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Not yet recruitingNCT07573644BRAVOUpdated May 7, 2026

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

An interventional study of Experimental arm and Procedure/Standard care in Endovascular Treatments, Endovascular Surgery and Peripheral Arterial, sponsored by University Hospital, Brest. Not yet recruiting at 11 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by University Hospital, Brest · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
246
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Endovascular Treatments
  • Endovascular Surgery
  • Peripheral Arterial

Keywords

  • peripheral arterial
  • endovascular treatments
  • endovascular surgery
03

In context

Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
246 participants (estimated)

Study arms

  • Experimental
    Brachial artery access

    Procedure: Experimental arm

  • Active comparator
    Femoral artery access

    Procedure: Procedure/Standard care

Interventions

  • ProcedureExperimental arm

    Endovascular procedure for peripheral arterial lesions via brachial access

  • ProcedureProcedure/Standard care

    Endovascular procedure for peripheral arterial lesions via femoral access

06

What researchers measure

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

07

Study locations

11 sites
08

References and documents

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07573644
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
May 7, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
May 7, 2026

Study contacts

BAHAA NASR
Contact
bahaa.nasr@chu-brest.fr
+33 02 98 34 74 28

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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