title: Demographic, procedural and 30-day safety results from the WEB Intra-saccular Therapy Study (WEB-IT).
abstract: BACKGROUND
  The Woven EndoBridge (WEB) represents a novel intrasaccular therapeutic option for the treatment of intracranial wide-necked bifurcation aneurysms (WNBAs). The WEB-IT Study is a pivotal Investigational Device Exemption (IDE) study to determine the safety and effectiveness of the WEB device for the treatment of WNBAs located in the anterior and posterior intracranial circulations. We present the patient demographics, procedural characteristics, and 30-day adverse event data for the US WEB-IT study.
  
  
  METHODS
  WEB-IT is a prospective multicenter single-arm interventional study conducted at 25 US and 6 international centers. The study enrolled 150 adults with WNBAs of the anterior and posterior intracranial circulations. All patients were intended to receive a WEB device delivered via standard endovascular neurosurgical embolization techniques. The study was conducted under Good Clinical Practices and included independent adjudication effectiveness outcomes and all adverse events.
  
  
  RESULTS
  One hundred and fifty patients enrolled at 27 investigational sites underwent attempted treatment with the WEB. Mean age was 59 years (range 29-79) and 110 (73.3%) of the patients were female. Treated aneurysms were located at the basilar apex (n=59, 39.3%), middle cerebral artery bifurcation (n=45, 30%), anterior communicating artery (n=40, 26.7%), and internal carotid artery terminus (n=6, 4%). Average aneurysm size was 6.4 mm (range 3.6-11.4) with a mean neck size of 4.8 mm (range 2.0-8.2, mean dome to neck ratio 1.34). Nine patients presented with ruptured aneurysms. Of the enrolled patients, 98.7% were treated successfully with WEB devices. Mean±SD fluoroscopy time was 30.2±15.7 min. One primary safety event (PSE) (0.7%)-a delayed parenchymal hemorrhage 22 days after treatment-occurred between the index procedure and 30-day follow-up. In addition to the single PSE, there were seven (4.7%) minor ischemic strokes (5 resolved without sequelae and 2 had a modified Rankin Scale score of 1 at 30 days), five (2.7%) transient ischemic attacks, and two (1.3%) minor subarachnoid hemorrhages, which did not meet the prospectively established criteria for PSEs.
  
  
  CONCLUSIONS
  The WEB device can be used to treat WNBAs with a high level of procedural safety and a high degree of technical success.
  
  
  BACKGROUND
  NCT02191618; Pre-results.
authors.affiliation: Department of Neurosurgery, State University of New York at Stony Brook, Stony Brook, New York, USA.
authors.forename: David
authors.initials: D
authors.lastname: Fiorella
authors.affiliation: Oxford Neurovascular and Neuroradiology Research Unit, Oxford Radcliffe Hospital, Oxford, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Molyneux
authors.affiliation: Johns Hopkins University School of Medicine, The Johns Hopkins Hospital, Baltimore, Maryland, USA.
authors.forename: Alexander
authors.initials: A
authors.lastname: Coon
authors.affiliation: National Institute of Neurosciences, Budapest, Hungary.
authors.forename: Istvan
authors.initials: I
authors.lastname: Szikora
authors.affiliation: Private Koru Hospital, Ankara, Turkey.
authors.forename: Isil
authors.initials: I
authors.lastname: Saatci
authors.affiliation: Marmara University Faculty of Medicine Pendik Training and Research Hospital, Istanbul, Turkey.
authors.forename: Feyyaz
authors.initials: F
authors.lastname: Baltacioglu
authors.affiliation: Department of Neurosurgery, Brigham and Women's Hospital, Boston, Massachusetts, USA.
authors.forename: Ali
authors.initials: A
authors.lastname: Sultan
authors.affiliation: Semmes-Murphey Neurologic and Spine Institute, University of Tennessee Department of Neurosurgery, Memphis, Tennessee, USA.
authors.forename: Adam
authors.initials: A
authors.lastname: Arthur
mesh_terms: D000328:Adult; D000368:Aged; D017542:Aneurysm, Ruptured / Q000000981:diagnostic imaging / Q000601:surgery; D020771:Anterior Cerebral Artery / Q000000981:diagnostic imaging / Q000601:surgery; D002343:Carotid Artery, Internal / Q000000981:diagnostic imaging / Q000601:surgery; D003710:Demography / Q000639:trends*; D004621:Embolization, Therapeutic / Q000295:instrumentation; D057510:Endovascular Procedures / Q000295:instrumentation* / Q000379:methods / Q000639:trends*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D002532:Intracranial Aneurysm / Q000000981:diagnostic imaging* / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D020768:Middle Cerebral Artery / Q000000981:diagnostic imaging / Q000601:surgery; D011446:Prospective Studies; D000069322:Self Expandable Metallic Stents / Q000639:trends*; D016896:Treatment Outcome
keywords: Aneurysm; Device; Flow Diverter; Hemorrhage