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

NCT04911218 | Completed

• 1 other identifier: 1762/22.01.21
• Study Type: interventional
• Target: 371
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Access; Coronary Angiography; Radial Artery Occlusion

Keywords

arterial access; coronary angiography; radial access; distal radial access; radial artery occlusion

Outcome Measures

Primary Outcomes (1)

• Rate of successful hemostasis at 30 minutes after sheath removal

  At 30 minutes after sheath removal

Secondary Outcomes (7)

• Crossover rate to conventional radial access

  During the procedure

• Pain associated with the procedure (visual analog scale, VAS)

  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

Study Arms (2)

GlideSheath Slender 5Fr arterial sheath

EXPERIMENTAL

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

Device: GlideSheath Slender 5Fr arterial sheath

Conventional 5Fr arterial sheath

ACTIVE COMPARATOR

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

Device: Conventional 5Fr arterial sheath

Interventions

GlideSheath Slender 5Fr arterial sheath DEVICE

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

GlideSheath Slender 5Fr arterial sheath

Conventional 5Fr arterial sheath DEVICE

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

Conventional 5Fr arterial sheath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for coronary angiography
• Age\>18 years
• Informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

University Hospital of Patras

Pátrai, Achaia, 26504, Greece

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Cardiology

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 2, 2021
• Study Start: May 10, 2021
• Primary Completion: November 25, 2021
• Study Completion: December 2, 2021
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)