Clinical trial NCT02324764: Use of Glidesheath Slender to Reduce Radial Artery Occlusion and Vascular Access Site Complications Following Transradial Coronary Angiography
Official title: Use of Glidesheath Slender to Reduce Radial Artery Occlusion and Vascular Access Site Complications Following Transradial Coronary Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embolism and Thrombosis of the Radial Artery
Coronary Heart Disease
Keywords: transradial coronary angiography
radial artery occlusion
coronary heart disease
Glidesheath Slender
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Radial artery occlusion
timeFrame: 30 days
Secondary outcomes:
measure: Vascular access site complications
timeFrame: up to 30 days
measure: Radial artery spasm
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: Procedure success
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: Sheath kinking
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: Painful sheath removal
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 day
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: University of Ottawa Heart Institute Research Corporation
name: Aun-Yeong Chong, MRCP, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.