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

Coronary Heart Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02324764
Study type Interventional
Source Ottawa Heart Institute Research Corporation
Contact
Status Completed
Phase N/A
Start date December 2014
Completion date March 21, 2019
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