Evaluation of Peri-surgical Results at Short and Mean Terms of the GORE ® Excluder Iliac Branch Endoprosthesis

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Peri-surgical Results at Short and Mean Terms of the GORE ® Excluder Iliac Branch Endoprosthesis

Conditions
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Iliac Aneurysm

Intervention / Treatment
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* Device: ILIAC ENDOPROSTHESIS GORE EXCLUDER


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High surgical risk: Comorbidity cardiopulmonary Renal insufficiency Hostile abdomen including ascites or portal hypertension Anatomic criteria: Primitive iliac aneurysm superior to 25 mm without collar Primitive iliac length superior to 40 mm Primitive iliac distal diameter superior to 14 mm Presence of internal iliac collar Affiliation to a social security system Exclusion Criteria: Patient without surgical risk Non-respect of the Anatomic criteria Patient with known allergy to the materials of the device Patient with systemic infection Patient with severe renal insufficiency Patient unable to complete the oximetry test Persons under legal protection

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GORE Excluder<br>GORE Excluder Iliac Branch Endoprosthesis arm with 'ILIAC ENDOPROSTHESIS GORE EXCLUDER' | Device: ILIAC ENDOPROSTHESIS GORE EXCLUDER<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | at 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Evaluation of the morbidity: Minor events (no revision surgery needed): General: pulmonary, cardiologic, renal Local: hematoma, false aneurysm, Impaired wound healing Major events (revision surgery needed): Endoleak Thrombosis Rupture | peri-operative, at short term (3 months), mean-term (12 months) |