NCT03266835

SoundBite™ Crossing System Pivotal Peripheral CTO Crossing Study

A Multinational, Single-Arm Pivotal Study to Assess the Performance Rate Of SoundBite™ Active Wire for PEripheral Chronic Total Occlusion Recanalization (PROSPECTOR)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: SoundBite Medical Solutions, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is aimed at demonstrating the efficacy and safety of the SoundBite™ Crossing System-Peripheral. The study is intended to demonstrate that the SoundBite™ Crossing System can facilitate the passage of either devices intended to treat a chronic total occlusion (CTO) or additional crossing devices through an infrainguinal CTO into the true lumen.

Detailed description

This is a multinational, single-arm, pivotal trial assessing the efficacy and safety of the SoundBite™ Crossing System - Peripheral. The enrollment will consist of up to 100 patients meeting the inclusion/exclusion criteria in order to obtain 90 evaluable patients for efficacy and safety analysis. The primary endpoints will be compared to literature-based performance goals to establish study success. Objective Performance Goals (OPG) have been obtained from a literature based review. Reports published in the past 10 years were reviewed for both safety and effectiveness in crossing infrainguinal CTO. The studies reviewed generally have one primary composite safety endpoint and one primary efficacy endpoint. Some studies have performed formal hypothesis testing versus a pre-specified performance goal for one or both endpoints.

Conditions

• Chronic Total Occlusion of Arteries of the Extremities

Interventions

Type	Name	Description
DEVICE	SoundBite™ Crossing System - Peripheral	SoundBite™ Crossing System consisting of the SoundBite™ Console and SoundBite™ Active Wire 18. The Investigator may use the SoundBite™ Active Wire during the procedure to cross the proximal aspect and/or to cross multiple lesions.

Timeline

• Start date: 2017-11-16
• Primary completion: 2019-01-18
• Completion: 2019-01-18
• First posted: 2017-08-30
• Last updated: 2019-04-25

Locations

2 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study