Trials / Recruiting
RecruitingNCT05551780
Treatment of Calcific Total Occlusions in Peripheral Artery Disease
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- SoundBite Medical Solutions, Inc. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, multi-center, non-randomized, open label, clinical study intended to provide data to demonstrate safety and performance of the SoundBite Crossing System XS Peripheral.
Detailed description
The CaTO-PAD study includes a below-the-knee (BTK) sub-study (CaTO-BTK)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SoundBite Crossing System | Use of the SoundBite Crossing System to cross calcified chronic total occlusions |
Timeline
- Start date
- 2023-02-21
- Primary completion
- 2024-11-01
- Completion
- 2024-12-01
- First posted
- 2022-09-23
- Last updated
- 2024-06-13
Locations
5 sites across 3 countries: United States, Austria, Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05551780. Inclusion in this directory is not an endorsement.