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

University Hospital of Patras

Status: Completed

Conditions: Coronary Angiography; Radial Artery Occlusion; Arterial Access

Treatments: Device: GlideSheath Slender 5Fr arterial sheath; Device: Conventional 5Fr arterial sheath

Study type: Interventional

Funder types: Other

Identifiers

NCT04911218

1762/22.01.21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 371 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

371 participants in 2 patient groups

GlideSheath Slender 5Fr arterial sheath

Experimental group

Description:

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

Treatment:

Device: GlideSheath Slender 5Fr arterial sheath

Conventional 5Fr arterial sheath

Active Comparator group

Description:

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

Treatment:

Device: Conventional 5Fr arterial sheath