A Post-Approval Study of the RotablatorTM Rotational Atherectomy System in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 980
- 试验地点
- 19
- 主要终点
- Major adverse cardiovascular event (MACE) (primary safety endpoint)
研究概览
简要总结
Rotational atherectomy (RA) facilitates percutaneous coronary intervention for complex de novo lesions with severe calcification. Some observational studies and a small randomized trial indicated that a strategy of routine RA did not conferred reduction in restenosis or MACE, but these studies are limited by missing follow-up, insufficient power to compare outcomes, and confounding factors in the RA group (long lesion length, etc.). With recent developments in medical therapy, advances in design and delivery of drug-eluting stents (DES), and advances in noninvasive and intravascular coronary imaging, the use of RA in current real-world practice remains to be well determined. We aimed to compile real-world clinical outcomes data for the RotablatorTM Rotational Atherectomy System in routine clinical practice in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 ≥18 years old
- •Subject who is clinically indicated for PCI/stenting
- •Written informed consent
- •Subject is willing to comply with all protocol-required follow-up evaluation
- •Subject must meet one of following angiographic/procedural inclusion criteria:
- •Target lesion is moderately to severely calcified by visual estimate
- •Unsuccessful balloon dilatation of the target lesion
- •Unsuccessful passage of device(s) (microcatheter, balloon, or stent) across the target lesion
排除标准
- •Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI within 2 weeks
- •Subject has any of the following angiographic findings:
- •Thrombus present in the target vessel (by visual estimate)
- •Significant dissection present in the target vessel (NHLBI types C-F)
- •Lesion angulation > 60°(by visual estimate)
结局指标
主要结局
Major adverse cardiovascular event (MACE) (primary safety endpoint)
时间窗: 30 days
The composite of any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI), or cardiac death. Periprocedural myocardial infarction, defined as in patients with normal baseline CK-MB, the peak CK-MB measured within 48 hours of the procedure rises to ≥ 10 x the local laboratory ULN, or to ≥ 5 x ULN with new pathologic Q-waves in ≥ 2 contiguous leads or new persistent LBBB (according to SCAI definition. J Am Coll Cardiol 2013;62:1563-70)
Procedural success rate (primary efficacy endpoint)
时间窗: Peri-procedural
A mean lesion diameter stenosis \<30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of in-hospital MI, target vessel revascularization (TVR), or cardiac death
次要结局
- Target lesion failure (TLF) rate(At 30 days and 12 months post-index procedure)
- TLR rate(At 30 days and 12 months post-index procedure)
- Target vessel failure (TVF) rate(At 30 days and 12 months post-index procedure)
- TVR rate(At 30 days and 12 months post-index procedure)
- Cardiac death rate(At 30 days and 12 months post-index procedure)
- All-cause death rate(At 30 days and 12 months post-index procedure)
- All-cause death or MI rate(At 30 days and 12 months post-index procedure)
- All-cause death, MI, or TVR rate(At 30 days and 12 months post-index procedure)
- Stent thrombosis (ST) rate(At 30 days and 12 months post-index procedure)
- MI rate(At 30 days and 12 months post-index procedure)
- Cardiac death or MI rate(At 30 days and 12 months post-index procedure)
- Subgroup analyses of MACE(At 30 days and 12 months post-index procedure)
- Non-cardiac death rate(At 30 days and 12 months post-index procedure)
研究者
Shao-Ping Nie
Professor of Medicine, Director, Center for Coronary Artery Disease, Division of Cardiology
Beijing Anzhen Hospital