NCT02324764

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Embolism and Thrombosis of the Radial Artery
• Coronary Heart Disease

Interventions

Type	Name	Description
DEVICE	Glidesheath Slender	testing the efficacy and safety of the new transradial sheath in comparison to the standard 6 french sheath.
DEVICE	standard 6- French radial sheath

Timeline

• Start date: 2014-12-01
• Primary completion: 2019-03-01
• Completion: 2019-03-21
• First posted: 2014-12-24
• Last updated: 2022-01-28

Locations

1 site across 1 country: Canada