The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms

Final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study

Adam Arthur, Andy Molyneux, Alexander L. Coon, Isil Saatci, Istvan Szikora, Feyyaz Baltacioglu, Ali Sultan, Daniel Hoit, Josser E. Delgado Almandoz, Lucas Elijovich, Saru Cekirge, James V. Byrne, David Fiorella

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Introduction: The Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, single-arm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms. Methods: One-hundred and fifty patients with wide-neck bifurcation aneurysms were enrolled at 21 US and six international centers. Angiograms from the index procedure, and 6-month and 1-year follow-up visits were all reviewed by a core laboratory. All adverse events were reviewed and adjudicated by a clinical events adjudicator. A data monitoring committee provided oversight during the trial to ensure subject safety. Results: One-hundred and forty-eight patients received the WEB implant. One (0.7%) primary safety event occurred during the study - a delayed ipsilateral parenchymal hemorrhage - on postoperative day 22. No primary safety events occurred after 30 days through 1 year. At the 12-month angiographic follow-up, 77/143 patients (53.8%) had complete aneurysm occlusion. Adequate occlusion was achieved in 121/143 (84.6%) subjects. Conclusions: The prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial were met. The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer. Trial registration number: NCT02191618

Original languageEnglish (US)
JournalJournal of neurointerventional surgery
DOIs
StatePublished - Jan 1 2019

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Aneurysm
Safety
Neck
Equipment and Supplies
Clinical Trials Data Monitoring Committees
Therapeutics
Postoperative Hemorrhage
Angiography

All Science Journal Classification (ASJC) codes

  • Surgery
  • Clinical Neurology

Cite this

The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms : Final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study. / Arthur, Adam; Molyneux, Andy; Coon, Alexander L.; Saatci, Isil; Szikora, Istvan; Baltacioglu, Feyyaz; Sultan, Ali; Hoit, Daniel; Delgado Almandoz, Josser E.; Elijovich, Lucas; Cekirge, Saru; Byrne, James V.; Fiorella, David.

In: Journal of neurointerventional surgery, 01.01.2019.

Research output: Contribution to journalArticle

Arthur, Adam ; Molyneux, Andy ; Coon, Alexander L. ; Saatci, Isil ; Szikora, Istvan ; Baltacioglu, Feyyaz ; Sultan, Ali ; Hoit, Daniel ; Delgado Almandoz, Josser E. ; Elijovich, Lucas ; Cekirge, Saru ; Byrne, James V. ; Fiorella, David. / The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms : Final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study. In: Journal of neurointerventional surgery. 2019.
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abstract = "Introduction: The Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, single-arm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms. Methods: One-hundred and fifty patients with wide-neck bifurcation aneurysms were enrolled at 21 US and six international centers. Angiograms from the index procedure, and 6-month and 1-year follow-up visits were all reviewed by a core laboratory. All adverse events were reviewed and adjudicated by a clinical events adjudicator. A data monitoring committee provided oversight during the trial to ensure subject safety. Results: One-hundred and forty-eight patients received the WEB implant. One (0.7{\%}) primary safety event occurred during the study - a delayed ipsilateral parenchymal hemorrhage - on postoperative day 22. No primary safety events occurred after 30 days through 1 year. At the 12-month angiographic follow-up, 77/143 patients (53.8{\%}) had complete aneurysm occlusion. Adequate occlusion was achieved in 121/143 (84.6{\%}) subjects. Conclusions: The prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial were met. The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer. Trial registration number: NCT02191618",
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AU - Molyneux, Andy

AU - Coon, Alexander L.

AU - Saatci, Isil

AU - Szikora, Istvan

AU - Baltacioglu, Feyyaz

AU - Sultan, Ali

AU - Hoit, Daniel

AU - Delgado Almandoz, Josser E.

AU - Elijovich, Lucas

AU - Cekirge, Saru

AU - Byrne, James V.

AU - Fiorella, David

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AB - Introduction: The Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, single-arm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms. Methods: One-hundred and fifty patients with wide-neck bifurcation aneurysms were enrolled at 21 US and six international centers. Angiograms from the index procedure, and 6-month and 1-year follow-up visits were all reviewed by a core laboratory. All adverse events were reviewed and adjudicated by a clinical events adjudicator. A data monitoring committee provided oversight during the trial to ensure subject safety. Results: One-hundred and forty-eight patients received the WEB implant. One (0.7%) primary safety event occurred during the study - a delayed ipsilateral parenchymal hemorrhage - on postoperative day 22. No primary safety events occurred after 30 days through 1 year. At the 12-month angiographic follow-up, 77/143 patients (53.8%) had complete aneurysm occlusion. Adequate occlusion was achieved in 121/143 (84.6%) subjects. Conclusions: The prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial were met. The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer. Trial registration number: NCT02191618

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