PrOgnostic imPlicaTIons of 2-diMensIonal Patterns for Residual Disease After Stenting CharacteriZEd by Quantitative Flow Ratio Pullback Curve Analysis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,607
- 主要终点
- Vessel-oriented composite outcome
研究概览
简要总结
The purpose of this study is to investigate the prognostic values of 2-dimensional residual disease patterns determined by quantitative flow ratio (QFR) pullbacks after stent implantation.
详细描述
Prognostic value of post-percutaneous coronary intervention (PCI) percutaneous coronary intervention (PCI) physiology assessment has been confirmed. The rationale for measuring post-PCI physiologic outcome is that it could implicate the residual risk of suboptimal stenting in addition to residual diffuse coronary artery disease after PCI Nevertheless, it should be noted that both post-PCI physiologic indices such as ,fractional flow reserve (FFR) and QFR, are measured at the distal of the interrogated vessel and reflect the cumulative residual disease burdens, defining the residual disease patterns might have additional role in exploring the underlying mechanisms for suboptimal post-PCI physiologic results, thus providing the opportunities for functional optimization with subsequent interventions accordingly to improve immediate functional results, long-term outcomes may be positively affected.
Concept of physiologic 2-dimensional disease patterns according to both physiologic distribution (predominant focal versus diffuse disease) and local severity (presence versus absence of major gradient) of coronary atherosclerosis before PCI was proposed and could be derived from virtual QFR pullback curve. Nevertheless, the prognostic value of the 2-dimensional residual disease patterns after PCI has not been studied yet.
The CHART-OPTIMIZE study aims to investigate the clinical implications of physiologic 2-dimensional residual disease patterns after stenting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Patients with at least one vessel with measurable post-PCI QFR
- •PPG index can be calculated from virtual QFR pullback curve
- •dQFR/ds can be calculated from virtual QFR pullback curve
- •The patient is willing to comply with specified follow-up evaluations;
- •Patients who agree to accept the follow-up visits.
排除标准
- •Culprit vessels for ACS myocardial infarction;
- •Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure;
- •Patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
- •Patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, rapamycin, styrene-butylenes-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately pre-medicated;
- •Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
- •Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up.
结局指标
主要结局
Vessel-oriented composite outcome
时间窗: at 2 years from index procedure
Vessel-oriented composite outcome (VOCO) including vessel related ischemia-driven target vessel revascularization, vessel-related myocardial infarction (MI), and cardiac death.
次要结局
- Cardiac death or vessel-related MI(at 2 years from index procedure)
- Vessel-related MI(at 2 years from index procedure)
- Cardiac death(at 2 years from index procedure)
- Ischemia-driven target vessel revascularization(at 2 years from index procedure)