Surpass Evolve Flow Diverter for Brain Aneurysm

(EVOLVE Trial)

Recruiting at 40 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

248 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How is the Surpass Evolve Flow Diverter treatment different from other treatments for brain aneurysms?

The Surpass Evolve Flow Diverter is unique because it is a new generation device specifically designed to redirect blood flow away from brain aneurysms, promoting healing. It is particularly effective for treating small, distal cerebral artery aneurysms, offering a low-profile option that may be safer and more effective than other flow diverters. ^{1 2 3 4 5}

Research Team

Vitor M Pereira, MD

Principal Investigator

University Health Network, Toronto

Adam S Arthur, MD

Principal Investigator

Semmes Murphy Clinic

Eligibility Criteria

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.

I am between 18 and 80 years old.

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

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

First clinical experience with the new Surpass Evolve flow diverter: technical and clinical considerations. [2020]

2. Turkey pubmed.ncbi.nlm.nih.gov

The Evaluation of Low-Profile Surpass EvolveTM Flow Diverter for Endovascular Treatment of Distal Cerebral Artery Aneurysms: A Single-Center Experience. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Surpass Evolve Flow Diverter for the Treatment of Intracranial Aneurysm: A Systematic Review. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Early clinical experience of using the Surpass Evolve flow diverter in the treatment of intracranial aneurysms. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Initial Experience with Surpass Evolve Flow Diverter in the Treatment of Intracranial Aneurysms. [2021]