UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	RAP and BEAT International Clinical Trial (Radial Artery Patency and Bleeding, Effectiveness, Adverse evenT Trial)
Title of the study (Brief title)	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	Shigeru Saito M.D.
Organization	Shonan Kamakura General Hospital
Division name	Cardiology and Cathlab
Address	1370-1, Okamoto, Kamakura, Kanagawa, Japan
TEL	046746-1717
Email	fightingradialist@tri-international.org

Public contact
Name of contact person	Keiko Asou
Organization	Shonan Kamakura General Hospital
Division name	Clinical research center
Address	1370-1, Okamoto, Kamakura, Kanagawa, Japan
TEL	0467-46-1717
Homepage URL
Email	keiko.asou@tokushukai.jp

Sponsor
Institute	Shonan Kamakura General Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023384