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

University of Ottawa Heart Institute

Status: Completed

Conditions: Embolism and Thrombosis of the Radial Artery; Coronary Heart Disease

Treatments: Device: Glidesheath Slender; Device: standard 6- French radial sheath

Study type: Interventional

Funder types: Other

Identifiers

NCT02324764

20140262

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Glidesheath Slender

Experimental group

Description:

The transradial procedure will be performed using the glidesheath slender (studied sheath)

Treatment:

Device: Glidesheath Slender

Standard sheath

Active Comparator group

Description:

The transradial procedure will be performed using the standard 6- French radial sheath (comparator sheath)

Treatment:

Device: standard 6- French radial sheath