Skip to main content
OpenTrials
Completed

NCT Number: NCT05892367

Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease

The aim of the present study is an evaluation, whether an immobilization of the upper extremity by means of a positioning splint can help to reduce the incidence of local complications after transbrachial puncture for peripheral arterial interventions, or not.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Vascular and Endovascular Surgery

Vienna, 1160, Austria

About this study

Increasing numbers of peripheral arterial interventions are performed via transbrachial access leading to a higher number of local complications at the puncture site. Patients are demonstrating complications, such as hematoma, false aneurysm, secondary hemorrhage and arterial stenosis or occlusion.

Due to not standardized post-interventional procedure regarding to immobilization a higher risk for local puncture site complication can occur. Usually, a compression bandage its applied to the brachial puncture site. Within this randomized study, patients randomized to the study group will receive an additional splint for 24 hours to ensure an immobilization of the affected arm.

Following the removal of the compression dressing, and the splint in the study group, a duplex ultrasound its performed in order to detect local alterations and pathologies of the brachial artery.

This examination is repeated for each patient in the course of an outpatient control six weeks post-interventionally. Pathologies are documented and treated if necessary.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female and male patients suffering from peripheral arterial occlusive disease with indicated interventions via an transbrachial access (puncture of the left or right brachial artery)
  • age > 18 years
  • approval to participate

Exclusion criteria

  • unability or refusal to participate
  • dialysis patients/AV-fistula interventions
  • usage of closure devices

Treatment and study plan

Transbrachial Access for Interventions

Other

Adding a positioning splint in addition to compression bandage after intervention in order to guarantee immobilization of puncture site

Primary outcomes

  1. Occurrence of local complications at the puncture site

    Time frame: 6 weeks

    Local complications as hematoma, bleeding, pseudoaneurysm, arterial dissection, arterial stenosis, arterial occlusion, AV fistula detected by ultrasound 24 hours after intervention and at time of follow-up six weeks after treatment

Secondary outcomes

  1. Post-interventional pain at puncture site

    Time frame: 24 hours

    Evaluation of local pain according to V.A.S. score by asking patients after intervention

Sponsors and collaborators

Lead sponsor

Wilhelminenspital Vienna

Other

Registry information

Official study title

Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease: Evaluation of Local Complications With or Without Post-interventional Immobilization of the Upper Extremity

Acronym: TBA

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 7, 2023
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.