Kaneka Endovascular Embolization and Protection

Study Overview
=================
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

Official Title
-----------------
Kaneka Endovascular Embolization and Protection

Conditions
-----------------
Aneurysm Cerebral

Intervention / Treatment
-----------------
* Device: i-ED COIL


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Interventional treatment<br>Open label | Device: i-ED COIL<br>* 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.<br>* Other names: Embolization coils;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate Occlusion | Proportion of subjects who achieve Adequate Occlusion (Modified Raymond-Roy I or II Classification) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Occlusion | Complete occlusion at 1 year (Modified Raymond-Roy I) | 12 months | 
| Packing Density | Aneurysm volume and percent of aneurysm packing for coil embolization. Packing density will be evaluated based on aneurysm volume and coil volume | 12 months | 
| Modified Rankin Score | Modified Rankin Score (Scale from 0-6), the lower the score the better - 0 No symptoms and 6 is dead. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead | 12 months | 
| Retreatment | Any retreatment of the aneurysm, surgically or interventional embolization | 12 months | 
| Adverse events | Device or procedure related adverse events | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aneurysm, coil, i-ED COIL, embolization, neuro endovascular