Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT03266835
Brief 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.
Study:
NCT03266835
Study Brief:
Protocol Section:
NCT03266835