An interventional study of ILIAC ENDOPROSTHESIS GORE EXCLUDER in Iliac Aneurysm, sponsored by University Hospital, Toulouse. Terminated at 1 site in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2020-08-26.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Treatment
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.
30 studies on the registry are indexed under Iliac Aneurysm; 7 are open to participants now.
This study's enrollment of 3 is below the median of 45 across 15 interventional studies indexed under Iliac Aneurysm.
Browse Iliac Aneurysm studies →University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.
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High surgical risk:
Anatomic criteria:
Exclusion Criteria:
GORE Excluder Iliac Branch Endoprosthesis arm with 'ILIAC ENDOPROSTHESIS GORE EXCLUDER'
Device: ILIAC 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.
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.
Time frame: 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.
Time frame: 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
Time frame: at 12 months after surgery
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
Time frame: peri-operative, at short term (3 months), mean-term (12 months)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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