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

NCT ID: NCT04911218

Last Updated: 2021-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 371 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-10
• Study Completion Date: 2021-12-02

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.

Conditions

Arterial Access; Coronary Angiography; Radial Artery Occlusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

GlideSheath Slender 5Fr arterial sheath

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

Group Type: EXPERIMENTAL

GlideSheath Slender 5Fr arterial sheath

Intervention Type: DEVICE

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

Conventional 5Fr arterial sheath

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

Group Type: ACTIVE_COMPARATOR

Conventional 5Fr arterial sheath

Intervention Type: DEVICE

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

Interventions

GlideSheath Slender 5Fr arterial sheath

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

Intervention Type: DEVICE

Conventional 5Fr arterial sheath

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Patras

OTHER

Sponsor Role: lead

Responsible Party

Grigorios Tsigkas

Assistant Professor of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of Patras

Pátrai, Achaia, Greece

Countries

Greece

Other Identifiers

1762/22.01.21

Identifier Type: -

Identifier Source: org_study_id