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Prospective Study of the SoundBite™ Crossing System in Complex Peripheral CTOs — PROSPECTORII  

Peripheral Arterial Occlusive Disease Clinical Trial

Official title:
Prospective Study on the Clinical Effectiveness, Safety, Cost Benefits, and Outcomes of the SoundBite™ Crossing System in Complex Peripheral CTOs - The PROSPECTOR II Study

Clinical Trial Summary

This study aims at assessing additional performance characteristics of the SoundBite™ Crossing System with regards to the luminal passage of complex Chronic Total Occlusions (CTO) by evaluating clinically relevant efficacy, safety, cost benefit and treatment pathway endpoints.

Clinical Trial Description

This multinational study will be based on observational cases with descriptive statistics to collect data on safety and efficacy based on clinical use of the SoundBite™ Crossing System. This study will include a cost benefit analysis that will focus on wire and other Percutaneous Transluminal Angioplasty (PTA) device usage during the procedure. The cost benefit will be compared to the sites data on their average costs for CTO crossing cases. The planned treatment pathway elected prior to procedure will be compared to subject's treatment pathway plan post -procedure (discharge, surgeries such as bypass, amputation etc.) will be collected to determine patient outcomes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03933657
Study type Interventional
Source SoundBite Medical Solutions, Inc.
Contact
Status Withdrawn
Phase N/A
Start date December 30, 2022
Completion date September 30, 2023
View Details
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