Endovascular Coil Embolization for Brain Aneurysm

(KEEP Trial)

Not currently recruiting at 3 trial locations

Overseen By Akihiro Dozono

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaneka Medical America LLC

Disqualifiers: Unstable neurological deficit, mRS score 3+, Hunt Hess score 3+, active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 18-24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called i-ED COIL, an endovascular device, to manage brain aneurysms, which are bulges in brain blood vessels. The goal is to evaluate the effectiveness of this treatment for aneurysms between 4mm and 14mm in size, regardless of whether they have burst. Suitable candidates for this trial have a brain aneurysm treatable with coils and have not experienced worsening neurological conditions in the past 90 days. Researchers will follow participants for up to a year to monitor their progress. As an unphased trial, this study allows patients to contribute to innovative research that could enhance aneurysm management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What prior data suggests that the i-ED COIL System is safe for endovascular coil embolization?

A previous study found that treating brain aneurysms with endovascular coil embolization was generally safe. Serious complications occurred rarely. Specifically, only about 14.3% of patients treated with the i-ED coils experienced a minor issue called an "internal remnant," where a small part of the aneurysm wasn't completely treated. However, this is not a major concern for most patients. Overall, the treatment is well-tolerated, with low rates of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for brain aneurysms, which often involve surgical clipping or conventional coil embolization, the i-ED COIL is unique because it uses advanced endovascular technology to deliver coils directly into the aneurysm. This technique allows for a minimally invasive approach, reducing the need for open surgery and potentially decreasing recovery time. Researchers are excited about the i-ED COIL because its design may provide better aneurysm stability and less risk of recurrence compared to standard coils, offering a promising new option for patients.

What evidence suggests that the i-ED COIL is effective for brain aneurysm?

Research shows that the i-ED COIL, which participants in this trial will receive, is designed to block blood flow in brain aneurysms. Early findings suggest these coils can work with aneurysms of different sizes and shapes. In past studies, patients using these coils experienced positive outcomes, making the i-ED COIL a promising option. These coils have proven practical and effective for treating aneurysms. The treatment uses a flexible design, which helps fit the coil into the aneurysm safely. Overall, these results suggest that the i-ED COIL is a reliable choice for managing brain aneurysms. ^{3 4 5 6 7}

Who Is on the Research Team?

Ajit Puri, MD

Principal Investigator

University of Massachusetts, Worcester

Mohamed Hussain, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My condition involves a rupture.

My aneurysm is between 4mm and 14mm in size.

I can use assistive devices if needed.

Exclusion Criteria

My neurological condition has worsened in the last 90 days.

I am scheduled for a step-by-step surgery on my aneurysm.

My Hunt Hess Score is over 3 due to a ruptured aneurysm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive i-ED coils for treating intracranial aneurysm, which may be used alone or with adjunctive devices

18-24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 180 days and 365 days post-procedure

12 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• i-ED COIL

Trial Overview 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.

How Is the Trial Designed?

Group I: Interventional treatment Experimental Treatment 1 Intervention

Open label

i-ED COIL is already approved in United States, Japan for the following indications:

Approved in United States as i-ED COIL System for:

• Endovascular embolization of intracranial aneurysms
• Neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• Vascular occlusion of blood vessels within the neurovascular system
• Arterial and venous embolizations in the peripheral vasculature

Approved in Japan as i-ED COIL System for:

• Endovascular embolization of intracranial aneurysms
• Neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae

Who Is Running the Clinical Trial?

Kaneka Medical America LLC

Lead Sponsor

Trials

13

Recruited

720+

Published Research Related to This Trial

In a study of 145 patients with 153 aneurysms treated using hydrogel-coated coils, the effectiveness of the treatment improved significantly over time, with 90% of aneurysms showing good occlusion at the 5-year follow-up.

The retreatment rate was 14% over five years, and importantly, there were no recorded rerupture events, indicating a strong safety profile for this method of aneurysm treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Follow-up of Aneurysms Treated With Hydrogel-Coated Coils Shows Progressive Thrombosis and Improvement in Raymond-Roy Classification. Nickele, C., Oravec, CS., Morris, SD., et al.[2022]

Endovascular coil embolization is a widely accepted first-line treatment for both ruptured and unruptured intracranial aneurysms, highlighting its efficacy in managing these conditions.

The review emphasizes the importance of understanding technical complications related to coil deployment and the available salvage techniques, which are crucial for improving patient safety during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular coils: properties, technical complications and salvage techniques. Eddleman, CS., Welch, BG., Vance, AZ., et al.[2016]

In a study of 36 patients treated with the Pipeline Embolization Device (PED) for intracranial aneurysms, the procedure was successful in all cases, achieving stasis in all treated aneurysms, indicating its efficacy in managing these conditions.

However, the study also reported a 13.9% rate of symptomatic postoperative complications, including serious issues like intracerebral hemorrhage and stroke, highlighting the need for careful patient selection and consideration of risks associated with the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single center experience with pipeline stent: feasibility, technique, and complications. Chitale, R., Gonzalez, LF., Randazzo, C., et al.[2012]

Thromboembolic events are the most significant adverse effect associated with coil embolization for treating intracerebral aneurysms.

The study aimed to identify risk factors for these thromboembolic events by using diffusion-weighted imaging (DWI) to compare both unruptured and ruptured aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thromboembolic Events during Endovascular Coil Embolization of Cerebral Aneurysms. Ishibashi, T., Murayama, Y., Saguchi, T., et al.[2021]

Coil embolization of very small intracranial aneurysms (≤3 mm) is effective, achieving complete occlusion in 85% of cases postoperatively and 91% at long-term follow-up, based on a systematic review of 22 studies involving 1105 aneurysms.

While the procedure is generally safe, with a low recanalization rate of 6% and good long-term neurologic outcomes in 79% of patients, there are notable risks, including a 7% rate of intraprocedural rupture and 4% of thromboembolic complications, which should be considered in treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular Treatment of Very Small Intracranial Aneurysms: Meta-Analysis. Yamaki, VN., Brinjikji, W., Murad, MH., et al.[2021]

In a study of 92 cerebral aneurysms treated with the ED coil-10 Extra Soft (EDC-10 ES), 68.5% achieved complete occlusion immediately after embolization, which improved to 78.3% at the 6-month follow-up, demonstrating the coil's efficacy.

The procedure had a low complication rate of 3.3%, and the overall recurrence rate of aneurysms was 10.0%, indicating that the EDC-10 ES is a safe option for embolization with effective long-term results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with an extremely soft bare platinum coil, ED coil-10 Extra Soft, for endovascular treatment of cerebral aneurysms. Harada, K., Morioka, J.[2022]

In a study of 30 patients who underwent endovascular coil embolization for cerebral aneurysms, 23% exhibited new CT-detectable hyperdensities, which were asymptomatic and resolved within 25 hours, indicating a benign nature of these findings.

The presence of hyperattenuation on CT scans was statistically linked to the amount of contrast used and the continuation of antiplatelet medication, suggesting that these factors may influence the incidence of contrast enhancement after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast enhancement hyperdensity after endovascular coiling of intracranial aneurysms. Brisman, JL., Jilani, M., McKinney, JS.[2021]

The DELTA trial is a large-scale study involving 564 patients aimed at determining whether using larger 15-caliber coils for embolization of cerebral aneurysms leads to better occlusion rates compared to standard 10-caliber coils.

The primary goal is to assess the occurrence of major recurrences or residual aneurysms after one year, which will help establish the efficacy and safety of using larger coils in preventing aneurysm rebleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular treatment of aneurysms and platinum coil caliber: Study protocol of a randomized, controlled trial. Ghostine, J., Khoury, N., Cloutier, F., et al.[2022]

In a study of 42 patients with 45 intracranial aneurysms, a new endovascular coil placement technique successfully preserved blood flow through incorporated arteries (IAs) without occlusion, demonstrating its safety and efficacy.

Despite some cases of aneurysmal regrowth, all patients followed for an average of 21 months showed no re-bleeding, indicating that this technique is a viable alternative for treating selected aneurysms with IAs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A coil placement technique to treat intracranial aneurysm with incorporated artery. Luo, CB., Chang, FC., Lin, CJ., et al.[2019]

In a study involving 112 patients with 116 cerebral aneurysms, the TRUFILL DCS Detachable Coil System achieved a mean aneurysm occlusion rate of 93.5%, with 90.2% of aneurysms showing at least 90% occlusion, indicating high efficacy in treating both ruptured and unruptured aneurysms.

The complication rates were relatively low, with 6.9% device-related and 2.6% procedure-related complications, and only two serious adverse events, demonstrating the safety of the TRUFILL DCS coil system in clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Clinical Experience with a New Complex-Shaped Detachable Platinum Coil System for the Treatment of Intracranial Cerebral Aneurysms. The Cordis Trufill DCS Detachable Coil System. Higashida, RT., Cognard, C., Bracard, S.[2021]

Symptomatic inflammatory reactions can occur after coil embolization of cerebral aneurysms, even with nonbioactive coils, as demonstrated by a case of perianeurysmal edema following treatment of a small unruptured aneurysm with bare platinum coils.

This highlights the need for careful monitoring of patients after coil embolization, as adverse events can arise not only from bioactive coils but also from traditional nonbioactive options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptomatic perianeurysmal edema following bare platinum embolization of a small unruptured cerebral aneurysm. Craven, I., Patel, UJ., Gibson, A., et al.[2021]

The endovascular coiling procedure for treating intracranial aneurysms demonstrated a high technical success rate of 95.3% across 43 patients, indicating its effectiveness as a treatment option.

The procedure resulted in a good clinical outcome for 78% of patients, with a low mortality rate of 2.3%, suggesting that it is a safe intervention for managing both ruptured and un-ruptured aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of intracranial aneurysms using detachable coils; initial results at a university hospital in Pakistan. Hamid, RS., Tanveer-ul-Haq, ., Chishti, I., et al.[2019]

Citations

1. withpower.com withpower.com/trial/endovascular-coil-embolization-for-brain-aneurysm-648e2

Endovascular Coil Embolization for Brain Aneurysm · Info ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05636124

Kaneka iED Coil System for the Treatment of Wide Necked ... This is a multi-center, prospective, propensity matched twin armed study conducted on 50 patients in the experimental arm followed for 18 months after ...

3. kanekanv.com kanekanv.com/

Kaneka Neuro USA - Kaneka The i-ED Coil® System, featuring the i-ED COIL and EDG v4, is designed for the endovascular embolization of critical neurovascular conditions. This advanced ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37151447/

Low-memory shape coils for intracranial aneurysm coiling Our initial experience with i-ED coils has shown that they are a feasible strategy in a number of differently sized and shaped aneurysms.

5. surgicalneurologyint.com surgicalneurologyint.com/surgicalint-articles/low-memory-shape-coils-for-intracranial-aneurysm-coiling-initial-and-single-center-experience-with-the-i-ed-coil/

Low-memory shape coils for intracranial aneurysm coiling Our initial experience with i-ED coils has shown that they are a feasible strategy in a number of differently sized and shaped aneurysms.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K192068.pdf

April 25, 2020 Kaneka Pharma America LLC Takeaki Miyata ... The i-ED COIL System (i-ED COIL and EDG v4) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular ...

7. kanekanv.com kanekanv.com/i-ed-coil-systems

i-ED Coil System - Kaneka The i-ED COIL System (i-ED COIL and EDG v4) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities ...