What side effects are associated with this type of intervention?

Flow diversion treatments for intracranial aneurysms, such as the Surpass™ Evolve Flow Diverter System, are generally associated with several side effects. Common adverse events include headaches, scalp pain, and neck pain. There is also a risk of more serious complications such as ischemic stroke and intracranial hemorrhage. Additionally, the use of antiplatelet therapy is often required, which can lead to bleeding complications. Despite these risks, flow diversion is considered a feasible treatment option with a relatively low-risk profile for managing unruptured, wide-neck intracranial aneurysms.

What prior FDA approvals exist?

The FDA has previously approved several flow diverter systems for the treatment of intracranial aneurysms. Notably, the Pipeline Embolization Device (PED) has been approved for redirecting blood flow away from the aneurysm, promoting thrombosis within the aneurysm, and reducing the risk of rupture. These devices are designed to treat unruptured, wide-neck intracranial aneurysms by providing a scaffold for endothelial growth, leading to the occlusion of the aneurysm over time. The Surpass™ Evolve Flow Diverter System is being studied for similar indications, aiming to offer a safe and effective treatment option for patients with intracranial aneurysms.

What other types of research exist?

Promising alternatives to the Surpass™ Evolve Flow Diverter System for treating intracranial aneurysms include the Pipeline™ Flex Embolization Device with Shield Technology, which offers enhanced flow diversion and reduced thrombogenicity, and the WEB™ Aneurysm Embolization System, which provides intrasaccular flow disruption and is particularly useful for wide-neck bifurcation aneurysms. Both devices have shown positive outcomes in recent studies and are gaining traction as effective treatments for intracranial aneurysms.

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Flow Diverter

Surpass Evolve Flow Diverter for Brain Aneurysm (EVOLVE Trial)

N/A

Waitlist Available

Led By Vitor M Pereira, MD

Research Sponsored by Stryker Neurovascular

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age is ≥ 18 and ≤ 80 years

Aneurysm characteristics: neck ≥ 4 mm, dome to neck ratio ≤ 2.0, or no discernible neck; size ≤ 12 mm (saccular or fusiform configuration); parent vessel diameter ≥ 1.75 mm and ≤ 5.0 mm at both proximal and distal segments

Must not have

Has a medical contraindication to study or procedure related medications or anesthesia

Has a true bifurcation aneurysm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 year follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device called the Surpass™ Evolve Flow Diverter System, which helps treat specific brain aneurysms in adults by redirecting blood flow to prevent them from bursting. The Surpass flow diverter is a new system under evaluation in the USA, designed to treat large and giant aneurysms.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions to materials in the device or medications used during the procedure, complications related to endovascular treatment such as bleeding or stroke-like symptoms due to changes in blood flow patterns around treated areas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a bifurcation aneurysm.

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

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I do not have any severe illnesses besides my neurological condition.

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I have an aneurysm outside my brain's protective covering.

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My blood vessels are not suitable for safe access to treat my aneurysm.

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I am on long-term blood thinners or have a bleeding disorder.

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I do not have an active infection.

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I haven't had major surgery in the last 30 days and don't plan any in the next 120 days.

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I've had treatments on the aneurysm or its main artery that could affect new device placement.

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A blood vessel connected to my aneurysm is causing concern.

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I have recent changes in my ability to move or feel.

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I am able to follow the study's requirements and do not have dementia, substance abuse issues, or a history of ignoring medical advice.

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I need treatment for more than one internal ailment within a year.

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I have a brain mass or untreated AVM near my aneurysm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 year follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 year follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 year follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Effectiveness Endpoint

Primary Safety Endpoint

Secondary study objectives

Secondary Safety Endpoints

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Surpass Evolve Flow Diverter SystemExperimental Treatment1 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).

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Flow diversion, as used in treatments like the Surpass™ Evolve Flow Diverter System, involves placing a stent-like device across the neck of an intracranial aneurysm. This device redirects blood flow away from the aneurysm sac, promoting thrombosis within the aneurysm and reducing the risk of rupture. This mechanism is crucial for patients as it stabilizes the aneurysm wall, preventing further blood flow into the aneurysm and significantly lowering the risk of severe neurological damage or death from a potential rupture.