NCT02209194已完成不适用
PLIANT - A Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With a New Generation of Low Profile E-liac Stent Graft System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- JOTEC GmbH
- 入组人数
- 47
- 试验地点
- 12
- 主要终点
- Primary patency
研究概览
简要总结
The purpose of the study is to evaluate the clinical and technical success as well as safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or bilateral aortoiliac or iliac aneurysm. Main study target is the exclusion of aneurysm with primary patency of the arteria iliaca interna and the arteria iliaca externa on iliac implantation side.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must comply with the indications for use
- •Unilateral or bilateral common iliac aneurysm diameter equal or greater 25mm
- •Unsuitable distal sealing site within the common iliac artery for traditional EVAR
排除标准
- •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
- •Patients with pseudoaneurysms
- •Patients with symptomatic and ruptured iliac aneurysms
- •Patients with one of the contraindications as indicated in the instructions for use
- •Patients pretreated with a bifurcated vascular graft
- •Patient with thrombocytopenia
- •Patient with creatinine >2.4 mg/dl immediately before the intervention
- •Patient with malignancy needing chemotherapy or radiation
- •Patients who are enrolled in another clinical study
- •Patients with life expectancy of less than 36 months
结局指标
主要结局
Primary patency
时间窗: 36 months
Primary Patency
时间窗: 12 months
Endoleak Type I or III
时间窗: 36 months
次要结局
- Rate of complications(36 months)
- Stent graft migration(within 30 days (baseline) and 36 months)
- Stent graft dislodgement(36 months)
- Distal embolization(36 months)
- Rate of death(36 months)
- Change in aneurysm size(within 30 days (baseline) and 36 months)
- Stent graft kinking(36 months)
研究者
研究点 (12)
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