Kaneka Endovascular Embolization and Protection (KEEP)

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

Study Overview

• Status: Recruiting
• Conditions: Aneurysm Cerebral
• Intervention / Treatment: Device: i-ED COIL

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 Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuki Arimoto; Phone Number: 3475253625; Email: yuki.arimoto@kaneka.com
• Study Contact Backup: Name: Akihiro Dozono; Phone Number: 2127054365; Email: NV.Clinical@kaneka.com

Study Locations

• United States
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Recruiting
      • McLaren Health Care
  • New York
    • New York, New York, United States, 10075
      • Recruiting
      • Northwell Health Lenox Hill Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Recruiting
      • SSM Health St. Anthony's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Interventional treatment; Open label	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.; Other Names: Embolic coils; 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

Collaborators and Investigators

• Sponsor: Kaneka Medical America LLC
• Investigators: Principal Investigator: Ajit Puri, MD, University of Massachusetts, Worcester; Principal Investigator: Mohamed Hussain, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: aneurysm; embolization; coil; i-ED COIL; neuro endovascular
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID Numbers: KMA-IVRNV-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No