Prospective Study on the Clinical Effectiveness, Safety, Cost Benefits, and Outcomes of the SoundBite™ Crossing System in Complex Peripheral CTOs - The PROSPECTOR II Study
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.
• Has symptomatic non-acute limb ischemia, requiring treatment of an infrainguinal artery
• Has Rutherford Clinical Category of 2-6
• is able and willing to provide written informed consent prior to study procedure
⁃ Angiographic Inclusion Criteria
• 100% stenosis by a visual estimate of angiography at the time of the procedure
• target CTO has moderate to severe calcification
• Has at least one of the following: severe calcification, flush occlusion, femoropopliteal CTOs with reconstitution below Popliteal 2-3, side directing collateral at the proximal cap, long (≥ 5cm) occlusions, below the knee (BTK) occlusion.
• Has evidence of a clinically significant CTO located in a peripheral vessel below the infrainguinal ligament confirmed by angiography at time of the procedure.