Unique ID issued by UMIN | UMIN000027897 |
---|---|
Receipt number | R000031952 |
Scientific Title | Clinical study for Plasma Wire System (FIM-2) |
Date of disclosure of the study information | 2017/06/23 |
Last modified on | 2017/06/23 16:04:00 |
Clinical study for Plasma Wire System (FIM-2)
FIM-2
Clinical study for Plasma Wire System (FIM-2)
FIM-2
Japan |
Chronic total occlusion
Cardiology |
Others
NO
To achieve CTO penetration of antegrade wire more easily and more effectively and to confirm the safety, by penetrating into CTO inlet and true lumen or making re-entry using new RF generator with appropriate circuit, two kinds of PlasmaWire and penetration catheter W-OTW which has double OTW lumen. Moreover, to confirm the safety of PlasmaWire System in case of switching from antegrade approach to retrograde approach.
Safety,Efficacy
Confirmatory
Efficacy of the device, antegrade procedure success and patient success.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
-
20 | years-old | <= |
Not applicable |
Male and Female
-
-
10
1st name | |
Middle name | |
Last name | Kenya Nasu |
Toyohashi Heart Center
Cardiovascular Medicine
21-1 Gobudori, Oyama-Cho, Toyohashi, Aichi 441-8530 Japan
0532-37-3377
nasu@heart-center.or.jp
1st name | |
Middle name | |
Last name | Kenya Nasu |
Toyohashi Heart Center
Cardiovascular Medicine
21-1 Gobudori, Oyama-Cho, Toyohashi, Aichi 441-8530 Japan
0532-37-3377
nasu@heart-center.or.jp
Toyohashi Heart Center
Cardiovascular Medicine
Toyohashi Heart Center
Cardiovascular Medicine
Self funding
NO
2017 | Year | 06 | Month | 23 | Day |
Unpublished
Open public recruiting
2017 | Year | 06 | Month | 20 | Day |
2017 | Year | 06 | Month | 30 | Day |
2017 | Year | 06 | Month | 23 | Day |
2017 | Year | 06 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031952