Comparison Study of Compression Devices Used in Transradial Coronary Angiography

Not Applicable

Completed

• Conditions: Hemostasis; Injury of Radial Artery; Peripheral Artery Occlusion
• Interventions: Device: RY-STOP hemostasis device; Device: TR-Band, Terumo

• Registration Number: NCT02583854
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-21
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-22
• Primary Completion: 2017-05-15
• Study Completion: 2017-11-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 499

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemostasis achieved by RY Stop	RY-STOP hemostasis device	After the transradial procedure and randomization, RY Stop will be applied to achieve hemostasis. Patient experience and complications after the application will be measured.
Hemostasis achieved by TR Band	TR-Band, Terumo	After the transradial procedure and randomization TR Band will be applied to achieve hemostasis. Patient experience and complications after the application will be measured.

Primary Outcome Measures

Name	Time	Method
Radial artery occlusion	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 Outcome Measures

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

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway