Intraluminal Recanalization of Long Infrainguinal Chronic Total Occlusions Using the Crosser System

PURPOSE: To assess the safety and efficacy of a device for vibrational angioplasty in the percutaneous intraluminal recanalization of long infrainguinal chronic total occlusions (CTO). TECHNIQUE: The Crosser CTO Recanalization System is a mechanical recanalization device that uses high-frequency vibrational energy to disrupt and channel through fibrocalcific plaque without harming the vessel wall, thus assisting in the recanalization of an occluded artery. In 12 diabetic patients (7 men; median age 71 years, range 58-80) with critical limb ischemia owing to long (median length 26 cm, range 21-32) infrainguinal CTOs resistant to conventional guidewire techniques, the Crosser CTO Recanalization System was successful in intraluminally crossing the occlusion in 9 (75%) patients in <5 minutes (mean 4:03 minutes). The safety endpoint (distal lumen guidewire position with no vessel perforation or dissection) was achieved in all successful cases. CONCLUSION: In our preliminary experience, the Crosser CTO Recanalization Catheter decreased crossing time, was safe, and achieved a high rate of intraluminal recanalization of long infrainguinal CTOs.