Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures in Underrepresented Patient Populations Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,010
- 试验地点
- 18
- 主要终点
- Target-vessel failure (TVF)
研究概览
简要总结
The IVUS CHIP UPP Registry is a prospective, observational, multicenter, single-arm registry. A total of 1010 patients with complex coronary lesions will be enrolled in up to 2 years, with at least 500 men and women. All patients will be treated with IVUS-guided PCI.
详细描述
Objective is to describe in a United States population the clinical efficacy and safety of an IVUS-guided approach in patients who self-identify within a census-defined minority undergoing PCI of complex coronary lesions, as well as clinical outcomes up to 2 years.
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
- •The patient must be ≥18 years of age and self-identify within a US census-defined minority
- •Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:
- •Angiographic heavy calcification
- •Ostial lesions
- •True bifurcation lesions involving side-branches >2.5mm
- •Left main lesions
- •Chronic total occlusion
- •In-stent restenosis
- •Long-lesions (estimated stent length > 28mm) OR Patient with an indication for PCI for any lesion and in need for elective mechanical circulatory support assisted PCI
- •Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)
- •All lesions must be suitable for treatment with FDA-approved contemporary generation drug eluting stents or drug-coated balloons
- •The patient is willing and able to cooperate with registry procedures and follow-up until registry completion
- •Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she (or an authorized legal representative) provides informed consent prior to any protocol-related procedure, as approved by the appropriate IRB
排除标准
- •ST-elevation myocardial infarction or cardiogenic shock within prior 7 days
- •Known untreated severe valvular heart disease
- •Contraindication on the use of IVUS (i.e. extreme vessel tortuosity)
- •Requiring PCI in a diseased aorto-coronary bypass
- •Known contraindication or hypersensitivity to anticoagulants
- •Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
- •Non-cardiac co-morbidities with a life expectancy less than 1 year
- •A patients that is currently participating in a clinical trial that has not yet reached its primary endpoint cannot be included in this registry. A patient may only be enrolled in this registry once.
研究组 & 干预措施
IVUS-guided PCI in patients traditionally underrepresented in clinical trials
Patients undergoing IVUS-guided PCI for complex coronary artery disease who self-identify within a census-defined minority in the United States
干预措施: IVUS (Device)
结局指标
主要结局
Target-vessel failure (TVF)
时间窗: 1 year after enrollment
TVF is defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization
次要结局
未报告次要终点