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

NCT07573644 | Not Yet Recruiting

• 1 other identifier: 29BRC24.0397
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 11

Brief 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

Conditions

Endovascular Treatments; Endovascular Surgery; Peripheral Arterial

Keywords

peripheral arterial; endovascular treatments; endovascular surgery

Outcome Measures

Primary Outcomes (1)

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

  Day 30

Secondary Outcomes (4)

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

  Day 30

• Measure of Quality of Life with the EQ5D-5L questionnary

  Day 30

• Procedure time

  Day 1

• Length of hospital stay.

  up to 2 years

Study Arms (2)

Brachial artery access

EXPERIMENTAL

Procedure: Experimental arm

Femoral artery access

ACTIVE COMPARATOR

Procedure: Procedure/Standard care

Interventions

Experimental arm PROCEDURE

Endovascular procedure for peripheral arterial lesions via brachial access

Brachial artery access

Procedure/Standard care PROCEDURE

Endovascular procedure for peripheral arterial lesions via femoral access

Femoral artery access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (11)

CHU d'Angers

Angers, 49100, France

Location

CHU Bordeaux

Bordeaux, 33000, France

Location

CHU Brest

Brest, 29200, France

Location

CH de Cholet

Cholet, 49309, France

Location

CHD La Roche-sur- Yon

La Roche-sur-Yon, 85000, France

Location

Clinique mutualiste porte de Lorient

Lorient, 56100, France

Location

CHU Nantes

Nantes, 44008, France

Location

Hôpital Paris Saint Joseph

Paris, 75014, France

Location

Hôpital privé des Côtes d'Armor

Plérin, 22190, France

Location

CHU de Rennes

Rennes, 35000, France

Location

CH de Saint Brieuc

Saint-Brieuc, 22000, France

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

BAHAA NASR

CONTACT

+33 02 98 34 74 28; bahaa.nasr@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion
• 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.

Locations

FR (11)