RAPandBEAT: Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial

• Sponsor: NPO International TRI Network (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02269449
• Collaborator: European Cardiovascular Research Center (Other), Duke Clinical Research Institute (Other)
• Enrollment: 1,900
• Arms: 4
• Duration (Months): 6

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Percutaneous Coronary Intervention	Device: 6Fr Glidesheath Slender sheath; Device: 5Fr sheath; Procedure: Hemostasis with TR band; Procedure: Any hemostasis procedure	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1900 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: RAP and BEAT Clinical Trial (Radial Artery Patency and Bleeding, Effectiveness, Adverse evenT Trial)
• Study Start Date: Oct 1, 2014
• Anticipated Primary Completion Date: Apr 1, 2015
• Anticipated Study Completion Date: Apr 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Radial artery occlusion [Day 1]

2. Local bleeding from puncture site [Day 1]

Secondary Outcome Measures

1. Procedure success rate [Day 1]

2. Vascular access site complication [Day 1]

3. Radial spasm during the index procedure [Day 1]

4. Total Procedure Time [Day 1]

5. Total Amount of Contrast Dye [Day 1]

6. Total Radiation Doses [Day 1]

7. Device failure for the assigned sheath introducer [Day 1]

8. Pain score [Day 1]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• NPO International TRI Network
• European Cardiovascular Research Center
• Duke Clinical Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NPO International TRI Network
• ClinicalTrials.gov Identifier: NCT02269449
• Other Study ID Numbers: TRI20140920
• First Posted: Oct 21, 2014
• Last Update Posted: Oct 21, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by NPO International TRI Network: transradial intervention; radial artery
• Additional relevant MeSH terms: Hemorrhage; Hemostatics

Study Results

No Results Posted as of Oct 21, 2014