N/A
N=153
Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
Intracranial Aneurysms
Bottom Line
View on ClinicalTrials.gov: NCT01793792 ↗Enrolled (actual)
153
Serious AEs
31.4%
Results posted
Nov 2019
Primary outcome: Primary: Primary Effectiveness Composite Success "Number of Participants With Primary Effectiveness Composite Success (100% Aneurysm Occlusion Without Clinically Significant In-stent Stenosis or Target Aneurysm Retreatment" — 108 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LVIS™ and LVIS™ Jr (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Microvention-Terumo, Inc.
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Effectiveness Composite Success "Number of Participants With Primary Effectiveness Composite Success (100% Aneurysm Occlusion Without Clinically Significant In-stent Stenosis or Target Aneurysm Retreatment" |
108 | — |
| PRIMARY Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months |
9 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of the Low Profile Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.
Eligibility Criteria
Inclusion Criteria
- Subject age between 18 and 75 years
- Subject with an unruptured or ruptured(>30days since occurence), wide-necked (neck ≥4mm or dome to neck ratio 50%) proximal to the target aneurysm.
- Subject with any condition which in the opinion of the treating physician would place the subject at high risk of embolic stroke
- Subject with contraindications to the use of antiplatelet agents
- Subject who is unable to complete the required follow-up
Data sourced from ClinicalTrials.gov (NCT01793792). 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.