Treatment of Calcific Total Occlusions in Peripheral Artery Disease
SoundBite Medical Solutions, Inc.
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.
Description
The CaTO-PAD study includes a below-the-knee (BTK) sub-study (CaTO-BTK)
Eligibility
- Age range
- 19+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Scheduled for interventional treatment of de-novo lesion(s) of the following native arteries: 1. CaTO-PAD: infrainguinal 2. CaTO-BTK: infrapopliteal 2. Have at least one chronic total occlusion (CTO) with no flow observed in the distal lesion except the flow from collateral circulation 3. Presenting with the following: 1. CaTO-PAD: claudication or CLI (Rutherford Clinical Category 2-5) of the target limb 2. CaTO-BTK Sub-Study: - Category 4 or 5 only for CaTO-BTK Sub-Study CaTO-PAD: claudication or CLI (Rutherford Clinical Category 2-5) of the target limb 4…
Interventions
- DeviceSoundBite Crossing System
Use of the SoundBite Crossing System to cross calcified chronic total occlusions
Locations (5)
- Palm Vascular CentersFort Lauderdale, Florida
- UNC REX HospialRaleigh, North Carolina
- Lifespan - The Miriam HospitalProvidence, Rhode Island
- Medizinische Universität GrazGraz
- Angiology Clinic and Vascular CentreArnsberg