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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Brest

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental arm

    Procedure/Surgery

    Endovascular procedure for peripheral arterial lesions via brachial access

  • Procedure/Standard care

    Procedure/Surgery

    Endovascular procedure for peripheral arterial lesions via femoral access

Treatment groups

246 Participants
are divided into 2 treatment groups
Group A: Brachial artery accessExperimental treatment 1 intervention
Group B: Femoral artery accessActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: