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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
- aneurysm
- blood flow
- coil
- device
- magnetic resonance angiography
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Contributors All authors of this work met International Committee of Medical Journal Editors criteria for authorship and made substantial contributions to the conception and design, acquisition of data, analysis and interpretation of data, drafting, critical revising, and final approval of this manuscript.
Funding The WEB-IT Study was supported by Sequent Medical Inc, Aliso Viejo, California, USA.
Competing interests The principal investigators for the WEB-IT trial received institutional salary support for study-related activities. Investigators in the WEB-IT trial also received payment for proctoring cases within the context of the trial. ASA is a consultant for Balt, Johnson and Johnson, Leica, Medtronic, Microvention, Penumbra, Scientia, Siemens, and Stryker; receives research support from Microvention, Penumbra, and Siemens; and is a shareholder in Bendit, Cerebrotech, Endostream, Magneto, Marblehead, Neurogami, Serenity, Synchron, Triad Medical and Vascular Simulations outside the submitted work. AM is a consultant for Microvention/Sequent, Stryker Neurovascular, and Cerus outside the submitted work. ALC is a consultant for Medtronic, Microvention, and Stryker Neurovascular outside the submitted work. IS is a consultant for Medtronic and Sequent/Microvention outside the published work. IS is a consultant for Sequent/Microvention, Stryker, Medtronic, and Cerenovus outside the submitted work. DH is a consultant for Covidien/Medtronic and Microvention outside the submitted work and has received research support from Siemens. JEDA is a consultant for Medtronic, Penumbra, and Sequent outside the submitted work. LE is a consultant for Codman Neurovascular, Medtronic, MicroVention, Penumbra, Sequent, and Stryker outside the submitted work. SC is a consultant for Medtronic and Sequent/MicroVention outside the submitted work and is a stockholder in ELUM and NDI. JVB provided core laboratory services to Sequent through Oxford University during the conduct of this study and now acts as a consultant for MicroVention and Oxford Endovascular; he is a stockholder of Oxford Endovascular outside the submitted work. DF is a consultant for Balt, Marblehead, Medtronic, Stryker, Microvention, Stryker, Penumbra, and Cerenovus; receives research support from Cerenovus, Medtronic, Stryker, Siemens, Microvention, and Penumbra, and royalties from Codman; and is a stockholder for Marblehead, Neurogami, and Vascular Simulations outside the submitted work.
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators Participating centers with principal investigator (PI) and co-investigator (Co-PI) in order of enrollment (No.): Methodist University Hospital Neuroscience Institute & Cancer Center, Memphis, Tennessee, USA (21), PI: Adam Arthur, MD, Sub-I: Daniel Hoit, MD, Lucas Elijovich, MD; Stony Brook University Medical Center, Stony Brook, NY, United States (12), PI: David Fiorella, MD, Sub-I: Henry Woo, MD; The Johns Hopkins Hospital, Baltimore, MD, United States (12) PI: Alexander Coon, MD, Sub-I: Geoffrey Colby, MD; Koru Hospital, Ankara, Turkey (11) PI: Isil Saatci, MD, Sub-I: Saruhan Cekirge, MD; National Institute of Neurosciences, Budapest, Hungary (10) PI: Istvàn Szikora, MD; Marmara University Faculty of Medicine Pendik Training and Research Hospital, Istanbul, Turkey (9) PI: Feyyaz Baltacioğlu, MD, Sub-I: Ruslan Asadov, MD; Brigham and Women’s Hospital, Boston, Massachusetts, USA (8), PI: Ali Sultan, MD, Sub-I: Ram Chavali, MD, Kai Frerich, MD; Abbott Northwestern Hospital, Minneapolis, Minnesota, USA (7), PI: Josser Delgado, MD, Sub-I: Yasha Kayan, MD; Lyerly Neurosurgery, Baptist Medical Center, Jacksonville, Florida, USA (7), PI: Ricardo Hanel, MD, Sub-I: Eric Sauvageau, MD; Medical University of South Carolina, Charleston, South Carolina, USA (7), PI: Raymond Turner, MD, Sub-I: Imran Chaudry, MD, Alejandro Spiotta, MD, Aquila Turk, MD; West Virginia University Medical Center, Morgantown, Virginia, USA (6) PI: Ansaar Rai, MD, Sub-I: Jeffrey Carpenter, MD, Sohyun Boo, MD; Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA (6), PI: Pascal Jabbour, MD, Sub-I Stavropoula Tjoumakaris, MD, Robert Rosenwasser, MD; Fort Sanders Regional Medical Center, Knoxville, Tennessee, USA (5), PI: Keith Woodward, MD; Albany Medical Center, Albany, New York, USA (4) PI: Alan Boulos, MD, Sub-I: John Dalfino, MD, Junichi Yamamoto, MD; Riverside Methodist Hospital, Columbus, Ohio, USA (4) PI: Nirav Vora, MD, Sub-I: Ronald Budzik, MD, Peter Pema, MD, Thomas Davis, DO; Baptist Memorial Hospital, Memphis, Tennessee, USA (3), PI: Daniel Hoit, MD, Sub-I: Adam Arthur, MD, Lucas Elijovich, MD; Mayo Clinic, Rochester, Minnesota, USA (3): PI: David Kallmes, MD, Sub-I: Giuseppe Lanzino, MD, Harry Cloft, MD; University at Buffalo Medical Center, Buffalo, New York, USA (2), PI: Adnan Siddiqui, MD, Sub-I: Elad Levy, MD, Kenneth Snyder, MD; Rush University Medical Center, Chicago, Illinois, USA (2), PI: Demetrius Lopes, MD, Sub-I: Michael Chen, MD; Mount Sinai Roosevelt Hospital, New York, New York, USA (2) PI: JD Mocco, MD, Sub-I: Johanna Fifi, MD; University of Texas Medical School, Houston, Texas, USA (2) PI: Peng Roc Chen, MD; Royal University Hospital, Saskatoon, Canada (2), PI: Michael Kelly, MD, Sub-I: Lissa Peeling, MD; Swedish Medical Center, Englewood, Colorado, USA (1) PI: Don Frei, MD, Sub-I: Daniel Huddle, DO, Richard Bellon, MD, David Loy, MD; Barrow Neurological Institute, St Joseph’s Hospital and Medical Center, Phoenix, Arizona, USA (1) PI: Felipe Albuquerque, MD, Sub-I: Andrew Ducruet, MD; Righospitalet, University of Copenhagen, Copenhagen, Denmark (1), PI: Marcus Holtmannspötter, MD; University of Louisville Hospital, Louisville, Kentucky, USA (1), PI: Robert James, MD, Sub-I: Wei Liu, MD; Helios General Hospital, Erfurt, Germany (1) PI: Joachim Klisch, MD, Sub-I: Christoph Strasilla, MD, Christin Clajus, MD. Study proctors in order of cases Proctored (No.): Adam Arthur MD MPH (18), Daniel Hoit MD MPH (15), Saleh Lamin MD (8), Allan Thomas MD (8), David Fiorella MD PhD (8), Josser Delgado MD (7), Tufail Patankar MD (6), Markus Holtmannspotter MD (4), Lucas Elijovich MD (4), Alexander Coon MD (4), Ansgar Berlis MD (1), Imran Chaudry MD (1).
Patient consent for publication Not required.