Assessment of the Safety and Efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the Treatment of Single de Novo Bifurcation Lesions in Native Coronary Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 20
- 主要终点
- Angiographic restenosis rate (%)
研究概览
简要总结
The purpose of this trial is to assess the safety and efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the treatment of single de novo bifurcation lesions in native coronary arteries with a main branch reference vessel diameter of 2.5-3.5 mm and side branch reference vessel diameter of 2.0-3.0 mm.
详细描述
The BIPAX clinical trial is a prospective, non-randomized, multicenter, clinical trial evaluating the investigational coronary bifurcation device Nile PAX® in patients with main branch reference vessel diameters >= 2.5 mm and <= 3.5 mm, side branch reference vessel diameters >= 2.0 and <= 3.0 and lesion length <= 14 mm. The trial allows the treatment of a single de novo bifurcation lesion in native coronary arteries following the provisional T-stenting technique with mandatory pre-dilatation of the main branch. In case the side branch requires a stent the treatment will be completed when possible with a Delta PAX® Drug Eluting Side Branch Stent.
The BIPAX clinical trial will enroll 100 patients. All patients will receive Quantitative Coronary Angiography (QCA) after stent implantation and at 9 months follow-up. All patients will have a clinical follow-up at 1, 6, 9 and 12 months and subsequently every year up to 5 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
- •De novo bifurcation lesions following the Medina classification except (0,0,1).
- •Maximum one bifurcation lesion per patient.
- •Single bifurcation lesion per vessel.
- •The patient is at least 18 years of age. The patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional trial.
- •The patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergent coronary artery bypass graft (CABG) surgery.
- •The patient or patient's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical site.
- •The patient agrees to return to the same research facility for all required post-procedure follow-up visits.
排除标准
- •De novo bifurcation lesion Medina (0,0,1).
- •Left main bifurcation.
- •Heavily calcified lesions.
- •Severe tortuous lesions.
- •Documented left ventricular ejection fraction (LVEF) < 30% at most recent evaluation.
- •Women of childbearing potential.
- •Chronic total occlusion (CTO).
- •Previous PCI of the target lesion.
- •Second lesion requiring treatment in target vessel.
- •Second bifurcation lesion requiring treatment.
- •Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures.
结局指标
主要结局
Angiographic restenosis rate (%)
时间窗: 9 months post-procedure
Angiographic restenosis rate of the main branch and side branch by Quantitative Coronary Angiography (QCA).
次要结局
- Clinically-driven Target Vessel Failure (TVF)(9 months post-procedure)
- Target Lesion Revascularization (TLR)(9 months after procedure)
- Target Vessel Revascularization (TVR)(9 months post-procedure)
- Acute success (device, lesion, and procedure)(at procedure)
- Angiographic in-stent Late Lumen Loss (LLL)(9 months post-procedure)
- Minimum luminal diameter (MLD)(9 months post-procedure)
- Angiographic parameters(9 months post-procedure)
- Major Adverse Cardiac Event (MACE) rate(30 days and 9 months post-procedure)