Comparison Study of Compression Devices Used in Transradial Coronary Angiography

NCT02583854 | Completed DMC

• 1 other identifier: 573099
• Study Type: interventional
• Target: 499
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Occlusion; Hemostasis; Injury of Radial Artery

Keywords

Coronary angiography; Transradial; Patient experience; VAS; Compression device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient experience

  1-4 hours

• Device complications

  1-4 hours

Study Arms (2)

Hemostasis achieved by TR Band

ACTIVE COMPARATOR

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

Device: TR-Band, Terumo

Hemostasis achieved by RY Stop

EXPERIMENTAL

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

Device: RY-STOP hemostasis device

Interventions

RY-STOP hemostasis device DEVICE

Hemostasis achieved by RY Stop

TR-Band, Terumo DEVICE

Hemostasis achieved by TR Band

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing coronary angiograms via the transradial route

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oslo University Hospital: lead
• Helse Sor-Ost: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

• Due-Tonnessen N, Egeland CH, Meyerdierks OJ, Opdahl A. Is radial artery occlusion and local vascular complications following transradial coronary procedures affected by the type of haemostasis device used? A non-inferiority Randomized Controlled Trial (RadCom trial). Eur J Cardiovasc Nurs. 2021 Aug 20;20(6):580-587. doi: 10.1093/eurjcn/zvab004.

  PMID: 33615328 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: October 22, 2015
• Study Start: September 1, 2015
• Primary Completion: May 15, 2017
• Study Completion: November 1, 2017
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

NO (1)