NCT02269449

Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,900 (estimated)
• Sponsor: NPO International TRI Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
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.
DEVICE	5Fr sheath	5Fr Hydrophilic coating sheath from Terumo.
PROCEDURE	Hemostasis with TR band	Hemostasis is achieved using TR band (TERUMO) Patent hemostasis.
PROCEDURE	Any hemostasis procedure	Hemostasis is achieved by any hemostasis of each hospital's routine procedure.

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-10-21
• Last updated: 2014-10-21