3D PRINTING BEFORE ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS AS A TOOL FOR BETTER SELECTION OF WEB DEVICES: PROTOCOL OF A RANDOMIZED CONTROLLED TRIAL

Abstract

Background

The use of new intrasaccular devices such as the Woven EndoBridge (WEB, Microvention, Aliso Viejo, USA) is expanding in the neurovascular field. The WEB device offers great advantages but it can be challenging to select the appropriate size for a specific aneurysm. 3D printing is now available in some centers for pre-surgical planning and aneurysms can be easily printed from 3D angiographies. Then, the operator can use non-sterile devices and try to position them at will until they find the best device size matching the patient lesion. During the procedure, the operator can select the device used during the pre-operative planning. We designed a randomized controlled trial (RCT) to evaluate the efficacy and safety of WEB selection by 3D printing assisted pre-operative planning.

Method

The RCT will run for 2 years, starting in October 2023, recruiting 60 patients (NCT05665309). The primary outcome will be the first deployment success defined as an adequate treatment performed with the first used device. We estimated on our historical cohort that this outcome is achieved in 60% of cases. We calculated the number of patients to include based on an efficacy of 20% more (80% of patients adequately treated with the first device). Secondary outcomes will include mid-term follow up at 3 months and safety outcomes (neurological and non-neurological complications). Seventy-five percent of patients will be randomized in the intervention group and 25% in the control group, since the control group is partly documented by the historical cohort. The study is supported by GIRCI EST «Appel à projets Emergence Jeunes Chercheurs du GIRCI Est 2021 ».

Discussion

This is the first RCT evaluating the use of 3D printing in the neurovascular field. We hope to demonstrate the efficacy of the process to secure future interventions.