Chronic Total Occlusion of Coronary Artery Clinical Trial
Official title:
A Single-Arm Study to Assess the Safety and Efficacy of the SoundBite™ Crossing System With ACTIVE Wire in Coronary Chronic Total Occlusions (the ACTIVE Trial).
The objective of this study is to evaluate the safety and efficacy of the SoundBite™ Crossing System - Coronary (SCS-C) in a subject population with chronic coronary artery disease including Chronic Total Occlusion (CTO).
The study is intended to demonstrate that the SoundBite™ Crossing System - Coronary can facilitate the passage of either 1) devices intended to treat a CTO or 2) guidewires or additional crossing devices into the true lumen distal to the CTO. SoundBite™ Crossing System - Coronary, which consists of a re-usable console and a disposable device (ACTIVE Wire). The SoundBite™ Crossing System - Coronary is intended to facilitate passage of a guidewire or therapeutic devices through a coronary artery Chronic Total Occlusion. This is a prospective, multi-center, multinational, single-arm, phased clinical study intended to provide pivotal data for device approval. ;
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