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Completed

NCT Number: NCT02324764

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glidesheath Slender

Device

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

standard 6- French radial sheath

Device

Primary outcomes

  1. Radial artery occlusion

    Time frame: 30 days

    Evaluated clinically and by ultrasound

Secondary outcomes

  1. Vascular access site complications

    Time frame: up to 30 days

    Includes: Radial artery occlusion, bleeding or hematoma, pseudoaneurysm, artery dissection, compartment syndrome of the forearm

  2. Radial artery spasm

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day

  3. Procedure success

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day

    Defined as ability to finish the angiogram/PCI via the intended access site, without the need to change access site.

  4. Sheath kinking

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day

    Major requiring sheath exchange or minor

  5. Painful sheath removal

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day

    Scored on a scale of 1-10 scoring system

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Acronym: CAPITAL-PRO

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 24, 2014
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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