Comparison Study of Compression Devices Used in Transradial Coronary Angiography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

499 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-11-01

Brief Summary

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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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Detailed Description

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Conditions

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Peripheral Artery Occlusion Hemostasis Injury of Radial Artery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

TR-Band, Terumo

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

RY-STOP hemostasis device

Intervention Type DEVICE

Interventions

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RY-STOP hemostasis device

Intervention Type DEVICE

TR-Band, Terumo

Intervention Type DEVICE

Eligibility Criteria

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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)

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes