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 complicationsRadial 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
|