DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions (DYNAMITE Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in mean in-device lumen area and mean device area
研究概览
简要总结
The aim of the DYNAMITE study is to investigate the (a) acute procedural and (b) 9-month follow-up performance of DynamX Drug-Eluting Coronary Bioadaptor System implantation in complex coronary lesions.
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
盲法说明
All imaging analyses will be performed at an independent core laboratory (Cardiovascular Department, San Giovanni Addolorata Hospital, Rome, Italy) by experienced operators blinded to procedural data and clinical outcomes.
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
- •Presence of complex coronary lesions defined as follows:
- •long lesions (>28 mm);
- •CTO, a total occlusion of duration more than 3-months;
- •Lesions involving a bifurcation, defined as a division with a side branch large enough to be stented (i.e. >2.25 mm);
- •Patients requiring 4 or more stents
- •Reference vessel diameter: >2.25 mm to <4.0 mm
排除标准
- •Age under 18 years old;
- •Significant co-morbidity precluding clinical follow-up;
- •A positive pregnancy test in women with child-bearing potential;
- •Contra-indication to dual anti-platelet therapy;
- •Thrombocytopenia <100,000/uL;
- •Major surgery planned which will lead to discontinuation of antiplatelet therapy;
- •In-stent restenosis;
- •Treatment of saphenous vein graft;
- •CTO with long sub-intimal tracking (> 20 mm).
研究组 & 干预措施
DynamX Drug-Eluting Coronary Bioadaptor System
干预措施: DynamX Drug-Eluting Coronary Bioadaptor System (Device)
结局指标
主要结局
Change in mean in-device lumen area and mean device area
时间窗: Through 9 months
Change in mean in-device lumen area and mean device area, as measured by Optical coherence tomography (OCT)
次要结局
- Cardiac Death (CD)(9 months, 12 months and 24 months)
- Myocardial Infarction (MI)(9 months, 12 months and 24 months)
- Percentage of intimal hyperplasia(9 months)
- Target Lesion Revascularization (TLR)(9 months, 12 months and 24 months)
- Stent Thrombosis (ST)(9 months, 12 months and 24 months)
- Minimum stent diameter(9 months)
- Intimal hyperplasia (IH) area(9 months)
- Stent Cross-Sectional Area(9 months)
- Major Adverse Cardiac Event (MACE)(9 months, 12 months and 24 months)
- Maximum stent diameter(9 months)
研究者
Dr. Antonio Colombo
Dr. Antionio Colombo, Senior Consultant - Cardio Center, Clinical and Interventional Cardiology Unit, IRCCS Humanitas Research Hospital, Rozzano, Italy
Istituto Clinico Humanitas