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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
400
testing the efficacy and safety of the new transradial sheath in comparison to the standard 6 french sheath.
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Radial artery occlusion
Evaluated clinically and by ultrasound
Time frame: 30 days
Vascular access site complications
Includes: Radial artery occlusion, bleeding or hematoma, pseudoaneurysm, artery dissection, compartment syndrome of the forearm
Time frame: up to 30 days
Radial artery spasm
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day
Procedure success
Defined as ability to finish the angiogram/PCI via the intended access site, without the need to change access site.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day
Sheath kinking
Major requiring sheath exchange or minor
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day
Painful sheath removal
Scored on a scale of 1-10 scoring system
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day
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