Objectives: The aim of this study was to evaluate the safety and effectiveness of a 0.010-inch guidewire and a balloon catheter for treatment of chronic total occlusion (CTO).
Background: Pathological studies have shown that 60-70% of CTO lesions have microchannels of sizes equal to or less than 0.010 inch.
Methods: The PIKACHU registry is a prospective, multicenter registry study. A 0.010-inch guidewire had to be used as the first guidewire to attempt to pass the CTO lesion. The primary endpoint was device success using a 0.010 system.
Results: A total of 141 patients with 141 lesions were enrolled. The median duration of occlusion was 9 months (range 3-156). Average guiding catheter size was 5.8 +/- 0.7 Fr. and TRI was 76.6 %. CTOs were mostly between 10-20 mm long, observed in 53 occlusions. There were 107 lesions (75.9%) with bending of more than 45 degrees. Calcification was seen in 91 lesions (64.5%). A 0.010-inch guidewire was successfully passed through in 97 of 141 lesions (68.8%). A 0.010-inch guidewire compatible balloon catheter was passed in 87 of the 97 lesions (88.7%) and final PCI success was achieved in all the cases. The overall clinical success rate was 87.9% (124/141). No MACE or bleeding complications were observed.
Conclusion: The PIKACHU registry data suggest that the 0.010-inch system is safe and practicable for treatment of CTO lesions.