NCT00597142已完成4 期
A Prospective, Multi-center, Single Arm Study Evaluating the Express™ Renal Premounted Stent System in the Treatment of Atherosclerotic Lesions in the Aortorenal Ostium.
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 27
- 主要终点
- Binary in-stent restenosis rate of the Express™ Renal Stent at nine (9) months, defined by quantitative angiography.
研究概览
简要总结
The purpose of this study is to demonstrate superior 9-month binary restenosis rate of the Express™ Renal Premounted Stent System as compared to an Objective Performance Criterion representative of PTRA, for atherosclerotic lesions in the aortorenal ostium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Eligible for PTRA and stenting.
- •One or more of the following: (1-3)
- •Hypertension
- •Recurrent "flash" pulmonary edema out of proportion to any impairment of left ventricular function
- •Renal Dysfunction
- •Single, de novo, or restenotic (from prior PTRA) atherosclerotic lesion in the ostium of the renal artery
- •Lesion involving the aortorenal ostium or the leading edge of the stenosis is located within 5 mm of the opacified aortic lumen
- •Renal Artery Stenosis: bilateral renal artery stenosis (one stent for one lesion in each renal artery) or unilateral renal artery stenosis, including a solitary functioning kidney
排除标准
- •Any previous or planned, surgery or percutaneous intervention ≤30 days prior to or after index procedure
- •Advanced renal disease: serum creatinine > 3.0 mg/dl
- •End stage renal disease requiring dialysis; or previously diagnosed ephrosclerosis
- •Recent vascular event ≤30 days pre-procedure (i.e. acute coronary syndrome, decompensated heart failure, transient ischemic attack or stroke.)
- •Documented allergy or reaction to iodinated contrast media, including laryngeal edema, convulsions, profound hypotension,unresponsiveness, cardiopulmonary arrest, and clinically manifest arrhythmias (a mild allergy to contrast media that can be pretreated with medication is acceptable)
- •Documented allergy to heparin, acetylsalicylic acid (ASA) or clopidogrel
- •NYHA Class IV
- •Bleeding diathesis
- •Thrombocytopenia (platelets < 100,000/mm3)
- •Renal atrophy (renal length ≤ 8 cm determined by renal ultrasound)
- •Patients requiring immunosuppressive therapy
- •Renal allograft
- •Stenosis location in a vascular graft or in a transplant artery Angiographic Exclusion
- •Total occlusions
- •Thrombus containing lesion
- •Prior treatment of target lesion with stent (in-stent restenosis)
- •More than one (1) lesion in target vessel
- •Non-atherosclerotic stenosis (fibromuscular dysplasia)
- •Excessive vessel tortuosity
- •Lesion involving a side-branch
- •Lesion in accessory renal artery
- •Abdominal aortic aneurysm > 3.5 cm
- •Perforated vessels evidenced by extravasation of contrast media
研究组 & 干预措施
1
Experimental
干预措施: Express™ Renal Premounted Stent System (Device)
结局指标
主要结局
Binary in-stent restenosis rate of the Express™ Renal Stent at nine (9) months, defined by quantitative angiography.
时间窗: 9 months
次要结局
- Change (improvement) in hypertension control from pre-procedure to post-procedure, 30-day and 9-month followups(9 Months)
- Technical success as visually assessed by the investigator.(Immediately after stent deployment)
- Procedural Success - <30% residual diameter stenosis as visually assessed by the investigator without the occurrence of in-hospital MAE.(Post stent deployment)
- Change in Renal to Aortic Ratio, Resistive Index, and Peak Systolic Velocity using Ultrasound Core Lab values from pre-procedure to postprocedure and 9-months post-procedure.(9 Months)
- Major Adverse Events (MAEs): device- or index procedure related death ,TLR, Significant Embolic Event through 9 months post-procedure(9 Months)
- Target Lesion Revascularization(TLR)*- Clinically driven reintervention of the target lesion through 9-months.(9 months)
- Target Vessel Revascularization(TVR)* - Clinically driven reintervention of the target vessel through 9-months.(9 Months)
- Change (improvement) in renal function from pre-procedure to post-procedure, 1-month and 9-month followups(9 months)
研究者
研究点 (27)
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