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 range18 Years – 80 Years
SexALL
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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…
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