A Prospective Randomized Study Comparing the Safety of Percutaneous and Open Brachial Access in t… (NCT07573644) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Prospective Randomized Study Comparing the Safety of Percutaneous and Open Brachial Access in the Endovascular Treatment of Peripheral Arterial Lesion
France246 participantsStarted 2026-06-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of at least one complication (yes/no) at the access site