Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease

Complication of Treatment Clinical Trial

— TBA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05892367
• Other study ID #: TBA 1.2
• Status: Completed
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: October 2, 2020

Study information

• Verified date: May 2023
• Source: Wilhelminenspital Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: October 2, 2020
• Est. primary completion date: August 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Complication of Treatment

Intervention

Other:
• Transbrachial Access for Interventions
Adding a positioning splint in addition to compression bandage after intervention in order to guarantee immobilization of puncture site

Locations

Country	Name	City	State
Austria	Department of Vascular and Endovascular Surgery	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Wilhelminenspital Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of local complications at the puncture site	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	6 weeks
Secondary	Post-interventional pain at puncture site	Evaluation of local pain according to V.A.S. score by asking patients after intervention	24 hours