Use of Glidesheath Slender to Reduce Radial Artery Occlusion and Vascular Access Site Complications Following Transradial Coronary Angiography

Study Overview
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Brief Summary
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The objective of this study is to determine the rate of radial artery occlusion and vascular access site complications following transradial angiogram using a new Terumo (Tokyo, Japan) Glidesheath Slender, in comparison with the currently used 6 French (6 Fr.) radial sheath.

Detailed Description
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Based on previously reported studies the rates of radial artery occlusion using a standard 6 Fr. sheath is around 5-10%, compared to the single feasibility study of the Glidesheath Slender by Aminian et al (see reference in the citations), the rate of radial artery occlusion was reported 0.88%. This study will be a prospective randomized, single-blinded (patient-blinded) study, comparing the rate of radial artery occlusion and vascular access site complications between the Glidesheath Slender (Terumo, Tokyo, Japan) and the standard 6 Fr. radial sheath in patients undergoing transradial coronary catheterization. The study will enroll patients who will undergo elective or emergency coronary angiography and/or percutaneous coronary intervention (PCI) via transradial approach at the University of Ottawa Heart Institute. A baseline clinical vascular & ultrasound assessment will be performed prior to the procedure to document patency of the radial artery. Patients will be randomized in 1:1 fashion to either receive the Terumo Glidesheath Slender versus the currently used 6 Fr. sheath. The standard angiogram/ PCI will be performed as per usual practice. Following the angiogram, clinical vascular assessment as well as an ultrasound will be performed prior to discharge. At 30 days follow up the patient will come back for clinical and ultrasound assessment of radial artery patency and access site vascular complications.

Official Title
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Use of Glidesheath Slender to Reduce Radial Artery Occlusion and Vascular Access Site Complications Following Transradial Coronary Angiography

Conditions
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Embolism and Thrombosis of the Radial Artery, Coronary Heart Disease

Intervention / Treatment
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* Device: Glidesheath Slender
* Device: standard 6- French radial sheath


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing coronary angiography and/or PCI via transradial approach Informed consent Documented normal Allen's test Exclusion Criteria: Patient who had a previous angiogram using the same radial artery Abnormal Allen's test Previous failed radial access. Known bleeding disorder or hypercoagulable condition Cardiogenic shock

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glidesheath Slender<br>The transradial procedure will be performed using the glidesheath slender (studied sheath) | Device: Glidesheath Slender<br>* testing the efficacy and safety of the new transradial sheath in comparison to the standard 6 french sheath.<br>* Other names: Glidesheath Slender, Terumo, Tokyo, Japan;|
| Active Comparator: Standard sheath<br>The transradial procedure will be performed using the standard 6- French radial sheath (comparator sheath) | Device: standard 6- French radial sheath<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial artery occlusion | Evaluated clinically and by ultrasound | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular access site complications | Includes: Radial artery occlusion, bleeding or hematoma, pseudoaneurysm, artery dissection, compartment syndrome of the forearm | up to 30 days | 
| Radial artery spasm |  | participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| Procedure success | Defined as ability to finish the angiogram/PCI via the intended access site, without the need to change access site. | participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| Sheath kinking | Major requiring sheath exchange or minor | participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| Painful sheath removal | Scored on a scale of 1-10 scoring system | participants will be followed for the duration of hospital stay, an expected average of 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transradial coronary angiography, radial artery occlusion, coronary heart disease, Glidesheath Slender