Intraluminal recanalization of long infrainguinal chronic total occlusions using the Crosser system.
OBJECTIVE
To assess the safety and efficacy of a device for vibrational angioplasty in the percutaneous intraluminal recanalization of long infrainguinal chronic total occlusions (CTO).


METHODS
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.


CONCLUSIONS
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.
Gandini
Roberto
R
Department of Diagnostic and Molecular Imaging, University of Rome Tor Vergata, Rome, Italy.
Volpi
Tommaso
T
Pipitone
Vincenzo
V
Simonetti
Giovanni
G
D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D002908:Chronic Disease; D003251:Constriction, Pathologic; D004867:Equipment Design; D005260:Female; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000209:etiology / Q000628:therapy*; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011859:Radiography; D016896:Treatment Outcome; D014732:Vibration