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

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ClinicalTrials.gov Identifier: NCT02324764
Recruitment Status : Recruiting
First Posted : December 24, 2014
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Aun Yeong Chong, Ottawa Heart Institute Research Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Embolism and Thrombosis of the Radial Artery Coronary Heart Disease Device: Glidesheath Slender Device: standard 6- French radial sheath Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Use of Glidesheath Slender to Reduce Radial Artery Occlusion and Vascular Access Site Complications Following Transradial Coronary Angiography
Study Start Date : December 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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 Name: 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



Primary Outcome Measures :
  1. Radial artery occlusion [ Time Frame: 30 days ]
    Evaluated clinically and by ultrasound


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324764


Contacts
Contact: Aun-Yeong Chong, MRCP, MD 613 6967000 ext 67280 achong@ottawaheart.ca
Contact: Colleen Chilton 613 6967000 ext 14646 cchilton@ottawaheart.ca

Locations
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Colleen Chilton    +1 613 6967000 ext 14646    cchilton@ottawaheart.ca   
Contact: Lyne Stuewe    +1613 6967000 ext 14646    lstuewe@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Principal Investigator: Aun-Yeong Chong, MRCP, MD University of Ottawa Heart Institute Research Corporation

Publications:
Responsible Party: Aun Yeong Chong, Interventional Cardiologist, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02324764     History of Changes
Other Study ID Numbers: 20140262
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Keywords provided by Aun Yeong Chong, Ottawa Heart Institute Research Corporation:
transradial coronary angiography
radial artery occlusion
coronary heart disease
Glidesheath Slender

Additional relevant MeSH terms:
Embolism and Thrombosis
Heart Diseases
Thrombosis
Embolism
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases