NCT00180310已完成3 期
A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 40
- 主要终点
- In-stent late loss (LL)
研究概览
简要总结
Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System.
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.
详细描述
The SPIRIT II trial was a randomized, single blind, active control, multi-center clinical evaluation. Subject eligibility criteria were similar to SPIRIT III and enrollment duration overlapped between studies. In this study, 300 subjects (3:1 randomization XIENCE V® EECSS: TAXUS™ PECSS were enrolled at 31 sites outside the United States. The primary endpoint was in-stent late loss at 6 months. Secondary endpoints included clinical outcomes at months 1, 6, and 9 months and 1, 2, 3, 4 and 5 years; angiographic results at 6 months and 2 years; and IVUS results at 6 months and 2 years. Follow-up through 3 years is currently available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •De novo Target lesion(s) must be located in a native epicardial vessel with diameter between 2.25 mm and 4.25 mm by visual estimate
- •The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and < 100% with a TIMI flow of >= 1
- •Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done >= 90 days prior to the index procedure or if planned to be done > 9 months after the index procedure
排除标准
- •De novo target lesion(s) located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure
- •Target lesion(s) restenotic from previous intervention
- •Target lesion(s) located in a major epicardial vessel that has been previously treated with brachytherapy
- •Target vessel(s) contains visible thrombus
- •Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)
- •Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required
结局指标
主要结局
In-stent late loss (LL)
时间窗: at 180 days
次要结局
- In-segment Late Loss(at 180 days (all patients) and at 2 years (for a subset of 152 patients))
- In-stent Late Loss at 2 years (for a subset of 152 patients)(at 2 years (for a subset of 152 patients))
- Proximal and distal Late Loss(at 180 days (all patients) and at 2 years (for a subset of 152 patients))
- In-stent and in-segment Angiographic Binary Restenosis (ABR) rate(at 180 days (all patients) and at 2 years (for a subset of 152 patients))
- In-stent and in-segment percent Diameter Stenosis (% DS)(at 180 days (all patients) and at 2 years (for a subset of 152 patients))
- In-stent percent Volume Obstruction (% VO)(at 180 days and at 2 years for a subset of 152 patients)
- Plaque behind the stent( by IVUS)(at 180 days and at 2 years for a subset of 152 patients)
- Ischemia Driven Major Adverse Cardiac Event (ID-MACE) rate(at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years)
- Ischemia Driven Target Vessel Failure (ID-TVF)(at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years)
- Ischemia Driven Target Lesion Revascularization (ID-TLR)(at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years)
- Persisting incomplete stent apposition, late-acquired incomplete stent apposition(at 180 days and at 2 years for a subset of 152 patients)
- Aneurysm, thrombosis and persisting dissection(at 180 days (all patients) and at 2 years (for a subset of 152 patients))
- Acute success(device, procedure and clinical)(Acute)
研究者
研究点 (40)
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