A Prospective, Multi-Center, Non-Randomized, Single-Arm Trial to Evaluate the Safety and Feasibility of the TriMaxx Coronary Stent in de Novo Coronary Artery Lesions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Major Adverse Cardiac Events(MACE). MACE defined as Cardiac Death, MI(Q-wave and Non Q-wave) and Rarget Vessel Revascularization (TVR)
研究概览
简要总结
The primary objective of the trial is to demonstrate the safety and feasibility of treating coronary artery lesions which have not been previously treated with the TRIMAXX Coronary stent system as compared to the reported results for commercially available non-drug eluting coronary stent systems which are indicated for the same treatments.
详细描述
The TriMaxx study is a prospective, multicenter, non-randomized, single-arm trial intended to demonstrate the safety and feasibility of the TriMaxx Cornary Stent System. The study will enroll 100 subjects with de novo native coronary artery lesions who meet the eligibility criteria and agree to participate in the study. Subjects will be enrolled in a sequential manner. The safety and feasibility of the TRIMAXX stent will be evaluated by comparing the MACE rate that is observed 30 days post-procedure to the MACE rate for commercially available non-drug eluting stents. Secoandry evaluations will include analysis of clinical and angiographic parameters at 6 months. All subjects will undergo assessments at 30 days and at 6 months. Additionally, all subjects will undergo a follow-up angiogram at 6 months.
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
- •Eligible for catheter based treatment
- •Single coronary lesion requiring treatment
- •Lesion is accessible with stent device
- •Completes informed consent for participation
- •Stable condition (no symptoms of heart attack within 72 hours prior to treatment)
排除标准
- •Normal lab values
- •Previous treatment in the affected artery
结局指标
主要结局
Major Adverse Cardiac Events(MACE). MACE defined as Cardiac Death, MI(Q-wave and Non Q-wave) and Rarget Vessel Revascularization (TVR)
时间窗: 30 Days
次要结局
- Clinical Outcome: MACE(6 months)
- Clinical Outcome: Ischemia driven TVR(6 months)
- Clinical Outcome: Ischemia driven Target LesionRevascularization(TLR)(6 months)
- Clinical Outcome: Target Vessel Failure(TVF)(6 months)
- Angiographic Outcome: Device Success defined as achievment of a final residual in-stent stenosis > 30%(by QCA) using the assigned device only(procedural)
- Angiographic Outcome: Lesion Success defined as attainment of a >30% residual in-stent stenosis (by QCA) using any percutaneous method(procedural)
- Angiographic Outcome: Procedural Success without the occurrence of cardiac death, Q-wave or Non Q-wave MI or repeat revascularization of the target lesion during the hospital stay.(hospital stay)
- Angiographic Outcome: Angiographic in-stent and in-segment binary restenosis rate(>/= 50% diameter stenosis)(at 6 months)
- Angiographic Outcome: In-stent, in-segment, proximal, and distal minimum lumen diameter(MLD))(at 6 months)
- Angiographic Outcome: Angiographic in-stent late loss, defined as the difference between the post-procedural MLD and the follow-up MLD(at 6 months)