NCT01939249Unknown不适用
BIOTRONIK-A Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Stent in the Treatment of Subjects With up to Two de Novo Coronary Artery Lesions - IV
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- Biotronik AG
- 入组人数
- 585
- 试验地点
- 45
- 主要终点
- Target Vessel Failure
研究概览
简要总结
BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the Xience Prime / Xience Xpedition (Xience)drug eluting stent system in de novo coronary lesions. The study is powered for non-inferiority with respect to Target Vessel Failure(TVF)at 12 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Subject must provide written informed consent
- •The target reference vessel diameter (RVD) is ≥ 2.50 mm and ≤ 3.75 mm assessed either visually or by online QCA.
- •Target lesion length is ≤ 26 mm (assessed either visual estimate or by online QCA) and can be covered by one study stent
- •Single de novo lesion with ≥ 50% and < 100% stenosis in up to 2 coronary arteries
排除标准
- •Subject has evidence of myocardial infarction within 72 hours prior to the index procedure
- •Planned intervention of non-target vessel(s) within 30 days after the index procedure
- •Planned intervention of target vessel(s) after the index procedure
- •Target lesion is located in the left main
- •Target lesion is located in or supplied by an arterial or venous bypass graft
- •Target lesion involves a side branch > 2.0 mm in diameter by visual estimate or by online QCA
- •Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off
研究组 & 干预措施
Biotronik Orsiro
Experimental
Subjects assigned to Biotronik Orsiro will be treated with Biotronik Orsiro
干预措施: Biotronik Orsiro (Device)
Abbott Laboratories Xience
Active Comparator
Subjects assigned to Abbott Laboratories Xience can be treated with either the Xience Prime or Xience Xpedition drug eluting stent (DES).
干预措施: Abbott Laboratories Xience (Device)
结局指标
主要结局
Target Vessel Failure
时间窗: 12 months post index procedure
次要结局
- Rate of clinically-driven target lesion revascularization (TLR)(1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year)
- Rate of clinically-driven target vessel revascularization (TVR)(1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year)
- Rate of target lesion failure (TLF), defined as composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), emergent coronary artery bypass graft (CABG), any clinically-driven TLR(1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year)
研究者
研究点 (45)
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