Use of Glidesheath Slender to Reduce Radial Artery Occlusion Following 7 French Transradial Coronary Intervention

Study Overview
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Brief Summary
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The objective of this study is to determine the rate of early radial artery occlusion following 7-French(7-Fr) transradial coronary intervention using a new Terumo (Tokyo, Japan) Glidesheath Slender, in comparison with the currently used 7-Fr radial sheath.

Detailed Description
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Based on previously reported studies the rates of radial artery occlusion using a standard 7-Fr sheath is around 12%, compared to the previous studies of the Glidesheath Slender (see reference in the citations), the rate of radial artery occlusion was reported less than 5%. To prove Slender sheaths are superior to traditional ones, the sample size was estimated according to this, the class I error (α) is set as 0.05 on both sides, and the test efficiency (β) is set as 80%, then at least 248 patients are needed in each group. This study will be a prospective randomized, single-blinded (patient-blinded) study, comparing the rate of radial artery occlusion between the 7-Fr Glidesheath Slender (Terumo, Japan) and the standard 7-Fr radial sheath (cordis, USA) in patients undergoing complex transradial coronary intervention. The study will enroll patients who will undergo elective complex percutaneous coronary intervention (PCI) via 7-Fr transradial approach at Fuwai Hospital National Center for Cardiovascular Diseases. 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 7-Fr Terumo Glidesheath Slender versus the currently used 7-Fr sheath. The standard angiogram/ PCI will be performed as per usual practice. Following the PCI, clinical vascular assessment as well as an ultrasound will be performed prior to discharge.

Official Title
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Use of Glidesheath Slender to Reduce Radial Artery Occlusion Following 7 French Transradial Coronary Intervention

Conditions
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Radial Artery Occlusion, Coronary Artery Disease

Intervention / Treatment
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* Device: 7-Fr Glidesheath Slender
* Device: Cordis 7-Fr radial sheath


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing coronary PCI via 7-Fr transradial approach Informed consent the patency of radial artery confirmed by ultrasound Exclusion Criteria: The abnormal of radial artery confirmed by ultrasound 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: 85 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 7-Fr glidesheath slender (studied sheath) | Device: 7-Fr Glidesheath Slender<br>* The 7 Fr Glidesheath Slender is a recently developed thin-walled radial sheath. It combines an ID of 2.46 mm, with an OD of 2.79 mm, representing thereby the thinnest 7 Fr sheath currently available on the market<br>* Other names: Glidesheath Slender, Terumo, Tokyo, Japan;|
| Active Comparator: Standard sheath<br>The transradial procedure will be performed using the standard 7- French radial sheath (comparator sheath) | Device: Cordis 7-Fr radial sheath<br>* Avanti+ Catheter Sheath Introducer, Cordis, USA, outer diameter: 3.02 mm<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 | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular access site complications | Includes: bleeding or hematoma, pseudoaneurysm, artery dissection, arteriovenous fistula, compartment syndrome of the forearm | 24 hours | 
| Radial artery spasm | Radial artery spasm | 24 hours | 
| Procedure success | completion of the planned procedure through the initially selected radial access route | 24 hours | 
| The degree of pain at the puncture site | Scored on a scale of 1-10 scoring system | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radial artery occlusion, 7-Fr radial sheath, Transradial Coronary Intervention