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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glidesheath Slender | Experimental | The transradial procedure will be performed using the glidesheath slender (studied sheath) |
|
| Standard sheath | Active Comparator | The transradial procedure will be performed using the standard 6- French radial sheath (comparator sheath) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glidesheath Slender | Device | testing the efficacy and safety of the new transradial sheath in comparison to the standard 6 french sheath. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radial artery occlusion | Evaluated clinically and by ultrasound | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular access site complications | Includes: Radial artery occlusion, bleeding or hematoma, pseudoaneurysm, artery dissection, compartment syndrome of the forearm | up to 30 days |
| Radial artery spasm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aun-Yeong Chong, MRCP, MD | University of Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24461923 | Background | Kotowycz MA, Johnston KW, Ivanov J, Asif N, Almoghairi AM, Choudhury A, Nagy CD, Sibbald M, Chan W, Seidelin PH, Barolet AW, Overgaard CB, Dzavik V. Predictors of radial artery size in patients undergoing cardiac catheterization: insights from the Good Radial Artery Size Prediction (GRASP) study. Can J Cardiol. 2014 Feb;30(2):211-6. doi: 10.1016/j.cjca.2013.11.021. Epub 2013 Nov 23. | |
| 24285594 |
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| standard 6- French radial sheath | Device |
|
| 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. | participants will be followed for the duration of hospital stay, an expected average of 1 day |
| Sheath kinking | Major requiring sheath exchange or minor | 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 | participants will be followed for the duration of hospital stay, an expected average of 1 day |
| Background |
| Aminian A, Dolatabadi D, Lefebvre P, Zimmerman R, Brunner P, Michalakis G, Lalmand J. Initial experience with the Glidesheath Slender for transradial coronary angiography and intervention: a feasibility study with prospective radial ultrasound follow-up. Catheter Cardiovasc Interv. 2014 Sep 1;84(3):436-42. doi: 10.1002/ccd.25232. Epub 2013 Nov 6. |
| 22338002 | Background | Kotowycz MA, Dzavik V. Radial artery patency after transradial catheterization. Circ Cardiovasc Interv. 2012 Feb 1;5(1):127-33. doi: 10.1161/CIRCINTERVENTIONS.111.965871. No abstract available. |
| ID | Term |
|---|---|
| D004617 | Embolism |
| D003327 | Coronary Disease |
| D001157 | Arterial Occlusive Diseases |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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