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

December 12, 2021 updated by: Grigorios Tsigkas, University Hospital of Patras

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

371

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Achaia
      • Patras, Achaia, Greece, 26504
        • University Hospital of Patras

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of successful hemostasis at 30 minutes after sheath removal
Time Frame: 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
Time Frame: During the procedure
During the procedure
Pain associated with the procedure (visual analog scale, VAS)
Time Frame: During the procedure
0-10, 0: no pain, 10: worst pain possible
During the procedure
Rate of hematoma modified EASY class≥II
Time Frame: Up to 24 hours after hemostatic device removal
Up to 24 hours after hemostatic device removal
Rate of forearm radial artery occlusion
Time Frame: 7-10 days after the coronary angiography
7-10 days after the coronary angiography
Rate of distal radial artery occlusion
Time Frame: 7-10 days after the coronary angiography
7-10 days after the coronary angiography
Rate of fistula formation
Time Frame: 7-10 days after the coronary angiography
7-10 days after the coronary angiography
Rate of pseudoaneurysm formation
Time Frame: 7-10 days after the coronary angiography
7-10 days after the coronary angiography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Patras

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2021

Primary Completion (Actual)

November 25, 2021

Study Completion (Actual)

December 2, 2021

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 30, 2021

First Posted (Actual)

June 2, 2021

Study Record Updates

Last Update Posted (Actual)

December 14, 2021

Last Update Submitted That Met QC Criteria

December 12, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1762/22.01.21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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