Coiling for Brain Aneurysm

(STERLING Trial)

Recruiting at 2 trial locations

Overseen By Lillian Ma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.

Disqualifiers: Staged procedure, Multiple aneurysms, Fusiform aneurysm

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 12 months

850 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment MICRUSFRAME and GALAXY coils for brain aneurysms?

Research shows that Micrus 3D microcoils are stable and effective in treating wide-necked aneurysms, with minimal complications in most cases. Additionally, the Galaxy XTRASOFT coils have been found to be safe and effective, achieving high rates of aneurysm closure with a low complication rate. ^{1 2 3 4 5}

Is coiling for brain aneurysms generally safe for humans?

Research shows that coiling for brain aneurysms, including using Micrus and Cerecyte coils, is generally safe, with most patients experiencing no complications. However, there can be risks, such as aneurysm bleeding during the procedure, but these are often controlled. Overall, the safety of these coils has been proven in various studies. ^{1 2 3 6 7}

How is the coiling treatment with MICRUSFRAME and GALAXY coils unique for brain aneurysms?

The MICRUSFRAME and GALAXY coils are unique because they use a 3D microcoil design that provides stable protection for wide-necked aneurysms by keeping the coil mesh inside the aneurysm, reducing technical failures and complications compared to other coiling methods. ^{1 8 9 10 11}

What is the purpose of this trial?

A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils

Research Team

Reade De Leacy, MD

Principal Investigator

Mount Sinai Hospital, New York

Osama Zaidat, MD

Principal Investigator

Mercy Health St. Vincent Hospital

Eligibility Criteria

This trial is for adults aged 21-80 with a brain aneurysm (a bulge in a blood vessel in the brain) that can be treated with coils. Participants must be able to follow the study's procedures and visits.

Inclusion Criteria

I am between 21 and 80 years old.

I have a brain aneurysm that can be treated with coiling.

I am able and willing to follow the study's requirements.

Exclusion Criteria

I am scheduled for a procedure on an unruptured aneurysm.

I have a spindle-shaped bulge in my blood vessel.

I need treatment for more than one aneurysm.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive endovascular treatment of intracranial aneurysms using MICRUSFRAME and GALAXY coils

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including occlusion and recanalization rates

12 months

Treatment Details

Interventions

• MICRUSFRAME and GALAXY coils

Trial Overview The performance of two types of coils, MICRUSFRAME and GALAXY, is being evaluated for treating both ruptured and unruptured intracranial saccular aneurysms.

Participant Groups

Group I: Coils Experimental Treatment 1 Intervention

MICRUSFRAME and GALAXY coils

Who Is Running the Clinical Trial?

Cerenovus, Part of DePuy Synthes Products, Inc.

Lead Sponsor

Trials

10

Recruited

5,600+

References

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

3D Micrus Coil "Cage" in Wide-Necked Aneurysms. [2021]

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

Cerecyte coil trial: angiographic outcomes of a prospective randomized trial comparing endovascular coiling of cerebral aneurysms with either cerecyte or bare platinum coils. [2022]

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

Initial experience with bioactive cerecyte detachable coils: impact on reducing recurrence rates. [2014]

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

The Orbit Galaxy XTRASOFT Coils: A Multicenter Study of Coil Safety and Efficacy in Both Ruptured and Unruptured Cerebral Aneurysms. [2021]

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

International Subarachnoid Aneurysm Trial - ISAT part II: study protocol for a randomized controlled trial. [2021]

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

Procedural complications of coiling of ruptured intracranial aneurysms: incidence and risk factors in a consecutive series of 681 patients. [2022]

7. France pubmed.ncbi.nlm.nih.gov

Selective endovascular treatment of intracranial aneurysms using micrus microcoils: preliminary results in a series of 78 patients. [2019]

8. Poland pubmed.ncbi.nlm.nih.gov

[Embolitic material (coils) dislocation inside a giant and cerebral aneurysm and morphological aneurysm changes after coiling. Case report]. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Stiff coils enhance shape retention and pressure resistance in an aneurysm model even at low volume. [2022]

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

Precision microcatheter shaping in vertebrobasilar aneurysm coiling. [2020]

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

Intracranial aneurysms coiling with matrix: immediate results in 152 patients and midterm anatomic follow-up from 115 patients. [2019]