Reverse Medical Barrel™ Device for Adjunctive Treatment for Wide-Neck, Intracranial, Bifurcating/… (NCT02179190) | Clinical Trial Compass
CompletedNot Applicable
Reverse Medical Barrel™ Device for Adjunctive Treatment for Wide-Neck, Intracranial, Bifurcating/Branching Aneurysms
United States138 participantsStarted 2014-10-13
Plain-language summary
Single arm study to evaluate the outcomes of treatment with the Barrel VRD device as an adjunctive treatment to coiling for wide neck, intracranial, bifurcating/branching aneurysms in the middle cerebral and basilar arteries.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female between 18 and 85 years old.
. A wide-neck de novo or non-de novo aneurysm.
. Appropriate informed consent obtainable as determined by local IRB.
. Life expectancy \> 24 months.
Exclusion criteria
. Aneurysm rupture within 30 days of enrollment.
. Bifurcating aneurysms not treatable with coiling.
. Subject has platelet count of \<70,000.
. Subject has known allergies to nickel-titanium metal.
. Subject has known allergies to aspirin or heparin.
. Subject has a life-threatening allergy to contrast (unless treatment for allergy can be tolerated).
. Subject is currently participating in another clinical research study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period.
Timeframe: 12 months, after device implant
2
Number of Participants With Raymond Grade I ( 100%) Occlusion of the Aneurysms for Participants Treated With the Barrel VRD at 12 Months in the Absence of Retreatment, Parent Artery Stenosis, or Target Aneurysm Rupture