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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
246
Endovascular procedure for peripheral arterial lesions via brachial access
Endovascular procedure for peripheral arterial lesions via femoral access
CHU d'Angers
Angers, France
CHU Bordeaux
Bordeaux, France
CHU Brest
Brest, France
CH de Cholet
Cholet, France
CHD La Roche-sur- Yon
La Roche-sur-Yon, France
Clinique mutualiste porte de Lorient
Lorient, France
CHU Nantes
Nantes, France
Hôpital Paris Saint Joseph
Paris, France
Hôpital privé des Côtes d'Armor
Plérin, France
CHU de Rennes
Rennes, France
...and 1 more locations
Occurrence of at least one complication (yes/no) at the access site
Time frame: Day 30
Occurrence of at least one major systemic complication (yes/no)
Time frame: Day 30
Measure of Quality of Life with the EQ5D-5L questionnary
Time frame: Day 30
Procedure time
Time frame: Day 1
Length of hospital stay.
Time frame: up to 2 years
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