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

Information source: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Embolism and Thrombosis of the Radial Artery; Coronary Heart Disease

Intervention: Glidesheath Slender (Device); standard 6- French radial sheath (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Ottawa Heart Institute Research Corporation

Official(s) and/or principal investigator(s):
Aun-Yeong Chong, MRCP, MD, Principal Investigator, Affiliation: University of Ottawa Heart Institute Research Corporation

Overall contact:
Aun-Yeong Chong, MRCP, MD, Phone: 6137985555, Ext: 15128, Email: achong@ottawaheart.ca

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: Radial artery occlusion

Secondary outcome:

Vascular access site complications

Radial artery spasm

Procedure success

Sheath kinking

Painful sheath removal

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Aun-Yeong Chong, MRCP, MD, Phone: 6137985555, Ext: 15128, Email: achong@ottawaheart.ca

University of Ottawa Heart Institute, Ottawa, Ontario K1Y 4W7, Canada; Recruiting
Colleen Chilton, Phone: +1 613 7985555, Ext: 4646, Email: cchilton@ottawaheart.ca
Lyne Stuewe, Phone: +16137985555, Ext: 4646, Email: lstuewe@ottawaheart.ca
Additional Information

Related publications:

Kotowycz MA, Johnston KW, Ivanov J, Asif N, Almoghairi AM, Choudhury A, Nagy CD, Sibbald M, Chan W, Seidelin PH, Barolet AW, Overgaard CB, Džavík 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, Dzavík V. Radial artery patency after transradial catheterization. Circ Cardiovasc Interv. 2012 Feb 1;5(1):127-33. doi: 10.1161/CIRCINTERVENTIONS.111.965871. Review.

Starting date: December 2014
Last updated: August 4, 2015

Page last updated: August 20, 2015

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