Endovascular TreatmentsBRAVONCT07573644
A Prospective Randomized Study Comparing the Safety of Percutaneous and Open Brachial Access in the Endovascular Treatment of Peripheral Arterial Lesion
A study testing Experimental arm in people with Endovascular Treatments and Endovascular Surgery, run by University Hospital, Brest at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endovascular Treatments, Endovascular Surgery, Peripheral Arterial
- What is being tested?
- Experimental arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 11 sitesFrance
- Study dates
- 1 Jun 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites
CHU d'Angers
Angers, 49100
jean Picqet, 02 41 35 38 37, jean.picquet@chu-angers.fr
CHU Bordeaux
Bordeaux, 33000
Eric Ducasse, +33 02 41 49 60 00, eric.ducasse@chubordeaux.fr
CHU Brest
Brest, 29200
Bahaa Nasr, +33 02 98 34 74 28, bahaa.nasr@chu-brest.fr
CH de Cholet
Cholet, 49309
Laurent Muller, +33 02 41 49 80 45, laurent.muller@ch-cholet.fr
CHD La Roche-sur- Yon
La Roche-sur-Yon, 85000
Pierre Alexandre Vent, +33 02 51 44 641 8, Pierrealexandre.vent@ght85.fr
Clinique mutualiste porte de Lorient
Lorient, 56100
Jean Baptiste Bocquel, + 33 02 97 64 81 61, jbbocquel@orange.fr
CHU Nantes
Nantes, 44008
Blandine Maurel, +33 240 165 372, blandine.maurel@chunantes.fr
Hôpital Paris Saint Joseph
Paris, 75014
Yann Goueffic, +33 (0)1 44 12 75 91, ygoueffic@ghpsj.fr
Hôpital privé des Côtes d'Armor
Plérin, 22190
Olivier Creton, +33 02 57 24 02 67, Olivier.creton@gmail.com
CHU de Rennes
Rennes, 35000
Adrien Kaladji, 33 (0)2.99.28.95.71, adrien.kaladji@churennes.fr
CH de Saint Brieuc
Saint-Brieuc, 22000
Christophe Robin, +33 02.96.01.70.55, christophe.robin@chstbrieuc.fr
About this study
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
- Being tested
- Experimental arm, Procedure/Standard care
- Keywords
- peripheral arterial, endovascular treatments, endovascular surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental armProcedure or surgery
Endovascular procedure for peripheral arterial lesions via brachial access
Procedure/Standard careProcedure or surgery
Endovascular procedure for peripheral arterial lesions via femoral access
| Study group | Role | What they receive |
|---|---|---|
| Brachial artery access | Experimental | Not described Receives: Procedure: Experimental arm |
| Femoral artery access | Active comparator | Not described Receives: Procedure: Procedure/Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of at least one complication (yes/no) at the access site
Measured: Day 30
Secondary outcomes (4)
Occurrence of at least one major systemic complication (yes/no)
Measured: Day 30
Measure of Quality of Life with the EQ5D-5L questionnary
Measured: Day 30
Procedure time
Measured: Day 1
Length of hospital stay.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endovascular TreatmentsStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573644
- Sponsor's protocol ID
- 29BRC24.0397
- Acronym
- BRAVO
- Status last verified
- May 2026
- First submitted
- 5 Feb 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study Comparing the Safety of Percutaneous and Open Brachial Access in the Endovascular Treatment of Peripheral Arterial Lesion
- ClinicalTrials.gov ID
- NCT07573644
- Acronym / sponsor ID
- BRAVO / 29BRC24.0397
- Keywords
- peripheral arterial, endovascular treatments, endovascular surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brachial artery access | Experimental | Procedure: Experimental arm |
| Femoral artery access | Active comparator | Procedure: Procedure/Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental armEndovascular procedure for peripheral arterial lesions via brachial access | Procedure or surgery | Brachial artery access |
| Procedure/Standard careEndovascular procedure for peripheral arterial lesions via femoral access | Procedure or surgery | Femoral artery access |
Primary outcome
Occurrence of at least one complication (yes/no) at the access site
Time frame: Day 30
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental arm in people with Endovascular Treatments and Endovascular Surgery, run by University Hospital, Brest at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BAHAA NASR (+33 02 98 34 74 28, bahaa.nasr@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of at least one complication (yes/no) at the access site (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.