NCT03521804

Safety and Efficacy Study of the SoundBite™ Crossing System With ACTIVE Wire in Coronary CTOs.

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).

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: SoundBite Medical Solutions, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Chronic Total Occlusion of Coronary Artery

Interventions

Type	Name	Description
DEVICE	SoundBite™ Crossing System Active Wire 14	Successful crossing of the CTO into the true arterial lumen distal to the occlusion, following use of the SoundBite™ Crossing Wire during the procedure and using antegrade only approach. An antegrade only approach may involve Antegrade Dissection Re-Entry (ADR) with or without the use of specialized devices (i.e. Stingray). The absence of successful retrograde crossing of a collateral will still be considered an antegrade only approach.

Timeline

• Start date: 2018-06-21
• Primary completion: 2020-10-21
• Completion: 2020-11-20
• First posted: 2018-05-11
• Last updated: 2023-12-06

Locations

5 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study