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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
499
Oslo University Hospital
Oslo, Norway
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.
Time frame: 90-120 days
Patient experience
Patients will be asked to rate their comfort level associated with the hemostasis device they have been assigned
Time frame: 1-4 hours
Device complications
Staff responsible for the application of the hemostasis devices will be asked to observe and record bleeds and hematomas that occur.
Time frame: 1-4 hours
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