Coronary Heart Disease, Embolism and Thrombosis of the Radial Artery
Conditions
Keywords
transradial coronary angiography, radial artery occlusion, coronary heart disease, Glidesheath Slender
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.
Interventions
DEVICEGlidesheath Slender
testing the efficacy and safety of the new transradial sheath in comparison to the standard 6 french sheath.
DEVICEstandard 6- French radial sheath
Sponsors
Ottawa Heart Institute Research Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radial artery occlusion | 30 days | Evaluated clinically and by ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vascular access site complications | up to 30 days | Includes: Radial artery occlusion, bleeding or hematoma, pseudoaneurysm, artery dissection, compartment syndrome of the forearm |
| 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. |
| Sheath kinking | participants will be followed for the duration of hospital stay, an expected average of 1 day | Major requiring sheath exchange or minor |
| 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 |
Countries
Canada
Outcome results
None listed