Comparison Study of Compression Devices Used in Transradial Coronary Angiography

Hemostasis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02583854
• Other study ID #: 573099
• Status: Completed
• Phase: N/A
• First received: October 21, 2015
• Last updated: April 9, 2018
• Start date: September 2015
• Est. completion date: November 1, 2017

Study information

• Verified date: April 2018
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: November 1, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Hemostasis
• Injury of Radial Artery
• Peripheral Artery Occlusion

Intervention

Device:
• RY-STOP hemostasis device

• TR-Band, Terumo

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Helse Sor-Ost

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radial artery occlusion	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	Patient experience	Patients will be asked to rate their comfort level associated with the hemostasis device they have been assigned	1-4 hours
Secondary	Device complications	Staff responsible for the application of the hemostasis devices will be asked to observe and record bleeds and hematomas that occur.	1-4 hours