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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Sutter Health
Danville, California, United States
Baptist Health Jacksonville
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours to 30 days
Rate of complete or near complete aneurysm occlusion without retreatment
Rate of complete or near complete aneurysm occlusion without retreatment at 6 months
Time frame: at 6 months
Number of patients with Modified Raymond-Roy classification 1
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Prisma Health
Greenville, South Carolina, United States
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Post-procedure to 18 months
Change in Occlusion outcome status
Occlusion outcome status may be designated as stable, improved or worse.
Time frame: 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.
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