Endovascular Surgery, Endovascular Treatments, Peripheral Arterial
Conditions
Keywords
peripheral arterial, endovascular treatments, endovascular surgery
Brief summary
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
Interventions
PROCEDUREExperimental arm
Endovascular procedure for peripheral arterial lesions via brachial access
PROCEDUREProcedure/Standard care
Endovascular procedure for peripheral arterial lesions via femoral access
Sponsors
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Presence of a stent at the puncture site * Acute upper limb ischemia * Life expectancy of less than one month * Patient refusal to participate in the study * Allergy to aspirin or clopidogrel * Pregnant woman * Patients not speaking the French language, refusing or unable to comply with the follow-up proposed in the study * Requirement for another endovascular procedure or open surgery within 30 days following the BRAVO study procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of at least one complication (yes/no) at the access site | Day 30 |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of at least one major systemic complication (yes/no) | Day 30 |
| Measure of Quality of Life with the EQ5D-5L questionnary | Day 30 |
| Procedure time | Day 1 |
| Length of hospital stay. | up to 2 years |
Countries
France
Contacts
CONTACTBAHAA NASR
Outcome results
None listed