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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 year follow-up
Awards & highlights
EVOLVE Trial Summary
This trial will test if a new device is safe and effective in treating unruptured brain 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.Check my eligibility
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.See study design
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.
EVOLVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
Select...
My aneurysm is ≤ 12 mm, with specific neck and vessel size requirements.
Select...
I have one unruptured brain aneurysm on the internal carotid artery or its branches.
EVOLVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 year follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 year follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Effectiveness Endpoint
Primary Safety Endpoint
Secondary outcome measures
Secondary Safety Endpoints
EVOLVE 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).
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Who is running the clinical trial?
Stryker NeurovascularLead Sponsor
34 Previous Clinical Trials
11,990 Total Patients Enrolled
5 Trials studying Intracranial Aneurysms
968 Patients Enrolled for Intracranial Aneurysms
Vitor M Pereira, MDPrincipal InvestigatorUniversity Health Network, Toronto
Adam S Arthur, MDPrincipal InvestigatorSemmes Murphy Clinic
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Eligibility Criteria:
This trial includes the following eligibility 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.I do not have any severe illnesses besides my neurological condition.The aneurysm that needs to be treated is not suitable for flow diverter treatment.I have an aneurysm outside my brain's protective covering.I am on long-term blood thinners or have a bleeding disorder.I do not have an active infection.I had a brain bleed within the last 30 days.I haven't had major surgery in the last 30 days and don't plan any in the next 120 days.My blood vessels are not suitable for safe access to treat my aneurysm.I have one unruptured brain aneurysm on the internal carotid artery or its branches.I've had treatments on the aneurysm or its main artery that could affect new device placement.A blood vessel connected to my aneurysm is causing concern.You have another illness or condition that is expected to make your life shorter than 5 years.I am between 18 and 80 years old.Doctors believe treating my brain aneurysm with a procedure is safer than leaving it untreated.I have recent changes in my ability to move or feel.You had a brain implant in a specific area within the past 12 weeks.My aneurysm is ≤ 12 mm, with specific neck and vessel size requirements.I am able to follow the study's requirements and do not have dementia, substance abuse issues, or a history of ignoring medical advice.I have several risk factors for a brain aneurysm rupture.Your Modified Rankin Score (mRS) is 3 or higher before the procedure.I need treatment for more than one internal ailment within a year.I have a brain mass or untreated AVM near my aneurysm.
Research Study Groups:
This trial has the following groups:- Group 1: Surpass Evolve Flow Diverter System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum capacity for enrollees in this research endeavor?
"To move forward with this medical trial, 235 eligible participants are required. Those looking to partake can join at either the University of Utah in Salt Lake City or DIGNITY HEALTH/ Barrow Neurological Institute located in Phoenix, Arizona."
Answered by AI
Are patients currently being accepted into this experiment?
"Affirmative. Clinicaltrials.gov provides evidence that this research is recruiting participants; it was originally published on July 7th 2020 and updated recently on September 14th 2022. The trial requires 235 enrollees from 35 varied sites to be successful."
Answered by AI
Is inclusion in this trial confined to those aged 65 or below?
"To be qualified for participation in this clinical trial, prospective patients must be between 18 and 80 years old. Notably, there are 7 trials specifically targeting individuals younger than eighteen and 150 trials that target seniors above the age of 65."
Answered by AI
Is it possible to partake in this trial as a volunteer?
"Participation in this trial necessitates having intracranial aneurysm and being at least 18 years old, but no more than 80. It is forecasted to include approximately 235 participants."
Answered by AI
Are there various locations in this city where the research is being conducted?
"This trial has 38 active sites, including the University of Utah in Salt Lake City, DIGNITY HEALTH/ Barrow Neurological Institute in Phoenix and Thomas Jefferson University in Philadelphia."
Answered by AI
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