Comparison Study of Compression Devices Used in Transradial Coronary Angiography

University of Oslo (UIO)

Status: Completed

Conditions: Injury of Radial Artery; Hemostasis; Peripheral Artery Occlusion

Treatments: Device: RY-STOP hemostasis device; Device: TR-Band, Terumo

Study type: Interventional

Funder types: Other

Identifiers

NCT02583854

573099

Details and patient eligibility

About

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.

Enrollment: 499 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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499 participants in 2 patient groups

Hemostasis achieved by TR Band

Active Comparator group

Description:

After the transradial procedure and randomization TR Band will be applied to achieve hemostasis. Patient experience and complications after the application will be measured.

Treatment:

Device: TR-Band, Terumo

Hemostasis achieved by RY Stop

Experimental group

Description:

After the transradial procedure and randomization, RY Stop will be applied to achieve hemostasis. Patient experience and complications after the application will be measured.

Treatment:

Device: RY-STOP hemostasis device