DEFINE PCI: Physiologic Assessment of Coronary Stenosis Following PCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 28
- 主要终点
- Number of Participants With Residual Ischemia (iFR <0.90)
研究概览
简要总结
This is a pilot study designed to assess the relationship between iFR (instantaneous wave-free ratio) pullback and the distribution of coronary atheroma/stenoses as assessed by Quantitative Coronary Angiography (QCA) post angiographically successful PCI (Percutaneous Coronary Intervention).
详细描述
DEFINE-PCI is a multi-center, prospective, non-significant risk study in up to 25 centers in USA and internationally. Consented subjects with CAD (Coronary Artery Disease) who undergo physiologic lesion assessment with iFR<0.90 in at least 1 coronary artery are eligible for participation. After successful PCI to all culprit lesions based on angiographic assessment of the treating physician, a blinded post-PCI iFR and iFR pullback will be performed. The proportion of patients with impaired post-PCI iFR will be assessed, and the number of patients in whom ischemia could theoretically be normalized with further PCI determined. Additionally, the association between the post-PCI iFR results and cardiovascular events and clinical symptoms will be assessed. Follow-up will be at 1, 6 and 12 months, including administration of quality of life questionnaires.
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
- •Subject must be > 18 years old
- •Subjects presenting with stable angina, silent ischemia or non-ST-elevation ACS (acute coronary syndrome) (unstable angina or biomarker positive)
- •Single vessel CAD with at least 2 separate lesions (≥10 mm apart) of ≥40% stenosis or a single long lesion of ≥20mm OR multi-vessel CAD, defined as at least 2 vessels with ≥40% stenosis
- •Pre-PCI iFR performed in all vessels intended for PCI
- •Pre-PCI iFR of <0.90 of at least 1 stenosis
- •Subjects are able and willing to comply with scheduled visits and tests and to provide informed consent.
排除标准
- •Pregnant or planning to become pregnant for the duration of the study
- •Acute STEMI (ST-elevated Myocardial Infarction) within the past 7 days
- •Cardiogenic shock (sustained (>10 min) systolic blood pressure < 90 mmHg in absence of inotropic support or the presence of an intra-aortic balloon pump).
- •Ionotropic or temporary pacing requirement
- •Sustained ventricular arrhythmias
- •Prior CABG (Coronary Artery Bypass Graft)
- •Known ejection fraction ≤30%
- •Chronic Total Occlusion (CTO)
- •Known severe mitral or aortic stenosis.
- •Any known medical comorbidity resulting in life expectancy < 12 months.
- •Participation in any investigational study that has not yet reached its primary endpoint.
- •Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2).
- •TIMI flow <3 at baseline
- •Intra-coronary thrombus on baseline angiography
结局指标
主要结局
Number of Participants With Residual Ischemia (iFR <0.90)
时间窗: end of procedure/intervention
Residual ischemia is defined as iFR measurement \<0.90 after operator-assessed angiographically successful PCI (residual diameter stenosis \<50% in any treated lesion in the target vessel) This outcome describes the number of participants that had a residual ischemia (defined as iFR\<0.90) after a PCI that appeared to be successful based on angiography.
次要结局
- Target Vessel Revascularization(12 month)
- Differentiation(End of procedure /intervention)
- Delta iFR(at the end of the procedure/intervention)
- Target Vessel MI(12 month)
- Correlation Between iFR and Angiographic Visual Interpretation(at the end of the procedure/intervention)
- Target Vessel Failure(12 months)
- Quality of Life Change From Baseline to 12 Months Follow-up(12 months)
- Cardiac Mortality(12 months)
- Number of Participants in Which the iFR Would Become Non-significant if a Focal Stenosis Demonstrated by iFR Pullback Were Treated With PCI(Procedural)
- Cardiac Events(12 months)
- Recurrent Ischemia(12 month)