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


CONCLUSIONS
The PIKACHU registry data suggest that the 0.010-inch system is safe and practicable for treatment of CTO lesions.
Matsukage
Takashi
T
Department of Cardiology, Tokai University School of Medicine, Isehara, Japan.
Masutani
Motomaru
M
Yoshimachi
Fuminobu
F
Takahashi
Akihiko
A
Katsuki
Takaaki
T
Saito
Shigeru
S
Terai
Hidenobu
H
Katahira
Yoshiaki
Y
Uehara
Yoshiki
Y
Tohara
Satoru
S
Ohba
Yurika
Y
Shinohara
Shoichi
S
Asano
Hiroshi
H
Matsumura
Toshiyuki
T
Hata
Tetsuya
T
Ikari
Yuji
Y
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002908:Chronic Disease; D054059:Coronary Occlusion / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D006331:Heart Diseases / Q000209:etiology; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D008904:Miniaturization; D011446:Prospective Studies; D012042:Registries; D016896:Treatment Outcome