Ignite Creation Date:
2024-05-06 @ 6:21 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05636124
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2022-11-23
Brief Title:
Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Cost Effectiveness Safety and Efficacy of the Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLASS
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None