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OpenTrials
Completed

NCT Number: NCT02583854

Comparison Study of Compression Devices Used in Transradial Coronary Angiography

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.

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Key information

Conditions

Peripheral Artery Occlusion Hemostasis Injury of Radial Artery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, Norway

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

RY-STOP hemostasis device

Device

TR-Band, Terumo

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Helse Sor-Ost

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 22, 2015
Registry last updated
Apr 10, 2018

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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