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

J Neurointerv Surg. 2019 Sep;11(9):924-930. doi: 10.1136/neurintsurg-2019-014815. Epub 2019 Apr 16.


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.

Keywords: aneurysm; blood flow; coil; device; magnetic resonance angiography.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Aneurysm, Ruptured / diagnostic imaging
  • Aneurysm, Ruptured / surgery
  • Embolization, Therapeutic / instrumentation
  • Embolization, Therapeutic / methods
  • Endovascular Procedures / instrumentation*
  • Endovascular Procedures / methods*
  • Female
  • Follow-Up Studies
  • Humans
  • Intracranial Aneurysm / diagnostic imaging*
  • Intracranial Aneurysm / surgery*
  • Intracranial Aneurysm / therapy
  • Male
  • Middle Aged
  • Prospective Studies
  • Prostheses and Implants
  • Time Factors
  • Treatment Outcome

Associated data