Randomized Clinical Evaluation of Alpine® vs. Xpedition® Stent Delivery System of the XIENCE® Everolimus-eluting Stent
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Crossing time
研究概览
简要总结
To evaluate and compare the performance of two stent delivery systems for percutaneous coronary intervention with everolimus-eluting stent.
详细描述
Rationale: The current gold standard for percutaneous coronary intervention (PCI) is the second generation drug-eluting stent (DES). The most commonly used DES is the everolimus-eluting stent (EES). New stent delivery systems for PCI with EES are developed to optimize strength, flexibility and pushability of the catheter. The effect on procedural time of new stent delivery systems has not yet been investigated in clinical practice.
Objective: To evaluate and compare the performance of two stent delivery systems for PCI with EES.
Study design: Randomized comparative trial with 500 patients in the University Medical Center Groningen (UMCG).
Study population: All patients undergoing PCI with EES, aged 18 years or older, will be considered for eligibility. Patients will be excluded when scheduled for chronic total occlusion (CTO) PCI or if verbal informed consent cannot be obtained.
Intervention: The first group will undergo PCI with the XIENCE EES using the Alpine stent delivery system, the second group will undergo PCI with the Xpedition stent delivery system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •All patients undergoing PCI with EES, aged 18 years or older
排除标准
- •Chronic total occlusion (CTO) PCI
- •Inability to obtain (verbal) informed consent
研究组 & 干预措施
Xpedition stent delivery system
干预措施: Stent delivery with Xpedition (Device)
Alpine stent delivery system
干预措施: Stent delivery with Alpine (Device)
结局指标
主要结局
Crossing time
时间窗: During PCI procedure
Proportion of procedures with crossing time (from introduction of guidewire to stent deployment) longer than 30 minutes.
次要结局
- Procedural time(During PCI procedure)
- Total procedural costs(During PCI procedure)
- Radiation dose(During PCI procedure)
- Radiation time(During PCI procedure)
- Contrast dose(During PCI procedure)
研究者
Pim van der Harst
Prof. Dr. P. van der Harst
University of Groningen