Phase 3
N=36
Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device
Intracranial Aneurysms
Bottom Line
View on ClinicalTrials.gov: NCT01541254 ↗Enrolled (actual)
36
Serious AEs
3.2%
Results posted
Sep 2014
Primary outcome: Primary: Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks) — 95 percent occlusion of aneurysm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Microvention-Terumo, Inc.
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks) |
95 | — |
| PRIMARY Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months |
— | — |
| SECONDARY Parent Artery Patency Measured Angiographically at 6 Months |
— | — |
| SECONDARY Successful Delivery of the LVIS™ Device Measures by Technical Success |
— | — |
| SECONDARY Significant Stenosis(>50%) of the Treated Artery at 6 Months |
— | — |
| SECONDARY Stent Migration at 6 Months |
— | — |
| SECONDARY Device and Procedure Related Serious Adverse Events |
— | — |
| SECONDARY Unplanned Embolization Coiling Within 6 Months |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subject whose age is between 18 and 80 years old
- Subject with unruptured wide neck, saccular,intracranial aneurysm, 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 participating in another clinical research study
- Subject who has had a previous intracranial stenting procedure associated with the target aneurysm
- Subject who is unable to complete the required follow-up
- Subject who is pregnant or breastfeeding
- Subject who has participated in a drug study within the last 30 days
Data sourced from ClinicalTrials.gov (NCT01541254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.