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

Starting soon · Not applicable

Conditions studied: Endovascular Treatments, Endovascular Surgery, Peripheral Arterial

In brief

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

Key facts

Study ID

NCT07573644

Run by

University Hospital, Brest

People needed

246

Starts

2026-06-01

Expected to finish

2028-06-30

Last updated by the study team

2026-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• CH de Saint Brieuc — Saint-Brieuc, France

Full record on ClinicalTrials.gov

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