IVUS-CTO: Comparison of the Effect of Intravascular Ultrasound-guided Versus Angiographic-guided Drug-eluting Stent Implantation on Long-term Clinical Outcomes in Patients With Chronic Complete Occlusion of Coronary Artery Disease: a Prospective, Multicenter, Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,448
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events
研究概览
简要总结
This study aims to evaluate the treatment of Chronic total occlusion (CTO) disease. Whether Intravascular Ultrasonography (IVUS) guiding the implantation of drug-eluting stents (DES) will provide better long-term clinical outcomes compared with conventional angiography
详细描述
The study was a prospective, multicenter, open-label, two-arm, 1:1 randomized controlled, well-designed clinical study.
According to the sample size calculation, a total of 1448 patients with primary CTO lesions were required to participate in the study after the guide wire successfully passed through the lesion (defined as: angiographic indication that the guide wire successfully passed through the CTO lesion and reached the distal true lumen).
The study will be conducted at no more than 45research centers. With competitive enrolment, a maximum of 500 patients can be enrolled at each center or until the study is completed, whichever comes first.
It is recommended that each center enroll at least 20 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
During the study, it is difficult for researchers, operators and patients to blind the method due to objective reasons.
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
- •Clinical inclusion criteria:
- •At least 18 years old
- •Subjects will understand the test requirements, treatment and surgery, and can provide written informed consent
- •Subjects with clinical symptoms of ischemic heart disease or evidence of myocardial ischemia associated with CTO target vessels and scheduled to undergo Percutaneous coronary intervention (PCI)
- •Subjects will receive percutaneous coronary intervention
- •Subjects are willing to accept all treatment and follow-up evaluations required by the protocol
- •Inclusion criteria for angiography:
- •Primary coronary artery CTO lesion with visible collateral circulation
- •Estimation of the time to complete occlusion (TIMI grade 0) ≥3 months based on clinical history and/or comparison with historical angiography or ECG
- •It is suitable for target lesions of 2.25-4.0mm stent implantation
- •The length of CTO lesion should be greater than 20mm
排除标准
- •Pregnant and lactating women
- •Severe coronary artery disease, not suitable for PCI
- •Patients with acute myocardial infarction less than 7 days
- •Long-term contraindications to DAPT (at least 1 year)
- •Known renal insufficiency.20 mL/min / 1.73 ㎡)
- •Left ventricular ejection fraction <35% or cardiogenic shock
- •The ICD implanted/CRT
- •Severe bleeding or stroke within 6 months
- •Have a history of allergy to iodine contrast agents or any known allergy to clopidogrel, ticagrelor, aspirin, or heparin
- •Subjects have been diagnosed or suspected of liver disease, including laboratory evidence of hepatitis
- •Valvular heart disease significantly affecting hemodynamics, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease
- •Diseases that researchers believe may seriously harm patients, such as cancer and mental illness;Or the patient's life expectancy is less than one year and the follow-up cannot be completed;Or other conditions that researchers think might have confounded the results
- •Participate in any other ongoing trial or intend to participate in another clinical trial of a drug or device within 12 months after baseline surgery
- •Angiographic exclusion criteria:
- •The target lesion is located in the left main artery
- •No visible collateral circulation in CTO lesions
- •Target lesion is venous or arterial bypass graft
- •The target vessel occlusion time (TIMI grade 0) < 3 months can be determined
结局指标
主要结局
Major adverse cardiac events
时间窗: The study design was event-driven. When a predetermined number of primary endpoints (number of MACE events = 291) occurs (expected 3 years), the study termination procedure will be initiated and this data will be used for primary end point analysis.
All causes of death, myocardial infarction, stent thrombosis (ARC clear/probable), and clinically driven target vessel revascularization
次要结局
- Left ventricular function improved(Baseline period and one-year follow-up period)
- Percentage stenosis of segmental and stent diameter(The follow-up period was 12 months)
- Clinical success rate(Baseline operative period)
- Cardiogenic death(30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery)
- Binary restenosis rate in segment and stent(The follow-up period was 12 months)
- Minimum lumen diameters in segments and stents(The follow-up period was 12 months)
- Nonfatal myocardial infarction(30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery)
- Target vessel revascularization(30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery)
- Target vessel failure(30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery)
- QCA measurements were obtained immediately in the lumen(Baseline operative period)
- Target lesion failure(30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery)
- Target lesion revascularization(30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery)
- Lumens in segmental vessels and stents were lost(The follow-up period was 12 months)
- MLD measured by QCA(Baseline operative period)
研究者
Yaling Han, M.d., Ph.D.
Academician/chief physician
General Hospital of Shenyang Military Region