Kaneka Endovascular Embolization and Protection | NCT05563051

Studies
Kaneka Endovascular Embolization and Protection

NCT05563051

Sponsor

Kaneka Medical America LLC

Status

Active, not recruiting

Last Update Posted

Oct 7, 2025Actual

Enrollment

164Estimated

Phase

Not Applicable

Conditions

Aneurysm Cerebral

Interventions

i-ED COIL

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 13, 2022Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Sep 28, 2022

First Submission Date that Met QC Criteria

Sep 28, 2022

First Posted Date

Oct 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2025

Last Update Posted Date

Oct 7, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

164Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interventional treatment	Other	Open label	Device: i-ED COIL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
i-ED COIL	Device	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ajit Puri, MD	University of Massachusetts, Worcester	Principal Investigator
Mohamed Hussain, MD	The Cleveland Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McLaren Health Care		Grand Blanc	Michigan	48439	United States
Northwell Health Lenox Hill Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002532	Intracranial Aneurysm
D000783	Aneurysm

Ancestor Terms

ID	Term
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided