NCT01307553Unknown不适用
OVER AND UNDER/ANEUGRAFT PERICARDIUM COVERED STENT Long Term Follow Up Registry
ITGI Medical2 个研究点 分布在 2 个国家目标入组 75 人开始时间: 2010年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- MACE (Major Adverse Clinical Events)
研究概览
简要总结
The purpose of this study is to track the clinical safety and effectiveness of the Pericardium Covered Stent in "real world" use.
详细描述
This is a multi-center registry of 75 patients treated with the Over and Under/Aneugraft Pericardium Covered Stent (PCS) (IGTI, Israel). The registry will involve the collection of demographic, clinical, and angiographic data on the treated patient population, including in-hospital, 30 day, 6-month, 1 year, 2 years and 3 years clinical follow-up data.
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
- •Patient is older than 18 years
- •Patient must be available for follow-up
- •Patient must be fully informed, provided with the patient information sheet and sign the Informed Consent Form prior to the procedure.
- •The lesion to be treated should be suitable for treatment with a PCS in that:
- •A. A suitable length and diameter PCS should be available
- •B. For SVG disease a single or multiple PCS may be used
- •C. For native coronary artery aneurysms the operator should be confident that the aneurysm may be excluded by the implantation of a single PCS
排除标准
- •Significant co-morbidity precluding clinical follow-up.
- •Pregnancy; pregnancy test negative in women with child bearing potential
- •Acute ST-elevation myocardial infarction within the preceding 48 hours
- •Previous stent implantation in the target vessel
- •Left main coronary artery disease
- •Contra-indication to dual anti-platelet therapy.
- •Planned surgery which will lead to discontinuation of antiplatelet therapy
- •Thrombocytopenia (<100,000/mm3)
- •Ejection fraction <30%.
- •Renal failure (creatinine >180 µmol/L [2 mg/dL])
- •Prior brachytherapy
- •Recipient of heart transplant
- •Acute infections
结局指标
主要结局
MACE (Major Adverse Clinical Events)
时间窗: 6 months
次要结局
- MACE(30 days, 1 Year, 2 Years, 3 Years)
- Hospital readmission due to cardiac reason.(30 days, 6 months. 1 Year, 2 Years, 3 Years)
研究者
研究点 (2)
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