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

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

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).

Study Overview

• Status: Unknown
• Conditions: Percutaneous Coronary Intervention
• Intervention / Treatment: Device: 6Fr Glidesheath Slender sheath; Device: 5Fr sheath; Procedure: Hemostasis with TR band; Procedure: Any hemostasis procedure

• Study Type: Interventional
• Enrollment (Anticipated): 1900
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 6Fr Glidesheath Slender sheath; TRI will be performed using a new 6Fr sheath (Glidesheath slender: GSS).	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.
Active Comparator: 5Fr contemporary sheath; TRI will be performed using a contemporary safety of 5Fr sheath.	Device: 5Fr sheath; 5Fr Hydrophilic coating sheath from Terumo.
Experimental: Hemostasis with TR band; Hemostasis is achieved by randomization of using TR band (TERUMO) Patent hemostasis.	Procedure: Hemostasis with TR band; Hemostasis is achieved using TR band (TERUMO) Patent hemostasis.
Active Comparator: Any hemostasis procedure; Hemostasis is achieved by randomization of any hemostasis of each hospital's routine procedure.	Procedure: Any hemostasis procedure; Hemostasis is achieved by any hemostasis of each hospital's routine procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Radial artery occlusion	Day 1
Local bleeding from puncture site	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Procedure success rate	Day 1
Vascular access site complication	Day 1
Radial spasm during the index procedure	Day 1
Total Procedure Time	Day 1
Total Amount of Contrast Dye	Day 1
Total Radiation Doses	Day 1
Device failure for the assigned sheath introducer	Day 1
Pain score	Day 1

Collaborators and Investigators

• Sponsor: NPO International TRI Network
• Collaborators: Duke Clinical Research Institute; European Cardiovascular Research Center

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): April 1, 2015

Study Registration Dates

• First Submitted: October 7, 2014
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (Estimate): October 21, 2014

Study Record Updates

• Last Update Posted (Estimate): October 21, 2014
• Last Update Submitted That Met QC Criteria: October 16, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: radial artery; transradial intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Coagulants; Hemostatics
• Other Study ID Numbers: TRI20140920