NCT02324764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2019

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

4.2 years

First QC Date

December 8, 2014

Last Update Submit

January 27, 2022

Conditions

Embolism and Thrombosis of the Radial ArteryCoronary Heart Disease

Keywords

transradial coronary angiographyradial artery occlusioncoronary heart diseaseGlidesheath Slender

Outcome Measures

Primary Outcomes (1)

  • Radial artery occlusion

    Evaluated clinically and by ultrasound

    30 days

Secondary Outcomes (5)

  • Vascular access site complications

    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

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

  • Sheath kinking

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

  • Painful sheath removal

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

Study Arms (2)

Glidesheath Slender

EXPERIMENTAL

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

Device: Glidesheath Slender

Standard sheath

ACTIVE COMPARATOR

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

Device: standard 6- French radial sheath

Interventions

Glidesheath SlenderDEVICE

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

Also known as: Glidesheath Slender, Terumo, Tokyo, Japan
Glidesheath Slender
standard 6- French radial sheathDEVICE
Standard sheath

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing coronary angiography and/or PCI via transradial approach
  • Informed consent
  • Documented normal Allen's test

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (3)

  • 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.

    PMID: 24461923BACKGROUND

  • 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.

    PMID: 24285594BACKGROUND

  • 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.

    PMID: 22338002BACKGROUND

MeSH Terms

Conditions

EmbolismCoronary DiseaseArterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart Diseases

Study Officials

  • Aun-Yeong Chong, MRCP, MD

    University of Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Cardiologist

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 24, 2014

Study Start

December 1, 2014

Primary Completion

March 1, 2019

Study Completion

March 21, 2019

Last Updated

January 28, 2022

Record last verified: 2022-01

Locations

CA(1)