Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial

Not Applicable

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

• Registration Number: NCT02269449
• Lead Sponsor: NPO International TRI Network

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-10
• Study Start: 2014-10
• Study First Submitted: 2014-10-07
• Study First Submitted QC: 2014-10-16
• Last Update Submitted: 2014-10-16
• Study First Posted: 2014-10-21
• Last Update Posted: 2014-10-21
• Primary Completion: 2015-04
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1900

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5Fr contemporary sheath	5Fr sheath	TRI will be performed using a contemporary safety of 5Fr sheath.
Hemostasis with TR band	Hemostasis with TR band	Hemostasis is achieved by randomization of using TR band (TERUMO) Patent hemostasis.
Any hemostasis procedure	Any hemostasis procedure	Hemostasis is achieved by randomization of any hemostasis of each hospital's routine procedure.
6Fr Glidesheath Slender sheath	6Fr Glidesheath Slender sheath	TRI will be performed using a new 6Fr sheath (Glidesheath slender: GSS).

Primary Outcome Measures

Name	Time	Method
Radial artery occlusion	Day 1
Local bleeding from puncture site	Day 1

Secondary Outcome Measures

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