Complex Coronary Artery Disease Treated With Percutaneous Coronary Intervention - COMPLEX Registry.
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
- 1
- 主要终点
- Target lesion revascularization (TLR)
研究概览
简要总结
COMPLEX Registry is an investigator-initiated, retrospective, high-volume Polish single-center clinical registry enrolling 980 consecutive patients with complex coronary artery lesions treated percutaneously between September 2015 and December 2021. All data were collected prospectively as regards the clinical and technical endpoints. The study aimed to assess the safety and efficacy of new-generation, thin-struts DES in patients with complex CAD at long-term clinical follow-up. The primary endpoint of the study was the occurrence of TLR during follow-up. Secondary endpoints were a procedural success and the occurrence of MACE, including all-cause death, MI, or TLR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •For the inclusion of patients in this study, the complexity of CAD was defined as having at least one of the following characteristics: chronic total occlusion (CTO), lesion length >40 mm, severe calcification assessed by angiography or intravascular imaging examination, multivessel PCI during the same intervention, or true bifurcation defined as any lesion involving both the main vessel (MV), proximal or distal and the ostium of the side branch (SB) (Medina 1,1,1; 1,0,1; or 0,1,1).
排除标准
- •left main stem
- •PCI treated during index procedure;
- •cardiogenic shock,
- •thrombolysis before PCI;
- •12-month follow-up not available
结局指标
主要结局
Target lesion revascularization (TLR)
时间窗: 12 months
During the 12-month follow-up, the incidence of TLR in patients included in the study will be reported. TLR was defined as revascularization post-stenting within the stent or within the 5-mm borders adjacent to the stent.
次要结局
- Major adverse cardiac events (MACE)(12 month)
- Procedural success(Peri-procedural)
研究者
Sylwia Iwanczyk
Principal Investigator
Poznan University of Medical Sciences