Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage I (ILUMIEN I)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 418
- 试验地点
- 36
- 主要终点
- Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
研究概览
简要总结
The purpose of this study is to define and evaluate optical coherence tomography (OCT) stent guidance parameters through prospective data collection in percutaneous coronary intervention (PCI) procedures of de novo lesions.
详细描述
Optical coherence tomography (OCT) is an imaging modality that uses near-infrared light to produce high resolution, real-time images that are clearer and more quickly produced than those produced by intravascular ultrasound (IVUS). OCT imaging is performed utilizing an imaging catheter with a single optical fiber core that both emits light and records its reflection while simultaneously rotating 360° during continuous pullback within the coronary artery. Fractional Flow Reserve (FFR) is a pressure-derived, lesion-specific, physiological index determining the hemodynamic severity of intracoronary lesions. FFR is measured by placing a pressure guidewire across the lesion of interest and pharmacologically inducing hyperemia. The ratio of distal to proximal pressure allows the physician to physiologically determine if the narrowing is the cause of ischemia. the goal of this study is to define new parameters for stent optimization, benefitting from the unique Fourier-domain (FD-OCT) capabilities.
This stage I study will identify the parameters which will be prospectively tested in a second stage II protocol.
In hospital, 30 day, and 12 month outcomes data will be correlated with OCT baseline findings in order to identify optimal stent implant parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age ≥ 18 years.
- •Patient provides signed written informed consent before any study-specific procedure.
- •De novo coronary artery disease in target vessel.
- •Single or multi vessel disease. For multi vessel disease up to two vessels and three lesions treated, with no more than two lesions per vessel. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel.
- •Elective or ad hoc PCI, stable angina, acute coronary syndrome (unstable angina and NSTEMI).
- •Angiographically significant (>50% visual estimation) stenosis present in at least one native coronary artery.
- •Mandatory use of FFR and OCT pre and post PCI. PCI strongly recommended in subjects with an FFR ≤ 0.80 in target vessel.
排除标准
- •Subjects with STEMI, emergent PCI, or in cardiogenic shock.
- •Subjects with target left main lesion.
- •Subjects with restenosis or stent thrombosis in the target vessel.
- •Planned use of bare metal stent.
- •Known renal insufficiency (examples being but not limited to eGFR < 60 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL, or on dialysis).
- •Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
- •Extreme angulation (> 90°) or excessive tortuosity (> two 45° angles) proximal to or within the target lesion.
- •Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease.
- •Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results.
- •Currently participating in another clinical study that interferes with study results.
- •Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
- •Life expectancy less than 1 year.
- •Potential for non-compliance to protocol requirements and follow-up.
- •Planned or prior heart transplantation or listed for heart transplant.
- •Any condition that precludes the subject from undergoing PCI, for example subjects with heparin induced thrombocytopenia, or contrast allergy.
结局指标
主要结局
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
时间窗: 30 Days
Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 30 days
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
时间窗: 12 months
Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 12 months
次要结局
- Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT(1 Year)