Assessment of the Novel MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Efficacy assessed by the percentage (%) of in-stent neointimal tissue formation evaluated by Intravascular Ultrasound (IVUS)
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of MagicTouch DCB in reducing late lumen loss / suppressing neointimal tissue formation as assessed by Quantitative Coronary Angiography / Intravascular Ultrasound examination for the treatment of coronary artery lesions ranging from 3.0 mm to 3.5 mm of diameter and lesion length ≤ 15 mm.
详细描述
Prospective, multicenter, randomized study designed to enroll 60 subjects with In-stent Restenosis, To demonstrate the efficacy of MagicTouch Drug-Coated Balloon in reducing late lumen loss / suppressing neointimal tissue formation as assessed by Quantitative Coronary Angiography / Intravascular Ultrasound examination for the treatment of coronary artery lesions ranging from 3.0 mm to 3.5 mm of diameter and lesion length ≤ 15 mm.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be ≥18 and ≤ 80 years of age
- •Symptomatic ischemic heart disease;
- •Acceptable candidate for Coronary Artery Bypass Graft (CABG) or Angioplasty;
- •Target lesion located in a native coronary artery
- •Target lesion (maximum length is 15 mm by visual estimate) covered by a single balloon;
- •Reference vessel diameter must be ≥3.0 to ≤ 3.5 mm by visual estimate;
- •Target lesion ≥50% and <100% stenosed by visual estimate
- •Restenosis of initially stented main vessel.
排除标准
- •Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure;
- •Patient has had a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure;
- •Lesions in bypass grafts or bifurcations
- •Any non-target vessel or lesion intended to be treated during the index procedure, which is an unprotected left main, ostial lesion, chronic total occlusion (CTO), heavily calcified, bifurcation, vein grafts, have angiographic evidence of thrombus, be anything requiring atherectomy, thrombectomy, or pre-treatment with anything other than balloon angioplasty;
- •Patient presents with cardiogenic shock;
- •Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
- •Unprotected left main coronary artery disease with ≥50% stenosis;
- •Totally occluded target vessel (TIMI flow 0);
- •Calcified target lesion(s) which cannot be successfully pre-dilated;
- •A significant (>50%) stenosis proximal or distal to the target lesion that cannot be covered by same single balloon
- •Diffuse distal disease to target lesion with impaired runoff;
- •Left ventricular ejection fraction (LVEF) ≤30% (LVEF must be obtained within 1 months prior to the index procedure).
结局指标
主要结局
Efficacy assessed by the percentage (%) of in-stent neointimal tissue formation evaluated by Intravascular Ultrasound (IVUS)
时间窗: 6-months after procedure
次要结局
- Safety assessed by the composite rate for major adverse cardiac events at 12 months. (MACE: cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and Target vessel revascularization (TVR)(12 months)