Journal article
Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device
Journal of neurointerventional surgery, Vol.8(9), pp.894-897
09/2016
DOI: 10.1136/neurintsurg-2015-011937
PMID: 26391016
Abstract
IntroductionThe low-profile visualized intraluminal support (LVIS) device is a new, braided, intracranial microstent designed for stent-assisted coiling.ObjectiveTo present the results of a single-arm, prospective, multicenter trial of the LVIS for treatment of wide-necked intracranial aneurysms.Methods31 patients with unruptured, wide-necked (neck ≥4 mm or dome:neck ratio ≤2) intracranial aneurysms were treated with the LVIS device and bare platinum coils at six US centers (investigational device exemption G110014). Clinical follow-up was conducted at 30 days and 6 months. Angiographic follow-up was performed at 6 months. The primary safety endpoint was any major stroke or death within 30 days or major ipsilateral stroke or neurological death within 6 months. ‘Probable benefit’ was defined as ≥90% angiographic occlusion at 6 months. An independent core laboratory adjudicated the angiographic results. An independent clinical events committee adjudicated the clinical endpoints.ResultsAverage aneurysm size was 7.2 mm (SD 3.8) and average neck width was 4.6 mm (SD 1.8). 68% of patients had a dome:neck ratio ≤2. LVIS placement was technically successful in 29/31 patients (93.5%). No primary safety endpoints occurred during the study (0%). No patient had a higher modified Rankin Score at 6 months than at baseline. 26/28 (92.9%) treated aneurysms with 6-month angiographic follow-up demonstrated ≥90% angiographic occlusion. 21/28 (75%) were completely occluded at follow-up.ConclusionsThe LVIS device facilitated the coil embolization of wide-necked intracranial aneurysms with high rates of technical success, an excellent safety profile, and very high rates of complete and near-complete occlusion at follow-up.Trial registration numberNCT01541254.
Details
- Title: Subtitle
- Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device
- Creators
- David Fiorella - Department of Neurosurgery, State University of New York at Stony Brook, Stony Brook, New York, USAAdam Arthur - Methodist Hospital, Memphis, Tennessee, USAAlan Boulos - Albany Medical Center, Albany, New York, USAOrlando Diaz - Methodist Houston, Houston, Texas, USAPascal Jabbour - Department of Neurological Surgery, Thomas Jefferson Hospital, Philadelphia, Pennsylvania, USALee Pride - Department of Neuroradiology, University of Texas Southwestern, Dallas, Texas, USAAquilla S Turk - Medical University of South Carolina, Charleston, South Carolina, USAHenry H Woo - Department of Neurosurgery, State University of New York at Stony Brook, Stony Brook, New York, USAColin Derdeyn - Washington University, St. Louis, Missouri, USAJohn Millar - Department of Neuroradiology, Wessex Neurological Centre, Southampton, UKAndrew Clifton - St Georges Hospital Medical School, London, UK
- Resource Type
- Journal article
- Publication Details
- Journal of neurointerventional surgery, Vol.8(9), pp.894-897
- DOI
- 10.1136/neurintsurg-2015-011937
- PMID
- 26391016
- ISSN
- 1759-8478
- eISSN
- 1759-8486
- Language
- English
- Date published
- 09/2016
- Academic Unit
- Neurology; Radiology; Iowa Neuroscience Institute; Neurosurgery
- Record Identifier
- 9984020790202771
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