Clinical trial NCT05636124: Kaneka IED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
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
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Aneurysms
Wide Neck Intracranial Aneurysms
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Kaneka Corporation
First posted: 2022-12-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of patients with Modified Raymond Roy 1-2 Occlusion classification without retreatment
timeFrame: at 18 months
measure: Number of coils used
timeFrame: up to 18 months post-treatment
measure: Packing density of coils
timeFrame: up to 18 months post-treatment
measure: Number of device related serious adverse events
timeFrame: up to 24 hours
measure: Number of device related serious adverse events
timeFrame: 24 hours to 30 days
Secondary outcomes:
measure: Rate of complete or near complete aneurysm occlusion without retreatment
timeFrame: at 6 months
measure: Number of patients with Modified Raymond-Roy classification 1
timeFrame: at 18 months
measure: Number of patients who suffer a Major ipsilateral stroke or neurological death
timeFrame: at 6 months
measure: Number of patients who suffer a Major ipsilateral stroke or neurological death
timeFrame: at 18 months
measure: Changes in Modified Rankin Scale (mRS) score
timeFrame: Day 30, 6 months, and 12-18 months
measure: Changes in National Institutes of Health Stroke Scale (NIHSS) score
timeFrame: Day 30, 6 months, and 12-18 months
measure: Ratio of packing density to number of coils used
timeFrame: Treatment, day 1
measure: Raymond-Roy occlusion classification (RROC)
timeFrame: Post-procedure to 18 months
measure: Change in Occlusion outcome status
timeFrame: baseline and 18 months
measure: Aneurysm recurrence/coil compaction
timeFrame: Post-procedure to 18 months
measure: Rate of re-treatment or hemorrhage
timeFrame: at 6 months
measure: Rate of re-treatment or hemorrhage
timeFrame: at 18 months
Other outcomes:
Locations:
city: Danville
country: United States
facility: Sutter Health
state: California
city: Jacksonville
country: United States
facility: Baptist Health Jacksonville
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Reade De Leacy
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.