UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023058 |
|---|---|
| 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 |
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Basic information
Public title
RAP and BEAT International Clinical Trial (Radial Artery Patency and Bleeding, Effectiveness, Adverse evenT Trial)
Acronym
RAP and BEAT International Clinical Trial
Scientific Title
RAP and BEAT International Clinical Trial (Radial Artery Patency and Bleeding, Effectiveness, Adverse evenT Trial)
Scientific Title:Acronym
RAP and BEAT International Clinical Trial
Region
| Japan | North America | Europe |
Condition
Condition
Percutaneous Coronary Intervention
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
6Fr Glidesheath Slender sheath
TRI will be performed using a new 6Fr sheath (Glidesheath slender: GSS).
Interventions/Control_2
5Fr contemporary sheath
TRI will be performed using a contemporary safety of 5Fr sheath.
Interventions/Control_3
Hemostasis with TR band
Hemostasis is achieved by randomization of using TR band (TERUMO) Patent hemostasis.
Interventions/Control_4
Any hemostasis procedure
Hemostasis is achieved by randomization of any hemostasis of each hospital's routine procedure.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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
Target sample size
1900
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Saito M.D. |
Organization
Shonan Kamakura General Hospital
Division name
Cardiology and Cathlab
Zip code
Address
1370-1, Okamoto, Kamakura, Kanagawa, Japan
TEL
046746-1717
fightingradialist@tri-international.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Asou |
Organization
Shonan Kamakura General Hospital
Division name
Clinical research center
Zip code
Address
1370-1, Okamoto, Kamakura, Kanagawa, Japan
TEL
0467-46-1717
Homepage URL
keiko.asou@tokushukai.jp
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonan Kamakura General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 07 | Day |
Last modified on
| 2016 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023384
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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