A ComparIson of Strategies to Prepare Severely Calcified Coronary Lesions - A Prospective Randomized Controlled Trial of Super High-Pressure NC PTCA Balloon Versus Scoring PTCA Balloon in Severely Calcified Coronary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 5
- 主要终点
- Stent expansion index (SEI)
研究概览
简要总结
The objective of this prospective, multicenter, randomized, open-label trial is to evaluate the completeness of stent expansion following a strategy of lesion preparation with either a Super High-Pressure NC PTCA Balloon (OPN NC) or a Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty in an angiographically well-defined group of patients with severely calcified coronary lesions (grade 3) undergoing coronary stent implantation (SYNERGY everolimus-eluting stent (EES)).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age above 18 years and consentable;
- •Persistent angina symptoms despite optimal medical therapy and/or evidence of inducible ischemia;
- •Angiographically-proven coronary artery disease;
- •De novo lesion in a native coronary artery;
- •Target reference vessel diameter between 2.25 and 4.00 mm by visual estimation;
- •Calcification of the target lesion as determined by angiography (grade 3);
- •Unsuccessful lesion preparation (<30% reduction of baseline diameter stenosis) with conventional NC balloon angioplasty
- •Written informed consent.
排除标准
- •Myocardial infarction (within 1 week);
- •Limited long-term prognosis due to other conditions;
- •Target lesion is in a coronary artery bypass graft;
- •Target lesion is an in-stent restenosis;
- •Target lesion is aorto-ostial;
- •Target vessel thrombus.
研究组 & 干预措施
OPN NC
Patients receiving a Super High-Pressure NC PTCA Balloon (OPN NC)
干预措施: Super High-Pressure NC PTCA Balloon (OPN NC) (Device)
NSE Alpha
Patients receiving a Scoring PTCA Balloon (NSE Alpha)
干预措施: Scoring PTCA Balloon (NSE Alpha) (Device)
结局指标
主要结局
Stent expansion index (SEI)
时间窗: intraprocedural
Stent expansion index (SEI), defined as minimum stent area divided by mean reference area in an optical coherence tomography (OCT) quantitative analysis
次要结局
- Rate of vessel perforation(intraprocedural)
- Procedural Success(30 days)
- Complementary lesion preparations(intraprocedural)
- Contrast volume(intraprocedural)
- Angiographic Success(intraprocedural)
- Strategy Success(intraprocedural)
- Acute lumen gain,(intraprocedural)
- Procedure duration(intraprocedural)