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Coil System

Kaneka i-ED Coil for Brain Aneurysm (CLASS Trial)

N/A

Recruiting

Led By Reade De Leacy

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aneurysm 6-14 mm in diameter

The aneurysm has not been previously treated by coiling or clipping

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 18 months

Awards & highlights

CLASS Trial Summary

This trial studied if a medical therapy was safe, effective, and cost-effective over 18 months in 50 people.

Who is the study for?

This trial is for adults aged 18-80 with wide neck brain aneurysms that haven't been treated before. Candidates must be able to consent, or have a guardian who can, and agree to follow-up evaluations. They should be in relatively good health (Hunt and Hess grade 0-3) without conditions limiting life expectancy under two years.Check my eligibility

What is being tested?

The Kaneka i-ED coil system is being tested on patients with certain brain aneurysms to see if it's safe, effective, and cost-efficient. This study involves two groups of patients matched based on similar characteristics, with one group receiving the new treatment.See study design

What are the potential side effects?

While specific side effects are not listed here, endovascular treatments like coiling can generally include risks such as reaction to contrast dye, bleeding at the catheter site, or more rarely stroke-like symptoms due to vessel injury.

CLASS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My aneurysm is between 6 and 14 mm wide.

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My aneurysm has not been treated before.

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I am between 18 and 80 years old.

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My brain hemorrhage severity is mild to moderate.

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I have a brain aneurysm with a wide neck or it's at a branching point.

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My doctor says I need a special procedure for my brain aneurysm.

CLASS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of coils used

Number of device related serious adverse events

Number of patients with Modified Raymond Roy 1-2 Occlusion classification without retreatment

+1 more

Secondary outcome measures

Aneurysm recurrence/coil compaction

Change in Occlusion outcome status

Changes in Modified Rankin Scale (mRS) score

+7 more

CLASS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Kaneka i-ED coilExperimental Treatment1 Intervention

Patients in the experimental arm will be treated according to the standard of care for endovascular aneurysm coiling, with no procedural modifications related to the use of the experimental device.

Group II: Matched patients who underwent intracranial aneurysm embolizationActive Control1 Intervention

The comparator arm will be comprised of propensity matched patients who underwent intracranial aneurysm embolization as part of the FEAT Trial (NCT01655784).

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kaneka CorporationIndustry Sponsor

5 Previous Clinical Trials

199 Total Patients Enrolled

Icahn School of Medicine at Mount SinaiLead Sponsor

862 Previous Clinical Trials

525,583 Total Patients Enrolled

Reade De LeacyPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

1 Previous Clinical Trials

850 Total Patients Enrolled

Media Library

Kaneka iED Coil System (Coil System) Clinical Trial Eligibility Overview. Trial Name: NCT05636124 — N/A

Intracranial Aneurysms Research Study Groups: Matched patients who underwent intracranial aneurysm embolization, Kaneka i-ED coil

Intracranial Aneurysms Clinical Trial 2023: Kaneka iED Coil System Highlights & Side Effects. Trial Name: NCT05636124 — N/A

Kaneka iED Coil System (Coil System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05636124 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open to volunteers for this research?

"Per the information on clinicaltrials.gov, this medical study is not currently recruiting patients, though it was posted to the website on January 1st 2023 and last updated November 23rd 2022. Fortunately, there are 155 other studies in need of participants at present."

Answered by AI

Is enrollment for this trial limited to adults over 25 years old?

"This medical experiment necessitates that participants are between the ages of 18 and 80. For younger or senior patients, there is a pool 8 studies for those under 18 and 152 for applicants over 65 years old to consider."

Answered by AI

Who fulfills the qualifications for participation in this research?

"This investigation is searching for 50 subjects with intracranial aneurysm in the 18-80 year old demographic. To be accepted, individuals need to meet the following criteria: have a Hunt and Hess grade from 0 to 3, present with ruptured or unruptured cerebral aneurysms that are suitable for endovascular treatment as determined by a neuroendovascular team; wide neck sidewall or bifurcation intracranial aneurysms (neck ≥ 4 mm or dome-to-neck ratio < 2), within anterior/posterior circulation where it can safely treated using endovascular techniques"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms

Reade De Leacy 2023. "Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05636124.