prospective multicenter study for the endovascular treatment of iliac aneurysm with the branched e-liac stent graft

Conditions: Iliac Aneurysm; AAA

Summary: in this study, patients will be observed who receive an e-liac stent graft for treatment of isolated iliac aneurysms or an e-liac stent graft in combination with one of the following aaa stent grafts: e-tegra stent graft, endurant aaa stent graft, zenith aaa endovascular graft, gore excluder aaa endoprosthesis for treatment of aorto-iliac aneurysms. objectives of this post-market registry are: primary: to prevent the risk of rupture and death by the treatment of common iliac aneurysm with an iliac branched stent graft (e-liac, jotec) secondary: evaluation of safety and feasibility of the e-liac stent graft system used in endovascular treatment of uni- or bilateral aorto-iliac or iliac aneurysm.


Eligibility criteria:
inclusion criteria: * unilateral or bilateral aorto-iliac or iliac aneurysm * suitable for endovascular repair * patient must be compliant with life- long follow-up investigations * \>18 years old * lliac/femoral access vessel morphology compatible with the implantation procedure and the 18fr (6mm od) delivery system * non-aneurysmal common iliac artery landing area in case of iliac artery aneurysm ≥ 20mm * diameter of the common iliac artery in the proximal landing area: 12mm to 17mm * non-aneurysmal external iliac artery segment distal to the aneurysm ≥15mm * diameter of the external iliac artery in the distal landing area: 8mm to 13mm * non-aneurysmal internal iliac artery segment distal to the aneurysm ≥15mm * angle between external iliac artery and internal iliac artery ≤50° * thrombus free iliac lumen in the area of iliac bifurcation to open hypogastric side branch and to implant covered stent ≥18mm * sufficiently open internal iliac arterv ostium * patients must comply with the instructions for use. * patients with common iliac aneurysm with a diameter ≥30mm when isolated or common iliac aneurysm with a diameter \>25mm when associated with an abdominal aortic aneurysm * unilateral or bilateral common iliac aneurysm * patient's anatomy must be fit for stent graft placement on preoperative angio ct scan. * patient is affiliated to the social security or equivalent system. * the patient must be available for the appropriate follow-up times for the duration of the study. * patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent from. exclusion criteria: * patients who do not meet the instructions for use * patients with one of the contraindications as indicated in the instructions for use * patients with a stenotic internal iliac ostium of \< 4mm in diameter * patients with severe internal iliac atherosclerosis * patients that do not have a suitable landing area in the main stem of the iia (maximum diameter in landing area \<12mm) * patients with pseudoaneurysms * patients with symptomatic and ruptured iliac aneurysms * patients pretreated with a aaa stent graft or a bifurcated vascular graft * patient with thrombocytopenia * patient with an estimated glomerular filtration rate \< 30 ml/min/1,73m2 immediately before the intervention * female of child bearing potential * in the lnvestigator's opinion patient has (a) eo-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements, or impact the scientific integrity of the study * patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints * patient with malignancy needing chemotherapy or radiation * patients with life expectancy of less than 36 months * patient minor or under guardianship

Keywords: iliac side branch