Trials / Withdrawn
WithdrawnNCT03933657
Prospective Study of the SoundBite™ Crossing System in Complex Peripheral CTOs
Prospective Study on the Clinical Effectiveness, Safety, Cost Benefits, and Outcomes of the SoundBite™ Crossing System in Complex Peripheral CTOs - The PROSPECTOR II Study
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- SoundBite Medical Solutions, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
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
- 2022-12-30
- Primary completion
- 2023-09-30
- Completion
- 2023-09-30
- First posted
- 2019-05-01
- Last updated
- 2023-09-14
Locations
2 sites across 2 countries: Austria, Germany
Source: ClinicalTrials.gov record NCT03933657. Inclusion in this directory is not an endorsement.