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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2019-03-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Embolism and Thrombosis of the Radial Artery Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Glidesheath Slender

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

Group Type EXPERIMENTAL

Glidesheath Slender

Intervention Type DEVICE

testing the efficacy and safety of the new transradial sheath in comparison to the standard 6 french sheath.

Standard sheath

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

Group Type ACTIVE_COMPARATOR

standard 6- French radial sheath

Intervention Type DEVICE

Interventions

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Glidesheath Slender

testing the efficacy and safety of the new transradial sheath in comparison to the standard 6 french sheath.

Intervention Type DEVICE

standard 6- French radial sheath

Intervention Type DEVICE

Other Intervention Names

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Glidesheath Slender, Terumo, Tokyo, Japan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No