Coiling for Brain Aneurysm

(STERLING Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of MICRUSFRAME and GALAXY coils, devices used to treat brain aneurysms, which are bulges in blood vessels in the brain. The study focuses on both ruptured and unruptured aneurysms. Participants should have a specific type of brain aneurysm called a saccular aneurysm, treatable with these coils. The trial seeks individuals with one aneurysm requiring treatment who are prepared to follow the study guidelines. As an unphased trial, this study provides an opportunity to contribute to medical knowledge and potentially benefit from innovative treatment options.

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 prior data suggests that these coils are safe for treating brain aneurysms?

Research has shown that the MICRUSFRAME and GALAXY coils are generally well-tolerated for treating brain aneurysms. In one study, these coils were successfully placed on the first try in over 95% of cases, indicating that the procedure usually proceeded smoothly. Additionally, the coils blocked at least 90% of the aneurysm in all five cases studied, demonstrating their effectiveness.

While specific safety data for these coils in humans is not detailed, they are part of an established treatment option, suggesting a good safety record. Since this trial is a post-market registry, the coils are already approved for use, indicating that regulatory bodies like the FDA have deemed them safe for humans. This approval is a positive sign regarding the treatment's safety for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MICRUSFRAME and GALAXY coils because they offer a new approach to treating brain aneurysms. Traditional methods often involve surgical clipping or older coil systems, which can be more invasive or less adaptable to complex aneurysm shapes. These new coils are designed to provide better stability and more effective packing of the aneurysm, potentially reducing the risk of rupture. Additionally, their advanced design aims to improve outcomes with less invasive procedures, making them a promising option for patients with challenging aneurysm cases.

What evidence suggests that MICRUSFRAME and GALAXY coils are effective for treating brain aneurysms?

Research has shown that MICRUSFRAME and GALAXY coils, which participants in this trial may receive, treat brain aneurysms—weak areas in blood vessels that can burst. These coils feature a special 3D design that helps them stay in place, particularly in aneurysms with wide openings. Studies indicate that this design reduces the risk of the aneurysm bursting again. The advanced technology in these coils marks a significant improvement in treating brain aneurysms. Although limited data from trials exist, their design and early use suggest effectiveness for many patients. ^{2 6 7 8 9}

Who Is on the Research Team?

Reade De Leacy, MD

Principal Investigator

Mount Sinai Hospital, New York

Osama Zaidat, MD

Principal Investigator

Mercy Health St. Vincent Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03642639

NCT03642639 | A Study to Look at Performance of ... A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms (STERLING). ClinicalTrials.gov ID NCT03642639.

2. withpower.com withpower.com/trial/phase-intracranial-aneurysm-7-2018-fdcae

Coiling for Brain Aneurysm (STERLING Trial) 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10126349/

A review of technological innovations leading to modern ... We review the major innovations within neurointervention that have led to the current state of brain aneurysm treatment.

4. clinconnect.io clinconnect.io/trials/NCT03642639?queryID=744827d4c4822e61c945&apos=57

A Study to Look at Performance of MICRUSFRAME and ... This clinical trial is studying the use of two types of coils, called MICRUSFRAME and GALAXY, to treat brain aneurysms. An aneurysm is a weak spot in a blood ...

5. umiamihealth.org umiamihealth.org/en/clinical-trials/a-study-to-look-at-performance-of-micrusframe-and-galaxy-coils-for-the-treatment-of-intracranial-ane

A Study to Look at Performance of MICRUSFRAME ... 1. Patient is between 21 and 80 years of age · 2. Patient has an intracranial saccular aneurysm, ruptured or unruptured, suitable for embolization with coils · 3.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/K033813.pdf

Micrus Corporation - accessdata.fda.gov Test data: Coils detached with the first detachment cycle in > 95% of detachments and ≥90% aneurysm occlusion was obtained in all 5 aneurysms.

7. jnjmedtech.com jnjmedtech.com/en-EMEA/product-family/spectra-aneurysm-coils

Spectra Family of Coils | CERENOVUS - J&J MedTech Find out about the Spectra family of coils that forms part of aneurysm treatment options from Cerenovus.

8. assets.ctfassets.net assets.ctfassets.net/ka7vsj9fzri4/2hxH2HYjiS2WV61dTGO5op/a2e302922884bbf6663ebd013d8e4a10/MCS-HES_SSCP_Final.pdf

Summary of Safety and Clinical Performance for MicroPlex ... The MicroPlex Coil System (MCS) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11129682/

Mid-term safety and efficacy in small intracranial aneurysm ... The primary objective is to evaluate the safety and effectiveness of Stryker second generation Target Nano Coils in the treatment of ruptured and unruptured ...