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

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

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

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.

transradial coronary angiography, radial artery occlusion, coronary heart disease, Glidesheath Slender

The transradial procedure will be performed using the standard 6- French radial sheath (comparator sheath)

testing the efficacy and safety of the new transradial sheath in comparison to the standard 6 french sheath.

Includes: Radial artery occlusion, bleeding or hematoma, pseudoaneurysm, artery dissection, compartment syndrome of the forearm

Defined as ability to finish the angiogram/PCI via the intended access site, without the need to change access site.

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

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.

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.

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.