Artimes Pro Low Profile 1.00mm and 1.25mm Dilatation Catheters for Pre-Dilatation of Stenosis and Occlusion in Patients With Symptomatic Ischemic Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Procedure Success
研究概览
简要总结
This is a prospective, non-randomized, open label, multi-center study including 60 patients with symptomatic ischemic heart disease with 70%-100% coronary artery stenoses and occlusions enrolled and treated in this investigational device study.
详细描述
Patients who require initial pre-dilatation using the study device, and then undergo definitive therapy using additional PTCA catheters and stents, according to standard of care will be enrolled in this study.
A maximum of 60 subjects with native coronary artery lesions or occlusions will be treated using the Artimes pro Balloon Dilatation Catheters in a 3:1 ratio using the 1.0mm and 1.25mm dilatation catheters for pre-dilatation and will complete the study within the U.S. This equals 45 patients treated using the 1.0mm dilatation catheter, and 15 patients treated with the 1.25mm dilatation catheter for a total of 60 subjects enrolled and treated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 of age;
- •Willing and able to provide informed consent;
- •Willing and able to meet all study requirements;
- •Patients with symptomatic ischemic heart disease due to stenotic lesions or occlusions in coronary arteries that are amenable to percutaneous coronary interventions;
- •Patients who tolerate DAPT
排除标准
- •A known hypersensitivity or contraindication to aspirin, heparin, or bivalirudin, anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-medicated;
- •LVEF < 30%;
- •Evidence of an acute myocardial infarction within 72 hours of the intended index procedure;
- •Planned treatment of unprotected left main disease;
- •History of cerebral vascular accident (CVA) within 6 months prior to consideration for this study;
- •Transient ischemic attack (TIA) within 6 months prior to consideration for this study;
- •Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months prior to consideration for this study;
- •History of bleeding diathesis or coagulopathy;
- •Refuses blood transfusions;
- •Any general contraindication to revascularization procedures;
- •Pregnant or lactating;
- •In the judgement of the investigator, patient is not a suitable candidate for this study.
结局指标
主要结局
Procedure Success
时间窗: Day 1 - Index Procedure
Delivery of the catheter to and across lesion; inflation and deflation of the catheter; no vessel perforation, dissection or reduction in TIMI flow; and achievement of final TIMI flow grade 3.
次要结局
- Anticipated Adverse Events(Day 1 - Index Procedure)