Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial

Study Overview
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Brief Summary
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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).

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

Conditions
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Percutaneous Coronary Intervention

Intervention / Treatment
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* Device: 6Fr Glidesheath Slender sheath
* Device: 5Fr sheath
* Procedure: Hemostasis with TR band
* Procedure: Any hemostasis procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transradial intervention, radial artery