A Multinational, Single-Arm Pivotal Study Assessing the Performance of the SoundBite Crossing System for Peripheral...

This study aimed to demonstrate the efficacy and safety of the SoundBite Crossing System‒Peripheral (SCS-P) to facilitate crossing chronic total occlusions (CTOs) of infrainguinal arteries.

This clinical trial was approved by the Ethics Committees of all 4 participating centers and enrolled 52 patients with symptomatic de novo infrainguinal CTOs. Technical device success, the primary efficacy endpoint, was defined as the ability to facilitate the treatment of the target lesion by crossing a portion or the whole length of the CTO. Freedom from SCS-P-related major adverse events (MAEs) at 30 days after the procedure was the primary safety endpoint.

The SCS-P met the primary efficacy and safety endpoints in 92.3% (48/52) and 100% (52/52) of subjects, respectively. Technical device success with postprocedural patency and freedom from SCS-P-related MAEs was achieved in 88.5% (46/52) of subjects. The mean CTO crossing time was 20.0 minutes ± 30.8, and the SCS-P was able to traverse the whole CTO and enter the distal true lumen without the need of any other device in 59.6% (31/52) of subjects. The mean Rutherford category and ankle-brachial index improvement at the 30-day follow-up was 2.4 ± 1.17 and 0.23 ± 0.22, respectively.

The SCS-P demonstrated a satisfactory safety and performance profile to cross peripheral CTOs and enter the distal true lumen of infrainguinal CTOs.