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A prospective multicenter registry of 0.010-inch guidewire and compatible system for chronic total occlusion: The PIKACHU registry

2010; Wiley; Volume: 75; Issue: 7 Linguagem: Inglês

10.1002/ccd.22434

1522-726X

Takashi Matsukage, Motomaru Masutani, Fuminobu Yoshimachi, Akihiko Takahashi, Takaaki Katsuki, Shigeru Saito, Hidenobu Terai, Yoshiaki Katahira, Yoshiki Uehara, Satoru Tohara, Yurika Ohba, Shoichi Shinohara, Hiroshi Asano, Toshiyuki Matsumura, Tetsuya Hata, Yuji Ikari,

Peripheral Artery Disease Management

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).Pathological studies have shown that 60-70% of CTO lesions have microchannels of sizes equal to or less than 0.010 inch.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.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.The PIKACHU registry data suggest that the 0.010-inch system is safe and practicable for treatment of CTO lesions.