Kaneka Endovascular Embolization and Protection

Not Applicable

Recruiting

• Conditions: Aneurysm Cerebral
• Interventions: Device: i-ED COIL

• Registration Number: NCT05563051
• Lead Sponsor: Kaneka Medical America LLC

Brief 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

Study Timeline

• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-10-03
• Study Start: 2022-12-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• Target aneurysm of 4mm - 14mm in size
• Ruptured or unruptured
• Suitable for embolization with coils
• May be treated with or without assist devices

Exclusion Criteria

• Unstable neurological deficit in unruptured cases (condition worsening within last 90 days)
• Pre-planned staged procedure of target aneurysm
• mRS score 3 or more
• Hunt Hess Score more than 3 for subjects with ruptured aneurysm
• Evidence of active infection (e.g.,fever, temperature >38 degrees C and/or WBC >15,000)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional treatment	i-ED COIL	Open label

Primary Outcome Measures

Name	Time	Method
Adequate Occlusion	12 months	Proportion of subjects who achieve Adequate Occlusion (Modified Raymond-Roy I or II Classification)

Secondary Outcome Measures

Name	Time	Method
Complete Occlusion	12 months	Complete occlusion at 1 year (Modified Raymond-Roy I)
Adverse events	12 months	Device or procedure related adverse events
Packing Density	12 months	Aneurysm volume and percent of aneurysm packing for coil embolization. Packing density will be evaluated based on aneurysm volume and coil volume
Modified Rankin Score	12 months	Modified Rankin Score (Scale from 0-6), the lower the score the better - 0 No symptoms and 6 is dead.; 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. Dead
Retreatment	12 months	Any retreatment of the aneurysm, surgically or interventional embolization

Trial Locations

Locations (4)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

McLaren Health Care; 🇺🇸 Grand Blanc, Michigan, United States

Northwell Health Lenox Hill Hospital; 🇺🇸 New York, New York, United States

SSM Health St. Anthony's Hospital; 🇺🇸 Oklahoma City, Oklahoma, United States