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

May 1, 2026 updated by: University Hospital, Brest

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

246

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France, 49100
      • Bordeaux, France, 33000
      • Brest, France, 29200
      • Cholet, France, 49309
      • La Roche-sur-Yon, France, 85000
      • Lorient, France, 56100
        • Clinique mutualiste porte de Lorient
        • Contact:
      • Nantes, France, 44008
      • Paris, France, 75014
        • Hôpital Paris Saint Joseph
        • Contact:
      • Plérin, France, 22190
        • Hôpital privé des Côtes d'Armor
        • Contact:
      • Rennes, France, 35000
      • Saint-Brieuc, France, 22000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brachial artery access
Procedure: Experimental arm
Endovascular procedure for peripheral arterial lesions via brachial access
Active Comparator: Femoral artery access
Procedure: Procedure/Standard care
Endovascular procedure for peripheral arterial lesions via femoral access

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of at least one complication (yes/no) at the access site
Time Frame: Day 30
Day 30

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of at least one major systemic complication (yes/no)
Time Frame: Day 30
Day 30
Measure of Quality of Life with the EQ5D-5L questionnary
Time Frame: Day 30
Day 30
Procedure time
Time Frame: Day 1
Day 1
Length of hospital stay.
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

May 1, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC24.0397

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning five years and ending fifteen years following the final study report completion

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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