Unique ID issued by UMIN | UMIN000002634 |
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Receipt number | R000002615 |
Scientific Title | Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET) |
Date of disclosure of the study information | 2009/11/01 |
Last modified on | 2021/02/20 10:22:58 |
Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET)
RESET
Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET)
RESET
Japan |
coronary artery disease
Cardiology |
Others
NO
To evaluate the efficacy and long-term safety of XIENCE drug-eluting stent
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Any TLR at 1 year
Death / MI at 3 years
Death / MI at 1 year and 2 years
Success rate for stent deployment
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Device,equipment |
XIENCE V stent implantation in 1600 patients
CYPHER SELECT+stent implantation in 1600 patients
Not applicable |
Not applicable |
Male and Female
The patients who will be recieved drug-eluting stent
The patients who refuse to participate in this study
3200
1st name | |
Middle name | |
Last name | KIMURA TAKESHI |
Kyoto University Hospital
Department of Cardiovascular Medicine
606-8507 54 Kawahara-cho Syogoin Sakyo-ku Kyoto City
075-751-3185
1st name | |
Middle name | |
Last name | TAMURA TOSHIHIRO |
Kyoto University Hospital
Department of Cardiovascular Medicine
606-8507 54 Kawahara-cho Syogoin Sakyo-ku Kyoto City
075-751-4255
ttamu@kuhp.kyoto-u.ac.jp
RESET trial
Abbott Vascular Japan, Co., Ltd.
Profit organization
Japan
nothing
nothing
NO
2009 | Year | 11 | Month | 01 | Day |
https://www.ahajournals.org/loi/circ/group/d2010.y2019
Published
https://www.ahajournals.org/loi/circ/group/d2010.y2019
3197
From February and July 2010, 3197 patients
were randomly assigned to receive either EES (1597 patients) or SES (1600 patients). At 1 year, the primary efficacy end point
of target-lesion revascularization occurred in 65 patients (4.3%) in the EES group and in 76 patients (5.0%) in the SES group,
demonstrating noninferiority of EES to SES (Pnoninferiority<0.0001, and Psuperiority<0.34). Cumulative incidence of definite
stent thrombosis was low and similar between the 2 groups (0.32% versus 0.38%, P<0.77).
2021 | Year | 02 | Month | 20 | Day |
All-comer trial
Randomization
death, ST, procedure related adverse events
TLR
death/MI
Completed
2009 | Year | 07 | Month | 27 | Day |
2009 | Year | 11 | Month | 18 | Day |
2010 | Year | 02 | Month | 01 | Day |
2014 | Year | 01 | Month | 01 | Day |
2009 | Year | 10 | Month | 16 | Day |
2021 | Year | 02 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002615
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