Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent, Comparing a Sirolimus Coated Versus an Uncoated Stent in REnal Artery Treatment.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 6
- 主要终点
- assessment of the angiographical in-stent minimal lumen diameter
研究概览
简要总结
The primary objective of this study is to compare the safety and performance of the Palmaz Genesis™ balloon expandable stent, with or without sirolimus coating in the treatment of renal artery stenosis, measured at 6 months follow up via angiography.
详细描述
Multi-center, prospective, controlled, non-randomized investigational feasibility study. One hundred (100) patients with de novo or restenotic renal artery lesions consisting of >= 50% stenosis and reference vessel of >= 4.0 to <= 8.0 mm in diameter will be sequentially included, 50 without sirolimus coating, followed by 50 with sirolimus coating Palmaz GenesisTM. Patients will be followed for 24 months post-procedure, with all patients having clinical assessments at discharge, 1,6, 12 and 24 months. This study will be conducted at twelve investigational sites.
It is anticipated that the total length of time required to complete the study will be 46 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical indication for renal artery revascularization of atherosclerotic renal artery stenosis >=50% as measured by operator or estimated original vessel diameter, based on healthy vessel segment and contralateral side.
- •The reference vessel renal artery must be >= 4mm and <= 8 mm by visual estimate.
- •The patient must have a baseline serum creatinine of <= 5.0 mg/dl.
排除标准
- •Total occlusion of the renal artery.
- •Lesions which would require more than 2 stents.
- •Lesions which are in arteries to transplanted or bypassed kidneys.
- •Abdominal aortic aneurysm > 4.0 cm in diameter.
- •Patients with ASA classification >=4.
结局指标
主要结局
assessment of the angiographical in-stent minimal lumen diameter
时间窗: 6-months follow up
次要结局
- clinical primary patency(discharge, 1, 6 and 12 months post-procedure)
- procedural success(post-procedure)
- worsening renal function(30 days, 6 months, 12 months)
- change in blood pressure measurement(30 days, 6 months, 12 months)
- significant embolic events causing end-organ damage(30 days, 6 months, and 12 months)