Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device (NCT01541254) | Clinical Trial Compass
CompletedPhase 2/3
Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device
United States30 participantsStarted 2012-03
Plain-language summary
The purpose of this study is to evaluate the safety and probable benefit of the Low-profile Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of unruptured wide-neck intracranial aneurysms with bare platinum embolization coils.
Who can participate
Age range
18 Years – 80 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:
* Subject whose age is between 18 and 80 years old
* Subject with unruptured wide neck, saccular,intracranial aneurysm, \< 20mm maximum diameter in any plane ( wide neck defined as neck width ≥ 4mm or dome to-neck ratio \< 2).
* Subject's aneurysm arises from a parent vessel with a diameter of ≥ 2.5m and ≤ 4.5mm.
* Subject or his/her legally authorized representative understands the nature of the procedure and provides signed informed consent form.
* Subject is willing to return to the investigational site for the 30- day and 6-month follow-up evaluations
Exclusion Criteria:
* Subject who presents with ruptured aneurysm, unless rupture occured 30 days or more prior to screening.
* Subject who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
* Subject with an International Normalized Ratio (INR)≥ 1.5
* Subject with serum creatinine level \>2mg/dl at time of enrollment
* Subject with known allergies to nickel-titanium metal
* Subject with known allergies to aspirin, heparin, ticlopidine, or clopidogrel
* Subject with a life threatening allergy to contrast(unless treatment for allergy is tolerated)
* Subject who has a known cardiac disorder, likely to be associated with cardioembolic symptoms such as atrial fibrillation
* Subject with any condition which in the opinion of the treating physician would place the subject at a high risk of embolic stroke
* Subject who is currently participat…
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
Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks)
Timeframe: 6 months ± 4 weeks
2
Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months