Surpass Evolve Flow Diverter for Brain Aneurysm

(EVOLVE Trial)

Not currently recruiting at 41 trial locations

Overseen By Alice Lin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stryker Neurovascular

Must be taking: Antiplatelet medications

Must not be taking: Chronic anticoagulation

Disqualifiers: Heart disease, Kidney failure, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: Procedure day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of the Surpass Evolve Flow Diverter System, a medical device designed to treat certain brain aneurysms. It targets unruptured, wide-neck aneurysms in specific areas of the brain's blood vessels. Individuals with a single unruptured brain aneurysm, particularly on the internal carotid artery or its branches, who meet other specific criteria, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to medical advancements in treating brain aneurysms.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but it mentions that you cannot participate if you have a medical contraindication to antiplatelet medications or are on chronic anticoagulation therapy. It's best to discuss your current medications with the trial team.

What prior data suggests that the Surpass Evolve Flow Diverter System is safe for treating brain aneurysms?

A previous study showed that the Surpass Evolve Flow Diverter System had a low rate of safety issues when treating brain aneurysms, suggesting it is generally well-tolerated. Another study found an acceptable rate of complications, indicating that serious side effects were uncommon. However, the safety and effectiveness of this device for treating small and medium wide-neck aneurysms remain unproven. While some uncertainty persists, early results are promising. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Surpass Evolve Flow Diverter System is unique because it offers a novel approach to treating brain aneurysms by redirecting blood flow away from the aneurysm, promoting healing. Unlike traditional options like surgical clipping or coiling, this system is minimally invasive and is delivered through a catheter, which can reduce recovery time and complications. Researchers are excited about it because the design optimizes blood flow redirection more efficiently and safely, potentially improving outcomes for patients with complex aneurysms.

What evidence suggests that the Surpass Evolve Flow Diverter System is effective for treating brain aneurysms?

Research has shown that the Surpass Evolve Flow Diverter System, which trial participants will receive, works well for treating brain aneurysms. One study found that 73% of these aneurysms were completely blocked about 10 months after treatment. Another study confirmed that the device is safe and effective, especially for complex aneurysms with wide necks in a major brain artery. The device has proven reliable with low safety risks in real-world use. Overall, the Surpass Evolve Flow Diverter System appears promising for managing unruptured brain aneurysms. ^{1 2 5 6 7}

Who Is on the Research Team?

Vitor M Pereira, MD

Principal Investigator

University Health Network, Toronto

Adam S Arthur, MD

Principal Investigator

Semmes Murphy Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with unruptured, wide-neck brain aneurysms ≤12 mm on the internal carotid artery or branches. Candidates should have a higher risk of rupture if untreated and no severe allergies to materials used in the procedure. Exclusions include recent major surgery, ongoing anticoagulation therapy, other serious medical conditions, pregnancy, or enrollment in another investigational product trial.

Inclusion Criteria

I have one unruptured brain aneurysm on the internal carotid artery or its branches.

Doctors believe treating my brain aneurysm with a procedure is safer than leaving it untreated.

My aneurysm is ≤ 12 mm, with specific neck and vessel size requirements.

Exclusion Criteria

I am allergic or cannot tolerate certain medications or anesthesia used in the study.

I have a bifurcation aneurysm.

My aneurysm is located in the back part of my brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Surpass Evolve Flow Diverter System for the treatment of unruptured, wide-neck intracranial aneurysms

Procedure day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including neurologic assessments and imaging

12 months (± 3 months)

Multiple visits (in-person)

Extended Follow-up

Long-term follow-up to evaluate secondary safety endpoints, including neurological death or major ipsilateral stroke

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Surpass Evolve Flow Diverter System

Trial Overview The Surpass Evolve Flow Diverter System is being tested for safety and effectiveness in treating small unruptured brain aneurysms. The device aims to divert blood flow away from the aneurysm to prevent rupture. Participants will be selected based on specific aneurysm characteristics and must not have had prior treatments that could interfere with this device.

How Is the Trial Designed?

Group I: Surpass Evolve Flow Diverter System Experimental Treatment 1 Intervention

This is a prospective single arm study in which all subjects who present for flow diverter implantation, provide informed consent, and meet inclusion/exclusion criteria may receive treatment (Surpass Evolve Flow Diverter).

Who Is Running the Clinical Trial?

Stryker Neurovascular

Lead Sponsor

Trials

36

Recruited

12,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10973831/

Safety and efficacy of Surpass Evolve Flow diverter for ... In this study, we found that aneurysm embolization using the Surpass Evolve FD is safe and efficacious in treating intracranial aneurysms. Occlusion rates, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38663997/

Safety and effectiveness assessment of the surpass evolve ... At median 10.2 [6.4-12.9] months follow-up, 233 (73.0%) aneurysms achieved complete occlusion. After adjusting for confounders, complete ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04195568

Evaluation of Safety and Effectiveness of Stryker Surpass ... The primary objective of this study is to evaluate the safety and effectiveness of the Surpass™ Evolve Flow Diverter System in the treatment of unruptured, ...

4. ejns.springeropen.com ejns.springeropen.com/articles/10.1186/s41984-024-00320-6

Surpass Evolve flow diverter in the treatment for complex wide ... This study shows that Surpass Evolve flow diverter is safe and validity for management of complex wide neck internal carotid artery aneurysm.

5. jnis.bmj.com jnis.bmj.com/content/15/Suppl_1/A248

a real-world international multicenter study Our results demonstrate that a 64-wire FD such as the SE has reliable effectiveness and carries a low rate of safety events in the treatment of mainly medium- ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0303846725001672

Efficacy and safety of surpass evolve flow diverters SE-FD is effective for treating intracranial aneurysms, with moderate efficacy compared to other devices and an acceptable rate of complications.

7. stryker.com stryker.com/content/dam/stryker/neurovascular/products/surpass-evolve-flow-diverter/downloads/US_Surpass%20Evolve%20DFU%20(1).pdf

Surpass Evolve™ Flow Diverter System The safety and effectiveness of the device has not been established in the treatment of small and medium wide-neck intracranial aneurysms. • Experience with ...