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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease; Embolism and Thrombosis of the Radial Artery
• Intervention / Treatment: Device: Glidesheath Slender; Device: standard 6- French 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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glidesheath Slender; The transradial procedure will be performed using the glidesheath slender (studied sheath)	Device: Glidesheath Slender; testing the efficacy and safety of the new transradial sheath in comparison to the standard 6 french sheath.; Other Names: Glidesheath Slender, Terumo, Tokyo, Japan
Active Comparator: Standard sheath; The transradial procedure will be performed using the standard 6- French radial sheath (comparator sheath)	Device: standard 6- French radial sheath

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial artery occlusion	Evaluated clinically and by ultrasound	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular access site complications	Includes: Radial artery occlusion, bleeding or hematoma, pseudoaneurysm, artery dissection, compartment syndrome of the forearm	up to 30 days
Radial artery spasm		participants will be followed for the duration of hospital stay, an expected average of 1 day
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
Sheath kinking	Major requiring sheath exchange or minor	participants will be followed for the duration of hospital stay, an expected average of 1 day
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

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Aun-Yeong Chong, MRCP, MD, University of Ottawa Heart Institute Research Corporation

Publications and helpful links

General 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, 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 21, 2019

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 23, 2014
• First Posted (Estimate): December 24, 2014

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: coronary heart disease; radial artery occlusion; transradial coronary angiography; Glidesheath Slender
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Embolism; Thrombosis; Embolism and Thrombosis
• Other Study ID Numbers: 20140262