Unique ID issued by UMIN | UMIN000039397 |
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Receipt number | R000037570 |
Scientific Title | The Accuracy of saline-induced FFR(sFFR) instead of fractional flow reserve(FFR) to evaluate the severity of coronary stenosis. |
Date of disclosure of the study information | 2020/02/05 |
Last modified on | 2021/08/09 21:53:19 |
The Accuracy of saline-induced FFR(sFFR) instead of fractional flow reserve(FFR) to evaluate the severity of coronary stenosis.
The correlation between sFFR and FFR
The Accuracy of saline-induced FFR(sFFR) instead of fractional flow reserve(FFR) to evaluate the severity of coronary stenosis.
The correlation between sFFR and FFR
Japan |
coronary stenosis
Cardiology |
Others
NO
To evaluate the accuracy and the security of saline-induced FFR in which saline is injected rapidly to the target coronary vessel.
Safety,Efficacy
The accuracy of saline-induced FFR
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
1
Diagnosis
Food | Device,equipment |
Adding sailne-induce FFR during coronary angiography with FFR & SFR
20 | years-old | <= |
Not applicable |
Male and Female
Primary registration
Patients with coronary angiography for coronary stenosis
Secondary registration
1 Patients with coronary artery disease who undergo coronary angiography and judged having stenosis with 50% or more by 2 interventionists (at least one of them including specialists in Japanese Association of Cardiovascular Intervention and Therapeutics)
2 no particular limitation of the lesion site (left anterior descending artery, left circumflex branch, right coronary artery), history of PCI, and lesion form (in stent restenosis, calcified lesion)
3 over 20 years old
4 patients obtained document consents by the patient's will with sufficient understanding after receiving sufficient explanation for the participation of this study
1) Patients with severe valvular disease
2) Patients with decompensated heart failure
3) Patients with extreme bradycardia (HR <40 or less)
4) Patients who can not use Adenosine necessary for FFR
5) Patients with co-morbidities such as acute liver injury and renal disorder that have serious effects on life
6) coronary total occlusion
7) Patients who are judged inappropriate for participation in this study by the responsible doctor
300
1st name | Arihiro |
Middle name | |
Last name | Kiyosue |
The university of Tokyo Hospital
Cardiovascular Medicine
113-8655
Bunkyo-ku, Hongo, 7-3-1
03-3815-5411
kiyosuea-int@h.u-tokyo.ac.jp
1st name | Hiroyuki |
Middle name | |
Last name | Kiriyama |
The University of Tokyo Hospital
Cardiovascular Medicine
113-8655
Bunkyo-ku, Hongo, 7-3-1
03-3815-5411
kiriyaman0427@gmail.com
The university of Tokyo Hospital
The university of Tokyo Hospital
Other
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo,Intervention Research Ethics Committee
Bunkyo-ku hongo 7-3-1, Tokyo, Japan
03-5841-0818
ethics@m.u-tokyo.ac.jp
NO
2020 | Year | 02 | Month | 05 | Day |
Unpublished
No longer recruiting
2018 | Year | 12 | Month | 25 | Day |
2019 | Year | 01 | Month | 29 | Day |
2019 | Year | 02 | Month | 01 | Day |
2021 | Year | 12 | Month | 31 | Day |
2021 | Year | 12 | Month | 31 | Day |
None
2020 | Year | 02 | Month | 05 | Day |
2021 | Year | 08 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037570
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