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临床试验/NCT02022878
NCT02022878已完成不适用

Development of Computed Tomography Angiography Prediction Score for Percutaneous Revascularization of Chronic Total Occlusions: Multicenter CT-RECTOR Registry

Kerckhoff Heart Center4 个研究点 分布在 2 个国家目标入组 229 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
229
试验地点
4
主要终点
Successful guidewire crossing through CTO within 30 min

研究概览

简要总结

Chronic total occlusions (CTO) are encountered in almost one-fourth of patients undergoing coronary angiography. The presence of an untreated CTO has been related to adverse clinical prognosis, both in stable angina and acute myocardial infarction, and is often associated with persistent symptomatic angina. Depending on their symptomatic and functional status as well as anatomical complexity, CTO can be treated by optimal medical therapy only or therapy combined with coronary revascularization.

The potential benefits of percutaneous coronary intervention (PCI) in CTO include symptom relief, improved left ventricular function, and potentially a survival advantage associated with success when compared with failed revascularization. Of note, marked advances in endovascular techniques and device technology have resulted in substantial improvements of procedural success rates of PCI in CTO.

In spite of these advances, the vast majority of patients with CTO are still being managed medically or referred for coronary bypass surgery rather than PCI. The most common reason for deferring PCI in patients with CTO appears to be the uncertainty of predicting the procedural outcome of percutaneous revascularization. Further barriers to attempting CTO by PCI include the difficulty of gauging the time required for the procedure and the use of resources.

The CT-RECTOR (Computed Tomography REgistry of Chronic Total Occlusion Revascularization) study was designed to evaluate the application of coronary computed tomography angiography (CTA) for the prediction of procedural outcome of PCI in CTO in an international patient population. The main purpose of this multicenter registry is to develop a noninvasive CTA-based prediction tool (CT-RECTOR Score) for grading CTO suitability for PCI.

详细描述

Coronary CTA has recently emerged as a valuable noninvasive tool to provide guidance during percutaneous treatment of CTO. The main advantages of coronary CTA in characterization of CTO include the 3-dimensional visualization of occlusion trajectory and morphology as well as the exact evaluation of calcifications. Despite this, and although prior single-center studies suggested a potential utility of individual coronary CTA-based CTO characteristics for predicting PCI, there has been no compiled prediction model for grading CTO suitability for PCI in a large cohort of patients.

The CT-RECTOR registry is a retrospective, multicenter observational study of patients undergoing preprocedural coronary CTA before attempted PCI of CTO between 2007 and 2013. The study was designed to enroll 250 consecutive patients at 4 high-volume cluster sites in 2 European countries. CT-RECTOR sites were chosen on the basis of adequate coronary CTA volume and PCI proficiency to reflect the state-of-the-art, ''real-life'' management of patients with CTO.

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

入选标准

  • Patients referred for attempted PCI of CTO as part of their standard of care
  • Performance of coronary CTA with 64-detector rows or greater within 6 weeks before attempted PCI of CTO
  • Native vessel or bypass graft de novo or in-stent restenosis CTO
  • Angiographically defined CTO with TIMI flow 0 and estimated duration over 3 months (the duration of the occlusion was determined based on either a history of sudden chest pain, a previous myocardial infarction in the same target vessel territory, or the time between the diagnosis made from coronary angiography and subsequent PCI)

排除标准

  • Age <18 years

结局指标

主要结局

Successful guidewire crossing through CTO within 30 min

时间窗: Intraprocedural

Successful guidewire crossing through CTO within 30 min (defined as the time from initial insertion of the guidewire into the coronary lumen to the time it was successfully crossed through the lesion or was pulled out of the lumen because of unsuccessful guidewire crossing)

次要结局

  • Successful guidewire crossing through CTO and restoration of flow(Intraprocedural)
  • Successful guidewire crossing through CTO with implantation of stent and restoration of flow(Intraprocedural)

研究者

发起方
Kerckhoff Heart Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Christian W. Hamm

Director, Cardiology Department

Kerckhoff Heart Center

研究点 (4)

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