AAA, Iliac Aneurysm
Conditions
Keywords
iliac side branch
Brief 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.
Interventions
DEVICEEndovascular aorto-iliac repair
Sponsors
JOTEC GmbH
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success | 30 days follow-up | Clinical success related to the E-liac Stent Graft combines the following criteria (adapted from Chaikof 2002): * Clinical success should be reported on an intent-to-treat Basis * requires successful deployment of the E-liac Stent Graft at the intended location without * Death as a result of iliac aneurysm-related treatment * Type I or III endoleak * E-liac Stent Graft infection * E-liac Stent Graft thrombosis (including internal iliac artery thrombosis) * Aneurysm growth \>3mm in maximum diameter for common iliac aneurysm and \>5mm in maximum diameter for aortic aneurysm at 12, 24, and 36 months follow-up * Common iliac aneurysm rupture * Conversion to open repair * Failure of E-liac Stent Graft integrity |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAdrien Kaladji, Prof.
CHU Rennes
Outcome results
None listed