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

Not Applicable

Completed

• Conditions: Coronary Angiography; Radial Artery Occlusion; Arterial Access
• Interventions: Device: GlideSheath Slender 5Fr arterial sheath; Device: Conventional 5Fr arterial sheath

• Registration Number: NCT04911218
• Lead Sponsor: University Hospital of Patras

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-05-10
• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-30
• Study First Posted: 2021-06-02
• Primary Completion: 2021-11-25
• Status Verified: 2021-12
• Study Completion: 2021-12-02
• Last Update Submitted: 2021-12-12
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 371

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GlideSheath Slender 5Fr arterial sheath	GlideSheath Slender 5Fr arterial sheath	Placement of GlideSheath Slender 5Fr arterial sheath for diagnostic angiography through the distal radial artery (anatomical snuffbox).
Conventional 5Fr arterial sheath	Conventional 5Fr arterial sheath	Placement of Conventional 5Fr arterial sheath arterial sheath for diagnostic angiography through the distal radial artery (anatomical snuffbox).

Primary Outcome Measures

Name	Time	Method
Rate of successful hemostasis at 30 minutes after sheath removal	At 30 minutes after sheath removal

Secondary Outcome Measures

Name	Time	Method
Rate of pseudoaneurysm formation	7-10 days after the coronary angiography
Crossover rate to conventional radial access	During the procedure
Pain associated with the procedure (visual analog scale, VAS)	During the procedure	0-10, 0: no pain, 10: worst pain possible
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 fistula formation	7-10 days after the coronary angiography
Rate of distal radial artery occlusion	7-10 days after the coronary angiography

Trial Locations

Locations (1)

University Hospital of Patras; 🇬🇷 Patras, Achaia, Greece