About this trial
Endovascular treatment tends to replace open surgery in the management of peripheral arterial disease. Access via the common femoral artery remains the primary approach for peripheral arterial interventions. Brachial artery access has emerged as a valid alternative when femoral access is not feasible. Brachial access can be achieved either percutaneously or through an open surgical approach at the elbow.
A limited number of studies have reported complication rates associated with open and percutaneous brachial access in the treatment of peripheral arterial disease. These studies have shown higher complication rates for percutaneous access (ranging from 6% to 9%) compared with open brachial access (ranging from 1% to 2%). However, no direct comparison between the two approaches has been reported to date.
This study is the first to provide a direct, prospective, randomized comparison between open brachial access and percutaneous brachial access
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Endovascular diagnostic or therapeutic procedure via the brachial approach compatible with a 5F to 7F introducer
Patient affiliated with a social security scheme
Disqualifiers
Adult patient under legal guardianship or curatorship
Contraindication to endovascular treatment
History of brachial artery puncture within the past 1 month
History of open surgical approach at the elbow
Trial design
Parallel
Treatments tested in this trial
Experimental arm
Procedure/SurgeryEndovascular procedure for peripheral arterial lesions via brachial access
Procedure/Standard care
Procedure/SurgeryEndovascular procedure for peripheral arterial lesions via femoral access
Treatment groups
Trial outcomes
Primary outcomes
Occurrence of at least one complication (yes/no) at the access site
Secondary outcomes
Occurrence of at least one major systemic complication (yes/no)
Measure of Quality of Life with the EQ5D-5L questionnary
Procedure time
Length of hospital stay.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: