveness, Safety, and Efficacy of the Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Kaneka Corporation
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
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysms, Wide Neck Intracranial Aneurysms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kaneka i-ED coil
Arm Type
Experimental
Arm Description
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.
Arm Title
Matched patients who underwent intracranial aneurysm embolization
Arm Type
No Intervention
Arm Description
The comparator arm will be comprised of propensity matched patients who underwent intracranial aneurysm embolization as part of the FEAT Trial (NCT01655784).
Intervention Type
Device
Intervention Name(s)
Kaneka i-ED coil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients with Modified Raymond Roy 1-2 Occlusion classification without retreatment
Description
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.
Time Frame
at 18 months
Title
Number of coils used
Description
Number of coils used to assess treatment-related cost effectiveness at treatment and over the course of follow-up to 18 months.
Time Frame
up to 18 months post-treatment
Title
Packing density of coils
Description
Packing density of coils used to assess treatment-related cost effectiveness at treatment and over the course of follow-up to 18 months.
Time Frame
up to 18 months post-treatment
Title
Number of device related serious adverse events
Description
Intra and peri-procedural (0-24 hours) device related serious adverse event rate.
Time Frame
up to 24 hours
Title
Number of device related serious adverse events
Description
Intra and peri-procedural (24 hours to 30 days) device related serious adverse event rate.
Time Frame
24 hours to 30 days
Secondary Outcome Measure Information:
Title
Rate of complete or near complete aneurysm occlusion without retreatment
Description
Rate of complete or near complete aneurysm occlusion without retreatment at 6 months
Time Frame
at 6 months
Title
Number of patients with Modified Raymond-Roy classification 1
Description
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.
Time Frame
at 18 months
Title
Number of patients who suffer a Major ipsilateral stroke or neurological death
Description
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.
Time Frame
at 6 months
Title
Number of patients who suffer a Major ipsilateral stroke or neurological death
Description
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.
Time Frame
at 18 months
Title
Changes in Modified Rankin Scale (mRS) score
Description
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.
Time Frame
Day 30, 6 months, and 12-18 months
Title
Changes in National Institutes of Health Stroke Scale (NIHSS) score
Description
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.
Time Frame
Day 30, 6 months, and 12-18 months
Title
Ratio of packing density to number of coils used
Description
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.
Time Frame
Treatment, day 1
Title
Raymond-Roy occlusion classification (RROC)
Description
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
Time Frame
Post-procedure to 18 months
Title
Change in Occlusion outcome status
Description
Occlusion outcome status may be designated as stable, improved or worse.
Time Frame
baseline and 18 months
Title
Aneurysm recurrence/coil compaction
Description
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.
Time Frame
Post-procedure to 18 months
Title
Rate of re-treatment or hemorrhage
Time Frame
at 6 months
Title
Rate of re-treatment or hemorrhage
Time Frame
at 18 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:
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.
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
Exclusion criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sydney Edwards
Phone
212 241 2524
Email
sydney.edwards@mountsinai.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sukaina Davdani
Phone
(212) 241-1497
Email
sukaina.davdani@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reade De Leacy
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sutter Health
City
Danville
State/Province
California
ZIP/Postal Code
94526
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamar Binyamin
First Name & Middle Initial & Last Name & Degree
Tamar Binyamin
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kunal Vakharia
First Name & Middle Initial & Last Name & Degree
Kunal Vakharia
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomoyoshi Shigematsu
First Name & Middle Initial & Last Name & Degree
Tomoyoshi Shigematsu
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan V Machaj
First Name & Middle Initial & Last Name & Degree
Jan V Machaj
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
28841115
Citation
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.
Results Reference
background
PubMed Identifier
12196230
Citation
Bairstow 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.
Results Reference
background
PubMed Identifier
22946883
Citation
Maeda 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.
Results Reference
background
Learn more about this trial
Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
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