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Embolization Device
Pipeline Embolization Device for Brain Aneurysm (ADVANCE Trial)
N/A
Waitlist Available
Led By Pascal Jabbour, MD
Research Sponsored by Medtronic Neurovascular Clinical Affairs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has a target intracranial aneurysm with an aneurysm neck ≥4mm or a dome-to-neck ratio of < 2
Age 22-80 years at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year, 2 year, and 3 year post-procedure
Awards & highlights
ADVANCE Trial Summary
This trial will test the safety and effectiveness of a new device to treat brain aneurysms.
Who is the study for?
This trial is for adults aged 22-80 with a wide-necked brain aneurysm in the internal carotid artery, who are selected for endovascular treatment and have multiple risk factors for rupture. They must not be pregnant, have had recent surgeries or other treatments that could interfere with the study, and should expect to live at least 3 more years.Check my eligibility
What is being tested?
The Pipeline™ Vantage Embolization Device with Shield Technology™ is being tested to see if it's safe and effective in treating brain aneurysms. The device will be used on participants' aneurysms within their intended use without additional devices like coils.See study design
What are the potential side effects?
Potential side effects may include reactions related to the implantation procedure such as bleeding or stroke, allergic reactions to device materials (platinum or cobalt chromium alloy), and complications from required antiplatelet therapy.
ADVANCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain aneurysm has a wide neck or is more bulbous than narrow.
Select...
I am between 22 and 80 years old.
Select...
My aneurysm is in the internal carotid artery.
Select...
I have a brain aneurysm with a specific size vessel near it.
Select...
I am chosen for a special procedure to treat my aneurysm.
ADVANCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year, 2 year, and 3 year post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year, 2 year, and 3 year post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety: Incidence of major stroke or neurological death
Secondary outcome measures
Effectiveness: Incidence of complete aneurysm occlusion
Effectiveness: Incidence of successful device implantation
Effectiveness: Incidence of target aneurysm recurrence
+3 moreADVANCE Trial Design
1Treatment groups
Experimental Treatment
Group I: Pipeline™ Vantage Embolization Device with Shield Technology™Experimental Treatment1 Intervention
Pipeline™ Vantage Embolization Device with Shield Technology™
Find a Location
Who is running the clinical trial?
Medtronic Neurovascular Clinical AffairsLead Sponsor
30 Previous Clinical Trials
8,667 Total Patients Enrolled
Pascal Jabbour, MDPrincipal InvestigatorThomas Jefferson University
Demetrius Lopes, MDPrincipal InvestigatorAdvocate Health
1 Previous Clinical Trials
250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood clotting test results are within the required range for the study.My brain aneurysm has a wide neck or is more bulbous than narrow.I am between 22 and 80 years old.You have had a metal device placed in your head near the aneurysm within the last 6 months.I have a small aneurysm (less than 12mm) that is not causing symptoms or growing, unless it's a specific type that can still be included even if it meets these criteria.You need to use extra devices during the procedure.I have had a stroke caused by a blood clot before.I have no health issues that prevent me from using the Pipeline™ device or taking blood-thinning medication.I have a bleeding disorder or am currently experiencing active bleeding.You are not able to have certain imaging tests during follow-up.I had surgery or a procedure involving blood vessels within the last 30 days.I had a brain hemorrhage or aneurysm rupture within the last 30 days.I have an aneurysm at the point where my internal carotid artery splits.You have an aneurysm with vessel features that make it risky for the device to fit properly and could increase the chance of complications.You are allergic to platinum or cobalt chromium alloy.My aneurysm is in the carotid artery but gets blood from the back of my brain.The fetal posterior communicating artery is found to be small, underdeveloped, or missing, and the blood flow is mainly supplied by the fetal posterior communicating artery to certain parts of the brain.My aneurysm is in the internal carotid artery.I have a condition like a severe blood vessel spasm, brain tumor, or abnormal blood vessel connection.I have a high risk of brain aneurysm rupture due to factors like smoking, high blood pressure, or family history.My aneurysm is located in the artery behind my brain.Criterion: The blood vessel branch comes from the top of the aneurysm.You are expected to live for at least 3 more years.I am pregnant or plan to become pregnant in the next year.You need to have a low level of disability before joining the study, which will be checked by a certified assessor at the study site.Criterion: The aneurysm and the medical device used for the procedure are too close to each other.I need treatment for another aneurysm in the same area during the study.I have a brain aneurysm with a specific size vessel near it.I am chosen for a special procedure to treat my aneurysm.
Research Study Groups:
This trial has the following groups:- Group 1: Pipeline™ Vantage Embolization Device with Shield Technology™
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.
Is this trial open to participants aged 45 and over?
"Qualified applicants for this medical trial must be aged between 22 to 80. Moreover, there are 7 trials tailored specifically for minors and 151 studies focusing on individuals older than 65 years old."
Answered by AI
What criteria must individuals meet in order to qualify for inclusion in this research project?
"This clinical trial is seeking 140 individuals aged between 22 and 80 with berry aneurysms who have a life expectancy of at least 3 years. Furthermore, the target intracranial aneurysm must be located in the internal carotid artery, they should already been selected for endovascular treatment, their P2Y12 reaction units (PRU) value needs to be between 60 and 200 or alternatively if tested via Thromboelastogram (TEG), a therapeutic ADP% between 30-90%. Lastly, subjects must show multiple increased risk factors for intracranialan eurysm rupture"
Answered by AI
Is this trial presently accepting new participants?
"The details on clinicaltrials.gov demonstrate that recruitment for this trial has ceased; it was first posted in April of 2020 and the last update occurred in August 2022. Nevertheless, there are still 153 other studies actively enrolling patients right now."
Answered by AI
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