Endovascular Coil Embolization for Brain Aneurysm

(KEEP Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Ajit Puri, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Kaneka Medical America LLC

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

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment i-ED COIL, i-ED COIL System, i-ED COIL and EDG v4 for brain aneurysms?

Research shows that endovascular coil embolization is a well-established and often first-choice treatment for brain aneurysms, with studies indicating promising results, especially for very small aneurysms. This suggests that the i-ED COIL and related systems could be effective in treating brain aneurysms. ^{1 2 3 4 5}

Is endovascular coil embolization for brain aneurysms generally safe?

Endovascular coil embolization for brain aneurysms is generally considered safe, with studies showing low rates of serious complications. Some patients may experience inflammatory reactions or thromboembolic events (blood clots), but these are relatively rare. ^{6 7 8 9 10}

How is the i-ED COIL treatment for brain aneurysms different from other treatments?

The i-ED COIL treatment is unique because it involves an extremely soft coil that offers excellent operability for embolization (blocking blood flow) of cerebral aneurysms, often used as a 'finishing coil' to ensure better aneurysm occlusion and reduce the risk of recurrence. ^{2 4 9 11 12}

Research Team

Ajit Puri, MD

Principal Investigator

University of Massachusetts, Worcester

Mohamed Hussain, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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 am a candidate for a procedure using coils to block blood flow.

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.

Trial Timeline

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)

Treatment Details

Interventions

• i-ED COIL (Embolization Device)

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.

Participant Groups

Group I: Interventional treatment Experimental Treatment 1 Intervention

Open label

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

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. Pakistan pubmed.ncbi.nlm.nih.gov

Treatment of intracranial aneurysms using detachable coils; initial results at a university hospital in Pakistan. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Contrast enhancement hyperdensity after endovascular coiling of intracranial aneurysms. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Endovascular Treatment of Very Small Intracranial Aneurysms: Meta-Analysis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Single center experience with pipeline stent: feasibility, technique, and complications. [2012]

5. England pubmed.ncbi.nlm.nih.gov

Endovascular coils: properties, technical complications and salvage techniques. [2016]

6. United States 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Thromboembolic Events during Endovascular Coil Embolization of Cerebral Aneurysms. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Symptomatic perianeurysmal edema following bare platinum embolization of a small unruptured cerebral aneurysm. [2021]

9. England 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. [2022]

10. United States 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. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Endovascular treatment of aneurysms and platinum coil caliber: Study protocol of a randomized, controlled trial. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

A coil placement technique to treat intracranial aneurysm with incorporated artery. [2019]