Surpass Evolve Flow Diverter for Brain Aneurysm
(EVOLVE Trial)

Recruiting in Palo Alto (17 mi)

+40 other locations

Overseen byAdam S Arthur, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Stryker Neurovascular

No Placebo Group

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.

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.

See 2 more

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.

See 21 more

Treatment Details

Interventions

Surpass Evolve Flow Diverter System (Flow Diverter)

Trial OverviewThe 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

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).