NCT05636124

Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms

Cost Effectiveness, Safety, and Efficacy of the Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Aneurysms
• Wide Neck Intracranial Aneurysms

Interventions

Type	Name	Description
DEVICE	Kaneka i-ED coil	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.

Timeline

• Start date: 2023-06-02
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2022-12-05
• Last updated: 2025-07-09

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study