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NCT Number: NCT07573644

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

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

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Key information

Conditions

Endovascular Treatments Endovascular Surgery Peripheral Arterial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental arm

Procedure

Endovascular procedure for peripheral arterial lesions via brachial access

Procedure/Standard care

Procedure

Endovascular procedure for peripheral arterial lesions via femoral access

Primary outcomes

  1. Occurrence of at least one complication (yes/no) at the access site

    Time frame: Day 30

Secondary outcomes

  1. Occurrence of at least one major systemic complication (yes/no)

    Time frame: Day 30

  2. Measure of Quality of Life with the EQ5D-5L questionnary

    Time frame: Day 30

  3. Procedure time

    Time frame: Day 1

  4. Length of hospital stay.

    Time frame: up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

BAHAA NASR

CONTACT

[email protected]

+33 02 98 34 74 28

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: BRAVO

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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