E-110 use of the vascular simulations' replicator as a physician training tool for the web-it clinical study

Abstract

The WEB is a novel intrasaccular aneurysm therapy primarily for ruptured and unruptured intracranial wide neck bifurcation aneurysms. The WEB Intrasaccular Therapy Study (WEB-IT) is the pivotal US IDE Study to demonstrate the safety and effectiveness of the therapy for US FDA approval. WEB-IT will enroll approximately 150 patients and no roll-in cases are permitted. A significant challenge of study execution is how to efficiently and effectively train an entirely new user group (US clinical investigators) on the safe and effective use of this new technology while under a clinical trial setting. The Replicator (Vascular Simulations, Stony Brook NY) is a new type of mechanical flow model which simulates the cardiac cycle and incorporates 3D replication of actual patient vasculature. The model allows simulated aneurysm treatment in a true angiographic environment. Training on the Replicator has been integrated as a key aspect of the multimodal WEB-IT Physician Training Program. Benefits of using the Replicator include: case planning (access set-up, WEB placement and deployment, dry run clinical cases with the full research team to minimize study deviations), treatment of the same or similar aneurysms as the clinical cases, a shortened learning curve, and the practice of advanced techniques and more difficult delivery options in a no risk environment. In addition, the study design will be described including study inclusion/exclusion criteria, primary safety and effectiveness endpoints, and indications for use. Disclosures A. Arthur: 6; C; Principal Investigator, Proctor, WEB-IT Study, Sequent Medical.