The Drift-Reduction for Improved Fractional Flow Reserve (FFR) Using Fiberoptic Technology (DRIFT) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Percentage of Recordings of Significant Drift in Pre and Post-PCI
研究概览
简要总结
The primary objective of this study is to assess the accuracy, efficacy, and durability of the OpSens Medical OptoWire Deux pressure wire in the assessment of angiographically intermediate proximal left anterior descending coronary artery (LAD) stenoses in clinical practice.
详细描述
This study is designed as a prospective, observational in nature, multi-center, single-arm, clinical registry to estimate the ischemic burden of angiographically intermediate proximal LAD stenosis in clinical practice using the OpSens Medical OptoWire Deux FFR system. Subjects with stable angina or unstable angina who are found to have an intermediate proximal LAD stenosis on coronary angiography with anatomy amenable to PCI and underwent physiological lesion assessment with the OptoWire Deux pressure wire and OCT as part of their routine procedures using standard of care techniques will be enrolled. Patients meeting enrollment criteria will be offered the opportunity to enroll in this observational registry post-procedure. All patients enrolled in this study are expected to be evaluated and treated using a standard of care technique. This study will enroll a total of 60 patients at Columbia University Medical Center and St. Francis Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Male or female subjects, >18 years of age.
- •Patients with stable angina, unstable angina or non-ST segment elevation myocardial infarction (if the LAD lesion is the non-culprit lesion) and in whom an intermediate proximal LAD de novo stenosis (30-80%) with TIMI flow 3 has been identified on angiography. Note: Patients with multi-vessel disease can be enrolled.
- •Patients have had fractional flow reserve (FFR) and optical coherence tomography (OCT) of the LAD with the OpSens FFR system as part of their routine evaluation as standard of care procedure.
- •Provides written, informed consent and HIPAA consent to use the data in a clinical study.
排除标准
- •(General exclusion criteria)
- •Patients presented with NSTEMI with the LAD involved as the culprit lesion
- •Any ST-elevation myocardial infarction within the past 30 days.
- •Hemodynamic instability requiring vasopressor or mechanical circulatory support.
- •Prior heart transplant.
- •Known left ventricular ejection fraction ≤40%.
- •LAD supplying akinetic or severely hypokinetic territories if already known based on prior imaging.
- •Patient is enrolled in another clinical study that may impact the results of this study.
- •FFR not acquired per instructions for the OpSens Wire.
- •LAD Lesion not assessed with OCT.
- •(Angiographic exclusion criteria)
- •Thrombolysis in Myocardial Infarction (TIMI) grade 2 or lower at baseline angiography.
- •Target lesion involves left main (stenosis >50%).
- •Previous percutaneous coronary intervention (PCI) with stent in LAD or left main trunk.
- •Presence of chronic total occlusion in any vessel.
- •Presence of a side branch≥2.75 mm with ≥70% stenosis in the LAD.
- •Bifurcation lesion that resulted in the stent implantation of a side branch.
结局指标
主要结局
Percentage of Recordings of Significant Drift in Pre and Post-PCI
时间窗: During procedure, approximately less than an hour
The rate of significant drift is defined as FFR \<0.97 or \>1.03 with the in the pre-percutaneous coronary intervention (PCI) FFR recording using the OpSens OptoWire Deux pressure wire system. FFR is calculated by measuring the ratio between pressure distal to a stenosis and pressure proximally to stenosis using specialized pressure-measuring guidewires during maximal hyperemia.
次要结局
未报告次要终点