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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brachial artery access | Experimental |
| |
| Femoral artery access | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental arm | Procedure | Endovascular procedure for peripheral arterial lesions via brachial access |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of at least one complication (yes/no) at the access site | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BAHAA NASR | Contact | +33 02 98 34 74 28 | bahaa.nasr@chu-brest.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Angers | 49100 | France |
|
All collected data that underlie results in a publication
Data will be available beginning five years and ending fifteen years following the final study report completion
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.
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| Procedure/Standard care | Procedure | Endovascular procedure for peripheral arterial lesions via femoral access |
|
| Day 1 |
| Length of hospital stay. | up to 2 years |
| CHU Bordeaux | Bordeaux | 33000 | France |
|
| CHU Brest | Brest | 29200 | France |
|
| CH de Cholet | Cholet | 49309 | France |
|
| CHD La Roche-sur- Yon | La Roche-sur-Yon | 85000 | France |
|
| Clinique mutualiste porte de Lorient | Lorient | 56100 | France |
|
| CHU Nantes | Nantes | 44008 | France |
|
| Hôpital Paris Saint Joseph | Paris | 75014 | France |
|
| Hôpital privé des Côtes d'Armor | Plérin | 22190 | France |
|
| CHU de Rennes | Rennes | 35000 | France |
|
| CH de Saint Brieuc | Saint-Brieuc | 22000 | France |
|
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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