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

Coronary Heart Disease Clinical Trial

— CAPITAL-PRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02324764
• Other study ID #: 20140262
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: March 21, 2019

Study information

• Verified date: January 2022
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 21, 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Embolism
• Embolism and Thrombosis
• Embolism and Thrombosis of the Radial Artery
• Heart Diseases
• Myocardial Ischemia
• Thrombosis

Intervention

Device:
• Glidesheath Slender
testing the efficacy and safety of the new transradial sheath in comparison to the standard 6 french sheath.
• standard 6- French radial sheath

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. — View 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, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radial artery occlusion	Evaluated clinically and by ultrasound	30 days
Secondary	Vascular access site complications	Includes: Radial artery occlusion, bleeding or hematoma, pseudoaneurysm, artery dissection, compartment syndrome of the forearm	up to 30 days
Secondary	Radial artery spasm		participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary	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
Secondary	Sheath kinking	Major requiring sheath exchange or minor	participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary	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