Unique ID issued by UMIN | UMIN000023058 |
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Receipt number | R000023384 |
Scientific Title | RAP and BEAT International Clinical Trial (Radial Artery Patency and Bleeding, Effectiveness, Adverse evenT Trial) |
Date of disclosure of the study information | 2016/07/08 |
Last modified on | 2016/08/04 08:58:37 |
RAP and BEAT International Clinical Trial (Radial Artery Patency and Bleeding, Effectiveness, Adverse evenT Trial)
RAP and BEAT International Clinical Trial
RAP and BEAT International Clinical Trial (Radial Artery Patency and Bleeding, Effectiveness, Adverse evenT Trial)
RAP and BEAT International Clinical Trial
Japan | North America | Europe |
Percutaneous Coronary Intervention
Cardiology |
Others
NO
The objective of this study is to demonstrate the safety and efficacy of the new 6Fr sheath (Glidesheath slender 6Fr; GSS 6Fr) compared with the contemporary 5Fr sheath (standard of care 5Fr; SOC 5Fr) both from Terumo; Tokyo, Japan.
Safety,Efficacy
Composite of freedom from radial artery occlusion (RAO) and local bleeding from the puncture site at the time of discharge or the next day, the earlier of the two.
Procedure success rate at the index procedure,Vascular access site complication,Radial spasm during the index procedure,Total Procedure Time
,Total Amount of Contrast Dye,Fluoroscope time,Procedure failure due to the assigned sheath,Pain score
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
4
Prevention
Device,equipment |
6Fr Glidesheath Slender sheath
TRI will be performed using a new 6Fr sheath (Glidesheath slender: GSS).
5Fr contemporary sheath
TRI will be performed using a contemporary safety of 5Fr sheath.
Hemostasis with TR band
Hemostasis is achieved by randomization of using TR band (TERUMO) Patent hemostasis.
Any hemostasis procedure
Hemostasis is achieved by randomization of any hemostasis of each hospital's routine procedure.
18 | years-old | <= |
Not applicable |
Male and Female
1.Patient must be at least 18 years of age.
2.Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives and he or his legally authorized representative provides written informed consent prior to the randomization, as approved by the appropriate IRB.
3.Patient who is going to have a coronary artery angiography or subsequent PCI.
4.Patient must agree to undergo all protocol-required in hospital follow-up examinations.
5.Patient who are suitable for radial access.
1.Patient who has a serious medical illness that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
2.Hemodialysis patient
3.STEMI
1900
1st name | |
Middle name | |
Last name | Shigeru Saito M.D. |
Shonan Kamakura General Hospital
Cardiology and Cathlab
1370-1, Okamoto, Kamakura, Kanagawa, Japan
046746-1717
fightingradialist@tri-international.org
1st name | |
Middle name | |
Last name | Keiko Asou |
Shonan Kamakura General Hospital
Clinical research center
1370-1, Okamoto, Kamakura, Kanagawa, Japan
0467-46-1717
keiko.asou@tokushukai.jp
Shonan Kamakura General Hospital
Shonan Kamakura General Hospital
Other
NO
2016 | Year | 07 | Month | 08 | Day |
Unpublished
Completed
2014 | Year | 09 | Month | 17 | Day |
2014 | Year | 10 | Month | 28 | Day |
2016 | Year | 06 | Month | 30 | Day |
2016 | Year | 06 | Month | 30 | Day |
2016 | Year | 12 | Month | 31 | Day |
2016 | Year | 12 | Month | 31 | Day |
2016 | Year | 07 | Month | 07 | Day |
2016 | Year | 08 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023384
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