A Prospective Randomized Study Comparing the Safety of Percutaneous and Open Brachial Access in the Endovascular Treatment of Peripheral Arterial Lesion

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Brest

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

Qualifiers

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

Treatments tested in this trial

  • Experimental arm
  • Procedure/Standard care

Treatment groups

246 Participants
are divided into 2 treatment groups

Sponsors and collaborators