SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,700
- 试验地点
- 93
- 主要终点
- SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) .
研究概览
简要总结
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions.
详细描述
The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic Sub-Study and the Registry.
The SPIRIT V Registry is a prospective, single arm, multi-center registry evaluating performance of the XIENCE V® EECSS in real-world use, per its Instruction For Use (IFU). 2,700 patients will be enrolled in the SPIRIT V Registry.
The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.
The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.
Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT V Registry study after 2 years.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years
- •able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
- •evidence of myocardial ischemia
- •acceptable candidate for coronary artery bypass graft (CABG) surgery
- •undergo all CIP-required follow-up examinations
- •artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned XIENCE V® EESCC
- •target lesions must be de novo lesions
- •target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate
- •target lesion ≤ 28 mm in length by visual estimate
排除标准
- •Patient is already participating in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
研究组 & 干预措施
1
XIENCE V® Everolimus Eluting Coronary Stent System
干预措施: XIENCE V® Everolimus Eluting Coronary Stent (Device)
结局指标
主要结局
SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) .
时间窗: at 30 days
次要结局
- SPIRIT V Registry: Acute Success (Clinical Procedure Success)(Acute)
- SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible)(at 30 days, 1 and 2 years)
- SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization)(at 30 days, 1 and 2 years)
- SPIRIT V Registry: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and TLR(at 30 days, 1 and 2 years)
- SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR(at 30 days, 1 and 2 years)
- SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and any Revascularization(TLR/TVR/non TVR)(at 30 days, 1 and 2 years)
- SPIRIT V Registry: Acute Success (Clinical Device Success)(Acute)