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The aim of this project is to demonstrate the benefit of the use of aortic iliac branch endoprosthesis in the iliac aneurysms and to avoid the classic complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GORE Excluder | Experimental | GORE Excluder Iliac Branch Endoprosthesis arm with 'ILIAC ENDOPROSTHESIS GORE EXCLUDER' |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ILIAC ENDOPROSTHESIS GORE EXCLUDER | Device | Set up of GORE ® Excluder Iliac Branch Endoprosthesis in endovascular barring of complex aneurysms without distal neck. In the immediate post-operating follow-up visit and at the 3 months visit and the 12 months visit after surgery, an ultra-sound scan, a tomodensitometric exam and a walking test on a treadmill with oximetric gluteal region exploration will systematically be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion) | Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion. It is a binary criterion (permeable or not) This criterion will be evaluated by a doppler ultrasound. These exams will be performed by a unique vascular physician, who will measure the hemodynamic criterions and the associated gluteal region oximetry. Endoprosthesis will be considered to be permeable if the patient is asymptomatic (absence of gluteal claudication), if Doppler ultrasound and angio-scan confirm the permeability of the endoprosthesis. | At the immediate post-operating follow-up visit |
| Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion) | Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion. It is a binary criterion (permeable or not) This criterion will be evaluated by a doppler ultrasound. These exams will be performed by a unique vascular physician, who will measure the hemodynamic criterions and the associated gluteal region oximetry. Endoprosthesis will be considered to be permeable if the patient is asymptomatic (absence of gluteal claudication), if Doppler ultrasound and angio-scan confirm the permeability of the endoprosthesis. | at 3 months after surgery |
| Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion) | Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion. It is a binary criterion (permeable or not) This criterion will be evaluated by a doppler ultrasound. These exams will be performed by a unique vascular physician, who will measure the hemodynamic criterions and the associated gluteal region oximetry. Endoprosthesis will be considered to be permeable if the patient is asymptomatic (absence of gluteal claudication), if Doppler ultrasound and angio-scan confirm the permeability of the endoprosthesis. Primary permeability will be considered non-maintained at 1 year if a stenosis >70% or a thrombosis of the hypogastric branch is observed by ultra-sound scan at a follow-up visit during the first year after surgery or at a ultra-sound scan exam motivated by pelvic ischemia clinical signs |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | Evaluation of the morbidity:
| peri-operative, at short term (3 months), mean-term (12 months) |
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Inclusion Criteria:
High surgical risk:
Anatomic criteria:
Affiliation to a social security system
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Pierre BOSSAVY, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Toulouse | Toulouse | 31059 | France |
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| ID | Term |
|---|---|
| D017543 | Iliac Aneurysm |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| at 12 months after surgery |