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Embolization Device

Endovascular Coil Embolization for Brain Aneurysm (KEEP Trial)

N/A
Recruiting
Led By Ajit Puri, MD
Research Sponsored by Kaneka Medical America LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ruptured or unruptured
Target aneurysm of 4mm - 14mm in size
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

KEEP Trial Summary

This trial studies the safety & effectiveness of a medical device for heart valve repair. Up to 164 patients will be studied over up to 2 years.

Who is the study for?
This trial is for individuals with brain aneurysms measuring 4-14mm, which can be either ruptured or unruptured and are suitable for coil embolization. It's not open to those with worsening neurological conditions, planned staged procedures for the aneurysm, severe disability (mRS score ≥3), serious rupture symptoms (Hunt Hess Score >3), or signs of active infection.Check my eligibility
What is being tested?
The study is testing a device called i-ED COIL used in endovascular embolization to treat brain aneurysms. Participants will be monitored over one year at specific intervals after the procedure to assess outcomes and safety.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks of endovascular coil embolization include reaction to contrast dye, bleeding at the catheter site, blood vessel damage, stroke-like symptoms due to clotting or vessel blockage.

KEEP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition involves a rupture.
Select...
My aneurysm is between 4mm and 14mm in size.

KEEP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Adequate Occlusion
Secondary outcome measures
Adverse events
Complete Occlusion
Modified Rankin Score
+2 more

KEEP Trial Design

1Treatment groups
Experimental Treatment
Group I: Interventional treatmentExperimental Treatment1 Intervention
Open label

Find a Location

Who is running the clinical trial?

Kaneka Medical America LLCLead Sponsor
11 Previous Clinical Trials
540 Total Patients Enrolled
Ajit Puri, MDPrincipal InvestigatorUniversity of Massachusetts, Worcester
2 Previous Clinical Trials
288 Total Patients Enrolled
Mohamed Hussain, MDPrincipal InvestigatorThe Cleveland Clinic

Media Library

i-ED COIL (Embolization Device) Clinical Trial Eligibility Overview. Trial Name: NCT05563051 — N/A
Brain Aneurysm Research Study Groups: Interventional treatment
Brain Aneurysm Clinical Trial 2023: i-ED COIL Highlights & Side Effects. Trial Name: NCT05563051 — N/A
i-ED COIL (Embolization Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05563051 — N/A

Frequently Asked Questions

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

How widely distributed are the clinical trials of this study in America?

"McLaren Health Care in Grand Blanc, Michigan, Cleveland Clinic in Cleveland, Ohio and Northwell Health Lenox Hill Hospital in New york City are just a few of the medical centres hosting this clinical trial. There exists four other sites as well."

Answered by AI

Are new participants being admitted into this scientific experiment?

"Affirmative, the information on clinicaltrials.gov confirms that this research study is presently accepting volunteers for participation. This experiment was first posted on December 13th 2022 and has been recently updated as of March 17th 2023. It aims to recruit 164 people from 4 different medical centres."

Answered by AI

Does the study restrict enrollment to individuals aged 40 or over?

"This clinical trial requires applicants to be between 18 and 80. Those outside of this age range can consider the 7 trials for minors or the 166 studies designed specifically for individuals over 65 years old."

Answered by AI

To what extent is the research participant pool limited for this experiment?

"Verified. Clinicaltrials.gov data shows that this trial, initially posted on December 13th 2022, is actively searching for volunteers. A total of 164 participants are needed from 4 different sites."

Answered by AI

Is there still room for me to join this research endeavor?

"This clinical trial is accepting 164 people aged 18 to 80 with a brain aneurysm of between 4mm and 14mm, that can be embolized by coils. Furthermore, assistive devices are accepted for treatment - both ruptured or unruptured."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Kaneka Endovascular Embolization and Protection
2022. "Kaneka Endovascular Embolization and Protection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05563051.
~39 spots leftby Oct 2024
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