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Not yet recruiting NCT07573644

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

No phase Interventional Endovascular Treatments Endovascular Surgery Peripheral Arterial

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Experimental arm, Procedure/Standard care.
Who it may be relevant to
Registry conditions: Endovascular Treatments, Endovascular Surgery, Peripheral Arterial. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Procedure Experimental arm
    Endovascular procedure for peripheral arterial lesions via brachial access
  • Procedure Procedure/Standard care
    Endovascular procedure for peripheral arterial lesions via femoral access

Primary outcome measures

  • Occurrence of at least one complication (yes/no) at the access site [Time frame: Day 30]
Secondary outcome measures (4)
  • Occurrence of at least one major systemic complication (yes/no) [Time frame: Day 30]
  • Measure of Quality of Life with the EQ5D-5L questionnary [Time frame: Day 30]
  • Procedure time [Time frame: Day 1]
  • Length of hospital stay. [Time frame: up to 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 11 centers
  • CHU d'Angers — Angers
  • CHU Bordeaux — Bordeaux
  • CHU Brest — Brest
  • CH de Cholet — Cholet
  • CHD La Roche-sur- Yon — La Roche-sur-Yon
  • Clinique mutualiste porte de Lorient — Lorient
  • CHU Nantes — Nantes
  • Hôpital Paris Saint Joseph — Paris
  • … and 3 more centers

Identifiers

NCT: NCT07573644 · 29BRC24.0397

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗