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ABSTRACT: Objectives
To determine the safety and effectiveness of a peripheral artery chronic total occlusion (CTO) crossing catheter following failed crossing attempts with standard guidewires.Background
CTO crossing remains a challenge during peripheral artery interventions.Methods
In this prospective, international, single-arm study, patients with a peripheral artery CTO that was uncrossable with standard guidewires were treated with a crossing catheter (Wingman, Reflow Medical). The primary efficacy endpoint of CTO crossing success was compared to a performance goal of 70.7%. The primary composite safety endpoint (major adverse event [MAE], clinically significant perforation or embolization, or grade C or greater dissection) was assessed over a 30-day follow-up period and
SUBMITTER: Laird JR
PROVIDER: S-EPMC7984280 | biostudies-literature | 2021 Feb
REPOSITORIES: biostudies-literature