GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery

Study Overview
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Brief Summary
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Transradial approach has become the default arterial access for coronary angiography (CAG) and percutaneous coronary intervention (PCI), mainly due to lower incidence of bleeding compared to transfemoral access.1 However, TRA is not deprived of local access site complications such as radial artery occlusion (RAO), occurring in approximately 5.2% of patients, compartment syndrome, pseudoaneurysm, hematoma, and arteriovenous fistula. Recently, a novel approach has been proposed, the access through the distal radial artery (distal transradial access, dTRA), located in the anatomical snuffbox. Initial studies regarding the dRA have shown feasibility and benefits, including shorter hemostasis time, fewer local access site complications and potentially lower incidence of RAO. GlideSheath Slender is a novel sheath which has a hydrophilic coating and is made of a thinner material than traditional sheaths. As a result, the external diameter of the 5 Fr GlideSheath Slender sheath is 1 Fr lower compared with conventional arterial sheaths. The purpose of the present study was to investigate whether the use of the Slender sheath affects the time of hemostasis, sheath insertion time, crossover rate to conventional radial access, pain associated with the procedure and incidence of local access site complications (RAO, distal radial artery occlusion, fistula, hematoma) in patients undergoing diagnostic angiography through the distal radial artery.

Detailed Description
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Patients fulfilling the enrollment criteria will be randomized 1:1 to GlideSheath Slender versus conventional 5Fr arterial sheath for access through the distal radial artery (dTRA). In case an interventional procedure is required then the initial sheath will be exchanged to a larger sheath according to the circumstances of the case and the patient will not be included in the analysis. For randomized patients sheath insertion time, necessity for crossover to conventional radial access, pain associated with the procedure (visual pain scale) and occurrence of hematoma will be recorded. Follow-up ultrasound 7-10 days after the procedure for detection of RAO, distal radial artery occlusion and fistula formation will be performed.

Official Title
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Randomized Comparison of GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery (Anatomical Snuffbox)

Conditions
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Arterial Access, Coronary Angiography, Radial Artery Occlusion

Intervention / Treatment
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* Device: GlideSheath Slender 5Fr arterial sheath
* Device: Conventional 5Fr arterial sheath


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for coronary angiography Age>18 years Informed consent Exclusion Criteria: Non-palpable right radial artery Prior CABG STEMI Prior right transaradial intervention within the previous 2 months Hemodynamic instability Anatomical restrictions (fistula orthopaedic problems, etc)

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GlideSheath Slender 5Fr arterial sheath<br>Placement of GlideSheath Slender 5Fr arterial sheath for diagnostic angiography through the distal radial artery (anatomical snuffbox). | Device: GlideSheath Slender 5Fr arterial sheath<br>* Placement of GlideSheath Slender 5Fr arterial sheath for coronary angiography through the distal radial artery (anatomical snuffbox).<br>|
| Active Comparator: Conventional 5Fr arterial sheath<br>Placement of Conventional 5Fr arterial sheath arterial sheath for diagnostic angiography through the distal radial artery (anatomical snuffbox). | Device: Conventional 5Fr arterial sheath<br>* Placement of conventional 5Fr arterial sheath for coronary angiography through the distal radial artery (anatomical snuffbox).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful hemostasis at 30 minutes after sheath removal |  | At 30 minutes after sheath removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crossover rate to conventional radial access |  | During the procedure | 
| Pain associated with the procedure (visual analog scale, VAS) | 0-10, 0: no pain, 10: worst pain possible | During the procedure | 
| Rate of hematoma modified EASY class≥II |  | Up to 24 hours after hemostatic device removal | 
| Rate of forearm radial artery occlusion |  | 7-10 days after the coronary angiography | 
| Rate of distal radial artery occlusion |  | 7-10 days after the coronary angiography | 
| Rate of fistula formation |  | 7-10 days after the coronary angiography | 
| Rate of pseudoaneurysm formation |  | 7-10 days after the coronary angiography | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arterial access, coronary angiography, radial access, distal radial access, radial artery occlusion