Unique ID issued by UMIN | UMIN000033534 |
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Receipt number | R000038237 |
Scientific Title | Study to examine correlation between predictive value and post PCI value of iFR, RFR and dPR |
Date of disclosure of the study information | 2018/08/01 |
Last modified on | 2020/11/10 12:50:16 |
Study to examine correlation between predictive value and post PCI value of iFR, RFR and dPR
Correlation between predictive value and post PCI value of iFR, RFR and dPR
Study to examine correlation between predictive value and post PCI value of iFR, RFR and dPR
Correlation between predictive value and post PCI value of iFR, RFR and dPR
Japan |
Stable coronary diseases
Cardiology |
Others
NO
Evaluation of the difference and correlation between predictive value of iFR, RFR and dPR; average predictive value and post PCI value of iFR, RFR and dPR
Efficacy
Confirmatory
Pragmatic
Not applicable
Evaluation of the difference and correlation between predictive value of iFR, RFR and dPR; average predictive value and post PCI value of iFR, RFR and dPR
1) Evaluate separately by Type A, B, C (tandem lesion, diffuse lesion)
2) Comparison of measurement time of RFR and dPR compared to iFR
3) Drift of each pressure wire
4) Proportion of 0.9 or more for post iFR, post RFR and post dPR; whether additional treatment was done
5) Whether post FFR achieves 0.8 or more. Whether additional treatment was done
6) Evaluation of plaque properties with IVUS (Terumo,Boston,NIPRO) of fiber component, lipid component, calcification. In particular, the predictive value when highly calcified at least 270 degrees of calcification is observed is not significantly different from the post PCI value.
7) Number of stents used and stent length
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
3
Diagnosis
Device,equipment |
The group (iFR group) which measured predictive value and post PCI value by iFR
The group (RFR group) which measured predictive value and post PCI value by RFR
The group (dPR group) which measured predictive value and post PCI value by dPR
20 | years-old | <= |
100 | years-old | >= |
Male and Female
Patient who is scheduled to undergo CAG and iFR, RFR or dPR is positive (0.89 or less) and PCI is planned
Bypass patients. ATP, nicorandil, papaverin contraindicated patients. STEMI. TIMI flow grade <3.90% < stenosis
150
1st name | Hitoshi |
Middle name | |
Last name | Matsuo |
Gifu Heart Center
Department of Cardiovascular Medicine
500-8384
4-14-4 Yabuta-Minami, Gifu, Japan
058-277-2277
matsuo@heart-center.or.jp
1st name | Hiroyuki |
Middle name | |
Last name | Omori |
Gifu Heart Center
Department of Cardiovascular Medicine
500-8384
4-14-4 Yabuta-Minami, Gifu, Japan
058-277-2277
omori@heart-center.or.jp
Gifu Heart Center
NA
Other
Toyohashi Heart Center. Nagoya Heart Center
Gifu Heart Center
4-14-4 Yabuta-Minami, Gifu
058-277-2277
inada@heart-center.or.jp
NO
岐阜ハートセンター(岐阜県)、豊橋ハートセンター(愛知県)、名古屋ハートセンター(愛知県)
2018 | Year | 08 | Month | 01 | Day |
https://www.jacc.org/doi/10.1016/j.jcin.2020.06.060?fbclid=IwAR2u6J0ZyPl3Llb5Kq9wxU91p98hEeImBYlnm-W
Published
https://www.jacc.org/doi/10.1016/j.jcin.2020.06.060?fbclid=IwAR2u6J0ZyPl3Llb5Kq9wxU91p98hEeImBYlnm-W
150
The pre-PCI predicted NHPRs had strong correlations with actual post-PCI NHPRs. The agreements be-tween pre-PCI predicted and actual post-PCI NHPRs were 0.02 for iFR, 0.01 for RFR, 0.02 for dPR, respectively.The number and the total length of treated lesions were lower in the NHPR pullback- than in the angiography-guided strategy. Actual post-PCI NHPRs had a poor correlation to the difference between angiography- and NHPR pullback-guided strategies
2020 | Year | 11 | Month | 10 | Day |
The mean age of the patients was 71 years, and 108 (77%) were men. The lesions were located most frequently in the left anterior descending artery (100 vessels (66.7%)). The NHPR groups had no significant differences in patient and lesion characteristics.
Patients with stable coronary artery disease which were defined as having angiographically 40%-90% stenosis and NHPRs less than or equal 0.89 in major epicardial vessels, were included.Vessels were randomly assigned, in a 1:1:1 ratio, to receive iFR, RFR, or dPR pullback, without stratification factors.
The procedures were performed successfully in all cases without any adverse events or complications.
The primary endpoint was to assess the relevance between pre-PCI predicted and actual post-PCI NHPRs. The secondary endpoints were to assess the reduction of the number and the total length of treated lesions based on the NHPRs pullback-guided PCI compared with angiography-guided PCI, in terms of procedural benefits.
Completed
2018 | Year | 07 | Month | 24 | Day |
2018 | Year | 07 | Month | 25 | Day |
2018 | Year | 08 | Month | 01 | Day |
2019 | Year | 12 | Month | 31 | Day |
2019 | Year | 12 | Month | 31 | Day |
2019 | Year | 12 | Month | 31 | Day |
2019 | Year | 12 | Month | 31 | Day |
2018 | Year | 07 | Month | 27 | Day |
2020 | Year | 11 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038237
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