Turkish Chronic Total Occlusion Percutaneous Coronary Intervention Prospective Multicenter Observational Registry: TURK-CTO Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70,000
- 试验地点
- 6
- 主要终点
- Technical Success of CTO PCI
研究概览
简要总结
The TURK CTO Registry is a prospective, multicenter, observational registry designed to evaluate the contemporary management and outcomes of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in Türkiye.
The registry will include consecutive adult patients undergoing CTO PCI at participating centers. Detailed data on patient characteristics, cardiovascular risk factors, lesion and procedural characteristics, CTO crossing strategies, guidewires and devices, procedural techniques, radiation exposure, contrast use, procedural success, and in-hospital complications will be collected using a standardized electronic data collection system.
The primary objective of the registry is to characterize contemporary CTO PCI practice in Türkiye and to evaluate procedural success and safety. Secondary objectives include identifying clinical, angiographic, and procedural factors associated with technical and procedural success, complications, resource utilization, and patient outcomes.
The registry is expected to provide real-world, multicenter data on CTO PCI practice and to help identify factors associated with successful and safe CTO revascularization in Türkiye. No treatment or procedural strategy will be assigned by the study protocol; all clinical and procedural decisions will be made by the treating physicians according to routine clinical practice.
详细描述
The TURK CTO Registry is a prospective, multicenter, observational registry designed to provide comprehensive, real-world data on contemporary percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO) across participating centers in Türkiye. The registry is planned to continue for 10 years and will prospectively enroll consecutive eligible patients undergoing CTO PCI.
The registry will evaluate patient-, lesion-, procedure-, operator-, and center-related characteristics and their associations with procedural strategies, technical and procedural success, complications, and short- and long-term clinical outcomes.
A coronary CTO will be defined as a coronary artery lesion with Thrombolysis in Myocardial Infarction (TIMI) grade 0 antegrade flow and an estimated duration of occlusion of at least 3 months, based on clinical history, previous angiographic findings, or other available clinical information.
Eligibility Criteria Inclusion Criteria
Participants will be eligible for inclusion in the TURK CTO Registry if they meet all of the following criteria:
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
- •Presence of at least one coronary chronic total occlusion (CTO), defined as a coronary artery lesion with TIMI grade 0 antegrade flow and an estimated duration of occlusion of ≥3 months
- •Undergoing an attempted PCI of the CTO at a participating center during the study period
- •Provision of informed consent when required by the applicable ethics committee and local regulations
排除标准
- •Age <18 years
- •Coronary lesion not meeting the predefined criteria for CTO
- •No attempted CTO PCI during the procedure
- •Inability or refusal to provide informed consent when informed consent is required
- •Withdrawal of consent from participation in the registry
研究组 & 干预措施
CTO PCI Cohort
Adult patients (≥18 years) undergoing attempted percutaneous coronary intervention (PCI) for at least one coronary chronic total occlusion (CTO) at participating centers in Türkiye will be prospectively enrolled.
The cohort will include both successful and unsuccessful CTO PCI procedures, as well as repeat CTO PCI attempts. If a patient undergoes more than one CTO PCI attempt or treatment of more than one CTO lesion during the study period, each eligible procedure will be recorded as a separate procedural episode and linked to the same patient using a unique study identifier.
No specific CTO PCI strategy, technique, device, or treatment will be assigned by the study protocol. All procedural and clinical decisions will be made by the treating physicians according to routine clinical practice.
结局指标
主要结局
Technical Success of CTO PCI
时间窗: At the end of the index CTO PCI procedure
Technical success will be defined as successful CTO revascularization resulting in \<30% residual stenosis and restoration of TIMI grade 3 antegrade flow in the treated vessel at the completion of the CTO PCI procedure. The proportion of CTO PCI procedures achieving technical success will be assessed.
Procedural Success of CTO PCI
时间窗: From the CTO PCI procedure through hospital discharge, typically within 7 days
Procedural success will be defined as achievement of technical success without the occurrence of an in-hospital major adverse event. The proportion of CTO PCI procedures meeting the predefined criteria for procedural success will be assessed.
次要结局
- In-Hospital Major Adverse Cardiovascular and Cerebrovascular Events(From the CTO PCI procedure through hospital discharge, typically within 7 days.)
- CTO PCI-Related Procedural Complications(During the CTO PCI procedure through hospital discharge, typically within 7 days.)
- Major Adverse Cardiovascular and Cerebrovascular Events During Follow-up(30 days, 6 months, 12 months, 24 months, and 36 months after the CTO PCI procedure.)
- CTO Target-Vessel Reocclusion(Up to 36 months after the CTO PCI procedure.)
- Change in Left Ventricular Ejection Fraction(Baseline and up to 36 months after the CTO PCI procedure.)
- Total Procedure Duration(During the CTO PCI procedure)
- CTO Crossing Time(From initiation of CTO crossing attempts until successful guidewire crossing of the CTO lesion, during the index CTO PCI procedure)
- Fluoroscopy Time(During the CTO PCI procedure)
- Cumulative Air Kerma(During the CTO PCI procedure)
- Dose-Area Product (DAP)(During the CTO PCI procedure)
- Total Contrast Volume(During the CTO PCI procedure)
- Change in Canadian Cardiovascular Society Angina Classification(Baseline and 30 days, 6 months, 12 months, 24 months, and 36 months after CTO PCI)
- Change in New York Heart Association Functional Classification(Baseline and 30 days, 6 months, 12 months, 24 months, and 36 months after CTO PCI)
研究者
Ahmet Seyfeddin Gürbüz
Professor of Cardiology
Necmettin Erbakan University