Comparison Study of Compression Devices Used in Transradial Coronary Angiography

April 9, 2018 updated by: Anders Opdahl, Oslo University Hospital

The transradial route is used in 90% of the coronary angiograms performed at Oslo University Hospital (OUS), Ullevål. A compression device needs to be applied after the procedure to achieve hemostasis. Patients and staff will benefit from using a device that yields safe and painless hemostasis.

Patients will be randomly assigned to receive either the standard compression device (control group, A) or a recently developed compression device (experimental group, B). The study will be designed as a non-inferiority, prospective randomized controlled trial, with outcome measures being patient comfort during compression time and complication rates. Complications that will be measured are radial artery occlusion (RAO) measured using ultrasound at a follow up visit. Hematomas or bleeds from the puncture site after application of the compression device will also be classified as complications.

The aim of the study is to investigate whether the new device, RY-STOP is non-inferior compared to the standard device, when considering the outcome measures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

499

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing coronary angiograms via the transradial route

Exclusion Criteria:

  • Patients who have a long way to travel for the follow up, ultrasound scan
  • Patients that do not understand Norwegian
  • Patients presenting with acute ST segment elevation myocardial infarction (STEMI)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hemostasis achieved by TR Band
After the transradial procedure and randomization TR Band will be applied to achieve hemostasis. Patient experience and complications after the application will be measured.
Device: TR-Band, Terumo
Experimental: Hemostasis achieved by RY Stop
After the transradial procedure and randomization, RY Stop will be applied to achieve hemostasis. Patient experience and complications after the application will be measured.
Device: RY-STOP hemostasis device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radial artery occlusion
Time Frame: 90-120 days
Subjects wil have an ultrasound scan of their radial artery preformed after their transradial coronary angiogram to see the rate of occluded arteries.
90-120 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient experience
Time Frame: 1-4 hours
Patients will be asked to rate their comfort level associated with the hemostasis device they have been assigned
1-4 hours
Device complications
Time Frame: 1-4 hours
Staff responsible for the application of the hemostasis devices will be asked to observe and record bleeds and hematomas that occur.
1-4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Helse Sor-Ost

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

May 15, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

October 21, 2015

First Submitted That Met QC Criteria

October 21, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 573099

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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