TY - JOUR T1 - Neuroendovascular clinical trials disruptions due to COVID-19. Potential future challenges and opportunities JF - Journal of NeuroInterventional Surgery JO - J NeuroIntervent Surg SP - 831 LP - 835 DO - 10.1136/neurintsurg-2020-016502 VL - 12 IS - 9 AU - Ansaar T Rai AU - Thabele M Leslie-Mazwi AU - Kyle M Fargen AU - Aditya S Pandey AU - Guilherme Dabus AU - Ameer E Hassan AU - Justin F Fraser AU - Joshua A Hirsch AU - Rishi Gupta AU - Ricardo Hanel AU - Albert J Yoo AU - Hormozd Bozorgchami AU - David Fiorella AU - J Mocco AU - Adam S Arthur AU - Osama Zaidat AU - Adnan H Siddiqui Y1 - 2020/09/01 UR - http://jnis.bmj.com/content/12/9/831.abstract N2 - To assess the impact of COVID-19 on neurovascular research and deal with the challenges imposed by the pandemic.Methods A survey-based study focused on randomized controlled trials (RCTs) and single-arm studies for acute ischemic stroke and cerebral aneurysms was developed by a group of senior neurointerventionalists and sent to sites identified through the clinical trials website (https://clinicaltrials.gov/), study sponsors, and physician investigators.Results The survey was sent to 101 institutions, with 65 responding (64%). Stroke RCTs were being conducted at 40 (62%) sites, aneurysm RCTs at 22 (34%) sites, stroke single-arm studies at 37 (57%) sites, and aneurysm single-arm studies at 43 (66%) sites. Following COVID-19, enrollment was suspended at 51 (78%) sites—completely at 21 (32%) and partially at 30 (46%) sites. Missed trial-related clinics and imaging follow-ups and protocol deviations were reported by 27 (42%), 24 (37%), and 27 (42%) sites, respectively. Negative reimbursements were reported at 17 (26%) sites. The majority of sites, 49 (75%), had put new trials on hold. Of the coordinators, 41 (63%) worked from home and 20 (31%) reported a personal financial impact. Remote consent was possible for some studies at 34 (52%) sites and for all studies at 5 (8%) sites. At sites with suspended trials (n=51), endovascular treatment without enrollment occurred at 31 (61%) sites for stroke and 23 (45%) sites for aneurysms. A total of 277 patients with acute ischemic stroke and 184 with cerebral aneurysms were treated without consideration for trial enrollment.Conclusion Widespread disruption of neuroendovascular trials occurred because of COVID-19. As sites resume clinical research, steps to mitigate similar challenges in the future should be considered. ER -