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E-044 web-sl/sls® aneurysm treatment: one-month safety results in webcast2 study
  1. L Pierot,
  2. A Molyneux,
  3. J Byrne,
  4. W Investigators
  1. Radiology, Hôpital Maison-Blanche, Reims, France

Abstract

Purpose WEB flow disruption is an innovative endovascular treatment for wide-neck bifurcation aneurysms. WEBCAST1 analyzed the safety and efficacy of the WEB-DL device. WEBCAST2 is dedicated to the safety and efficacy analysis of the WEB-SL and WEB-SLS device.

Methods WEBCAST2 is a prospective, multicenter, European study involving 13 Interventional Neuroradiology centers. Patients with bifurcation aneurysms are included in WEBCAST2. Aneurysm locations included in WEBCAST2 are middle cerebral artery, internal carotid artery terminus, anterior communicating artery, posterior communicating artery, and basilar tip. Patients with ruptured and unruptured aneurysms are included. All adverse events are collected and will be analyzed by an independent medical monitor. Morbidity and mortality will be analyzed at 1, 6, and 12 months. Follow-up imaging will be obtained at 6 and 12 months and up to 5 years, and independently analyzed by an expert in Interventional Neuroradiology. The goal is to enroll up to 60 patients. An intermediate analysis will be conducted after inclusion of 50 patients.

Results Inclusions started in August 2014. As of March 9, 43 patients were included. The expectation is to have 50 evaluable patients included end of May. One-month clinical follow-up will be completed end of June. One-month safety data will be presented and analyzed in comparison with other WEB Good Clinical Practice (GCP) Data (WEBCAST1 and French Observatory that included patients treated with both WEB-DL and WEB-SL/SLS).

Conclusion WEBCAST2 is an ongoing study evaluating WEB-SL/SLS aneurysm treatment. Inclusion completion is expected end of May. One-month safety data will be presented and analyzed in light of previous GCP studies (WEBCAST1 and French Observatory).

Disclosures L. Pierot: 2; C; Sequent. A. Molyneux: 2; C; Sequent. J. Byrne: 2; C; Sequent. W. Investigators: None.

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