GlideSheath Slender® Versus Conventional 6 French Arterial Sheath: Impact on the Distal Radial Artery Occlusion (SMART)

Study Overview
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Brief Summary
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Compared with conventional artery sheath (TERUMO, Introducer II ), GlideSheath Slender® has more smaller outer-side diameter. The investigators suspected that use of the GlideSheath Slender® can reduce the incidence of distal radial artery occlusion in cardiovascular intervention via dTRA approach.

Detailed Description
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Distal transradial artery (dTRA) approach has emerged as a new approach in cardiovascular intervention in recent years. Compared to the conventional radial artery (CRA) approach, the dTRA approach dramatically reduced the risk of radial artery occlusion (RAO). In recent years, the incidence of distal radial artery occlusion (dRAO) after dTRA intervention has been reported in the literature, ranged from 0.12% to 5.2%. Outside diameter of artery sheath may affect the incidence of dRAO. Retrospective study reported that an artery/ sheath ratio > 1.0 was least damaging to the vessel during coronary intervention via dTRA. Compared with conventional artery sheath (TERUMO, Introducer II ), 6 French GlideSheath Slender® has more smaller outer-side diameter (2.46mm vs. 2.62mm). The investigators suspected that use of the GlideSheath Slender can reduce the incidence of dRAO in cardiovascular intervention via dTRA approach.

Official Title
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GlideSheath Slender® Versus Conventional 6 French Arterial Sheath: Impact on the Incidence of Distal Radial Artery Occlusion in Cardiovascular Intervention Via Distal Radial Artery (SMART)

Conditions
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Coronary Artery Disease, Cardiovascular Diseases

Intervention / Treatment
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* Device: GlideSheath Slender® and conventional arterial sheath
* Device: Conventional arterial sheath


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Palpable distal radial and conventional radial artery Exclusion Criteria: Age ≥ 90years Height≥ 185cm ST-segment elevation myocardial infarction or Cardiogenic shock Contraindications to puncture at the puncture site Diameter of DRA less than 1.5mm or RAO

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Interventional Model Description: GlideSheath Slender® group Conventional Sheath group (TERUMO, Introducer II )
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GlideSheath Slender®<br>Placement of 6 French GlideSheath Slender® for cardiovascular intervention via distal radial artery | Device: GlideSheath Slender® and conventional arterial sheath<br>* Using the GlideSheath Slender® with the outside diameter 2.46mm<br>|
| Active Comparator: Conventional Sheath<br>Placement of 6 French conventional Sheath (TERUMO, Introducer II ) for cardiovascular intervention via distal radial artery | Device: Conventional arterial sheath<br>* Placement of 6 French conventional Sheath (TERUMO, Introducer II )<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of distal radial artery occlusion | The rate of distal radial artery occlusion is evaluated by ultrasound | 24 hours after the coronary angiography or intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of radial artery occlusion | The rate of radial artery occlusion is evaluated by ultrasound | 24 hours after the coronary angiography or intervention | 
| Pain during the placement of the sheath | Visual analog scale is used to evaluate the pain during the placement of the sheath, which ranges from 0-10, and 0 meas no pain | 24 hours after the coronary angiography or intervention | 
| Radial artery dissection | The incidence of dissection of the radial artery is evaluated by ultrasound | 24 hours after the coronary angiography or intervention | 
| Time of hemostasis | The time from the compress to hemostasis | 24 hours after the coronary angiography or intervention | 
| Haematoma | The incidence of haematoma is evaluated by Early Discharge After Transradial Stenting of Coronary Arteries Study criteria | 24 hours after the coronary angiography or intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distal radial artery, distal radial artery occlusion, cardiovascular intervention