Evaluation of Effect of Co-registration Between Optical Coherence Tomography (OCT) and Coronary Angiography Onto OCT Guided Percutaneous Coronary Intervention (PCI)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Geographic miss
研究概览
简要总结
The purpose of this study is to determine whether co-registration of OCT and angiography reduce geographic miss defined as stent edge dissection or significant residual stenosis at stent edge after stent implantation during percutaneous coronary intervention.
详细描述
Background: When a stent fails to fully cover the lesion, it is termed "geographic miss" (GM). Optical coherence tomography (OCT) is an intracoronary imaging modality that has higher resolution than conventional intracoronary ultrasound. Although OCT allows identification of the location of the culprit lesion and side branch using automated measures, it is sometimes difficult to identify the exact segment corresponding to angiography. Recently, co-registration of OCT and angiography has become available; however, whether this reduces the incidence of GM during stenting is unknown.
Hypothesis: OCT reduces GM during percutaneous coronary intervention.
Objectives:
- Determine the incidence of GM defined as residual disease* and significant edge dissection† at proximal and distal reference
- Determine the incidence of stent dislocation (distance between planned and actual stented place)
- Determine procedural findings (additional stent, total fluoro time, total contrast volume)
- Minimum lumen area <4.0 mm2 in the presence of significant residual plaque within 5 mm distal and proximal to the stent edge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Patients ≥18 years old who undergo percutaneous coronary intervention per clinical indications.
排除标准
- •Left main disease
- •Ostial lesion at Right Coronary Artery
- •Tortuous artery in which OCT is unable to pass
- •Lesion at bypass graft
- •In-stent restenosis
- •Chronic total occlusion
- •Cardiogenic shock (sustained [>10 min] systolic blood pressure <90 mm Hg in absence of inotropic support or the presence of an intra-aortic balloon pump)
- •Acute phase heart failure
- •Sustained ventricular arrhythmias
- •Known ejection fraction <35%
- •Known severe valvular heart disease Known severe renal insufficiency (estimated glomerular filtration rate <30 mL/min/1.72 m2)
研究组 & 干预措施
Coronary PCI with OCT with Co-Registration
Coronary stenting will be performed with OCT guidance as per local practice. Pre and post stenting procedure will be performed with OCT guidance with the use of the Co-Registration software tool after stent implanted.
干预措施: Coronary PCI with OCT with Co Registration (Procedure)
Coronary PCI with OCT without Co-Registration
Coronary stenting will be performed with OCT guidance as per local practice. Pre and post stenting procedure will be performed with OCT guidance without the use of the Co-Registration software tool after stent implanted.
I
干预措施: Coronary PCI with OCT without Co Registration (Procedure)
结局指标
主要结局
Geographic miss
时间窗: Intraoperative
Geographic miss defined as evidence of residual disease at stent edge or significant edge dissection after stent deployment
次要结局
- Number of additional stents required(Intraoperative)
- Total fluoroscopy time(intraoperative)
- Number of participants with Residual disease at stented edge(Intraoperative)
- Distance between the planned and actual stent location(Intraoperative)
- Number of participants with stent edge dissection(peri procedure)
- Procedure time(Intraoperative)
- Total contrast volume(intraoperative)
研究者
Richard A. Shlofmitz, MD
Chairman of Cardiology- Principal Investigator
St. Francis Hospital, New York