Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial (RAPandBEAT)

NPO International TRI Network

Status: Unknown

Conditions: Percutaneous Coronary Intervention

Treatments: Procedure: Hemostasis with TR band; Procedure: Any hemostasis procedure; Device: 5Fr sheath; Device: 6Fr Glidesheath Slender sheath

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02269449

TRI20140920

Details and patient eligibility

About

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).

Enrollment: 1,900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,900 participants in 4 patient groups

6Fr Glidesheath Slender sheath

Experimental group

Description:

TRI will be performed using a new 6Fr sheath (Glidesheath slender: GSS).

Treatment:

Device: 6Fr Glidesheath Slender sheath

5Fr contemporary sheath

Active Comparator group

Description:

TRI will be performed using a contemporary safety of 5Fr sheath.

Treatment:

Device: 5Fr sheath

Hemostasis with TR band

Experimental group

Description:

Hemostasis is achieved by randomization of using TR band (TERUMO) Patent hemostasis.

Treatment:

Procedure: Hemostasis with TR band

Any hemostasis procedure

Active Comparator group

Description:

Hemostasis is achieved by randomization of any hemostasis of each hospital's routine procedure.

Treatment:

Procedure: Any hemostasis procedure