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Comparison Study of Compression Devices Used in Transradial Coronary Angiography

NCT02583854 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 499

Last updated 2018-04-10

No results posted yet for this study

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

DEVICE

RY-STOP hemostasis device

DEVICE

TR-Band, Terumo

Sponsors & Collaborators

  • Helse Sor-Ost

    collaborator OTHER_GOV

  • Oslo University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-05-15
Completion
2017-11-01

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02583854 on ClinicalTrials.gov