Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial

Percutaneous Coronary Intervention Clinical Trial

— RAPandBEAT  

Official title:

RAP and BEAT Clinical Trial (Radial Artery Patency and Bleeding, Effectiveness, Adverse evenT Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02269449
• Other study ID #: TRI20140920
• Status: Not yet recruiting
• Phase: N/A
• First received: October 7, 2014
• Last updated: October 16, 2014
• Start date: October 2014
• Est. completion date: April 2015

Study information

• Verified date: October 2014
• Source: NPO International TRI Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objectives of this study are to demonstrate the safety and efficacy of the new 6Fr sheath (Glidesheath slender; Terumo, Tokyo,Japan ; GSS) compared with the contemporary 5Fr sheath (Hydrophilic coating sheath from Terumo; Tokyo, Japan (standard of care ; SOC).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1900
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

• Patient who is expected to diagnose by coronary artery angiography or followed by PCI.

• Patient must agree to undergo all protocol-required follow-up examinations.

• Patient who can accept radial access.

Exclusion Criteria:

• Patient has other medical illness (e.g., cancer or congestive heart failure) 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).

• Hemodialysis patient

• STEMI

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

Device:
• 6Fr Glidesheath Slender sheath
6Fr sheath (Glidesheath slender: GSS), which is characterized with the same inner lumen diameter with contemporary 6Fr sheath as well as the sheath outer diameter similar with contemporary 5Fr sheath.
• 5Fr sheath
5Fr Hydrophilic coating sheath from Terumo.

Procedure:
• Hemostasis with TR band
Hemostasis is achieved using TR band (TERUMO) Patent hemostasis.
• Any hemostasis procedure
Hemostasis is achieved by any hemostasis of each hospital's routine procedure.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
NPO International TRI Network	Duke Clinical Research Institute, European Cardiovascular Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radial artery occlusion		Day 1	No
Primary	Local bleeding from puncture site		Day 1	Yes
Secondary	Procedure success rate		Day 1	No
Secondary	Vascular access site complication		Day 1	Yes
Secondary	Radial spasm during the index procedure		Day 1	Yes
Secondary	Total Procedure Time		Day 1	No
Secondary	Total Amount of Contrast Dye		Day 1	No
Secondary	Total Radiation Doses		Day 1	No
Secondary	Device failure for the assigned sheath introducer		Day 1	No
Secondary	Pain score		Day 1	Yes