Use of Glidesheath Slender to Reduce Radial Artery Occlusion and Vascular Access Site Complications Following Transradial Coronary Angiography

Not Applicable

Completed

• Conditions: Embolism and Thrombosis of the Radial Artery; Coronary Heart Disease

• Registration Number: NCT02324764
• Lead Sponsor: Ottawa Heart Institute Research Corporation

Brief Summary

The objective of this study is to determine the rate of radial artery occlusion and vascular access site complications following transradial angiogram using a new Terumo (Tokyo, Japan) Glidesheath Slender, in comparison with the currently used 6 French (6 Fr.) radial sheath.

Detailed Description

Based on previously reported studies the rates of radial artery occlusion using a standard 6 Fr. sheath is around 5-10%, compared to the single feasibility study of the Glidesheath Slender by Aminian et al (see reference in the citations), the rate of radial artery occlusion was reported 0.88%.

This study will be a prospective randomized, single-blinded (patient-blinded) study, comparing the rate of radial artery occlusion and vascular access site complications between the Glidesheath Slender (Terumo, Tokyo, Japan) and the standard 6 Fr. radial sheath in patients undergoing transradial coronary catheterization.

* The study will enroll patients who will undergo elective or emergency coronary angiography and/or percutaneous coronary intervention (PCI) via transradial approach at the University of Ottawa Heart Institute.

* A baseline clinical vascular \& ultrasound assessment will be performed prior to the procedure to document patency of the radial artery.

* Patients will be randomized in 1:1 fashion to either receive the Terumo Glidesheath Slender versus the currently used 6 Fr. sheath.

* The standard angiogram/ PCI will be performed as per usual practice.

* Following the angiogram, clinical vascular assessment as well as an ultrasound will be performed prior to discharge.

* At 30 days follow up the patient will come back for clinical and ultrasound assessment of radial artery patency and access site vascular complications.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-24
• Primary Completion: 2019-03
• Study Completion: 2019-03-21
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients undergoing coronary angiography and/or PCI via transradial approach
• Informed consent
• Documented normal Allen's test

Exclusion Criteria

• Patient who had a previous angiogram using the same radial artery
• Abnormal Allen's test
• Previous failed radial access.
• Known bleeding disorder or hypercoagulable condition
• Cardiogenic shock

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Radial artery occlusion	30 days	Evaluated clinically and by ultrasound

Secondary Outcome Measures

Name	Time	Method
Vascular access site complications	up to 30 days	Includes: Radial artery occlusion, bleeding or hematoma, pseudoaneurysm, artery dissection, compartment syndrome of the forearm
Painful sheath removal	participants will be followed for the duration of hospital stay, an expected average of 1 day	Scored on a scale of 1-10 scoring system
Sheath kinking	participants will be followed for the duration of hospital stay, an expected average of 1 day	Major requiring sheath exchange or minor
Radial artery spasm	participants will be followed for the duration of hospital stay, an expected average of 1 day
Procedure success	participants will be followed for the duration of hospital stay, an expected average of 1 day	Defined as ability to finish the angiogram/PCI via the intended access site, without the need to change access site.

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada