NCT02583854

Comparison Study of Compression Devices Used in Transradial Coronary Angiography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 499 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Peripheral Artery Occlusion
• Hemostasis
• Injury of Radial Artery

Interventions

Type	Name	Description
DEVICE	RY-STOP hemostasis device
DEVICE	TR-Band, Terumo

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-05-15
• Completion: 2017-11-01
• First posted: 2015-10-22
• Last updated: 2018-04-10

Locations

1 site across 1 country: Norway