作者
Christopher J Kwolek, Michael R Jaff, J Ignacio Leal, L Nelson Hopkins, Rasesh M Shah, Todd M Hanover, Sumaira Macdonald, Richard P Cambria, Angel Flores, Ignacio Leal, Antonio Orgaz, Richard Cambria, Mark Conrad, Christopher Kwolek, Glenn LaMuraglia, Elad Levy, Adnan Siddiqui, Kenneth Snyder, Rasesh Shah, Christopher Stout, Mark Androes, Bruce Gray, Tod Hanover, Manny Mehta, Dawn Coleman, Enrique Criado, Katherine Gallagher, Vikram Kashyap, Russell Becker, Nitin Malhotra, Robert Molnar, Mahmoud Malas, Jim Melton, Brian DeRubertis, Wes Moore, William Quinones-Baldrich, Peter Morton, Jeffrey Apple, Mazin Foteh, Jeffrey Jim, Brian Rubin, Sam Ahn, Robert Feldtman, Kenneth Kollenmeyer, Daniel Clair, Sean Lyden, Edward Connolly, Philip Meyers, Nick Morrisey, Anthony Pucillo, Gary Ansel, Jefferson Lyons, Mitchell Silver, Michael Jaff, Daryl Gress, William Gray
发表日期
2015/11/1
期刊
Journal of vascular surgery
卷号
62
期号
5
页码范围
1227-1234. e1
出版商
Mosby
简介
Objective
This report presents the 30-day results of the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial and evaluates the safety and efficacy of ENROUTE Transcarotid NPS (Silk Road Medical Inc, Sunnyvale, Calif), a novel transcarotid neuroprotection system that provides direct surgical common carotid access and cerebral embolic protection via high-rate flow reversal during carotid artery stenting (CAS).
Methods
A prospective, single-arm, multicenter clinical trial was performed to evaluate the use of the ENROUTE Transcarotid NPS during CAS procedures performed in patients considered to be at high risk for complications from carotid endarterectomy. Symptomatic patients with ≥50% stenosis and asymptomatic patients with ≥70% stenosis were eligible to be treated with any U.S. Food and Drug Administration-approved carotid artery stent …
学术搜索中的文章
CJ Kwolek, MR Jaff, JI Leal, LN Hopkins, RM Shah… - Journal of vascular surgery, 2015