Iliac Aneurysm
Conditions
Brief summary
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.
Interventions
DEVICEILIAC ENDOPROSTHESIS GORE EXCLUDER
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.
Sponsors
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion) | At the immediate post-operating follow-up visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | peri-operative, at short term (3 months), mean-term (12 months) | 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 |
Countries
France
Outcome results
None listed