Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent Graft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- JOTEC GmbH
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Clinical success
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Clinical success
时间窗: 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
次要结局
未报告次要终点