Kaneka Endovascular Embolization and Protection

Aneurysm Cerebral Clinical Trial

— KEEP  

Official title:

Kaneka Endovascular Embolization and Protection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05563051
• Other study ID #: KMA-IVRNV-001
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2022
• Est. completion date: October 2025

Study information

• Verified date: March 2024
• Source: Kaneka Medical America LLC
• Contact: Yuki Arimoto
• Phone: 3475253625
• Email: yuki.arimoto[@]kaneka.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm Cerebral

Intervention

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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Kaneka Medical America LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequate Occlusion	Proportion of subjects who achieve Adequate Occlusion (Modified Raymond-Roy I or II Classification)	12 months
Secondary	Complete Occlusion	Complete occlusion at 1 year (Modified Raymond-Roy I)	12 months
Secondary	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
Secondary	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
Secondary	Retreatment	Any retreatment of the aneurysm, surgically or interventional embolization	12 months
Secondary	Adverse events	Device or procedure related adverse events	12 months