NCT05563051

Kaneka Endovascular Embolization and Protection

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Kaneka Medical America LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multi-center, non-randomized registry / study, up to 164 patients enrolled and followed at 180 days +/- 45 days and again at 365 days +/- 90 days post procedure

Detailed description

Assess and describe real world clinical data on i-ED coils Characterize the acute and long-term performance of iED coils when used for treating for an intracranial aneurysm May be used alone or in combination with other adjunctive device(s) Study Duration Anticipated timeline for study: Patient enrollment in 18 - 24 months Completion of follow-up 12 months after last patient enrolled

Conditions

• Aneurysm Cerebral

Interventions

Type	Name	Description
DEVICE	i-ED COIL	The i-ED COIL System (i-ED COIL and detachment box) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

Timeline

• Start date: 2022-12-13
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-10-03
• Last updated: 2025-10-07

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study