On-line 3-dimensional Optical Frequency Domain Imaging to Optimize Bifurcation Stenting Using UltiMaster Stent: OPTIMUM Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 106
- 试验地点
- 4
- 主要终点
- Percentage of malapposed struts
研究概览
简要总结
The primary purpose of this study is to determine whether bifurcation stenting guided by on-line three-dimensional optical frequency domain imaging (3D-OFDI) is superior to that with angiographic guidance by measuring incomplete stent apposition (ISA) in the bifurcation segment.
详细描述
The recently developed optical frequency domain imaging (OFDI) can provide high quality resolution images of the coronary arteries. This new imaging system enhances the understanding of complex coronary lesions and the complex interaction between coronary devices and vessels by assembling/compiling 2-dimensional cross sections.
This 3-dimensional reconstruction with strut segmentation becomes possible on-line in the TERUMO OFDI console with 3-dimensional imaging software, which enables stent enhancement and 3D reconstruction within one minute. This "real time" 3D OFDI will promote the utilisation of 3-dimensional assessment in the treatment of bifurcation lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patient is at least 18 years of age and signed Informed Consent
- •Subject has coronary artery disease involving a bifurcation with objective evidence of ischemia including patients with chronic stable angina, silent ischemia and non-ST segment elevation acute coronary syndrome (NSTE-ACS)
- •Subject is appropriate to be treated by PCI according to the local practice (operator's judgment or heart team decision)
- •Patients' residence is in the area covered by the hospital
- •Patients with angiographically significant stenosis (>50 % by visual assessment) in de novo, native, previously unstented bifurcation lesion(s) including left main lesion, which is in operator's opinion appropriate to be treated by PCI with a single stent strategy
- •The size of main vessel matches available Ultimaster stent sizes (<4.0 mm, and 2.0 mm by visual assessment)
- •The size of side branch is >2.0mm in diameter by visual assessment
- •The sidebranch is treatable with a sidebranch fenestration and/or kissing balloon
排除标准
- •Patients with ST elevation myocardial infarction
- •Known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, sirolimus, contrast material
- •Known thrombocytopenia (platelet count< 100,000/mm3)
- •Cardiogenic Shock
- •Significant comorbidities precluding clinical follow-up (as judged by investigators)
- •Major planned surgery that requires discontinuation of dual antiplatelet therapy
- •History of stenting in the target bifurcation lesion
- •Renal insufficiency (GFR/MDRD <45 ml/min), which precludes in operator's opinion contrast injection during repeat OFDI pullback
- •Severely tortuous or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal optical frequency domain imaging (OFDI) or excessive risk of complication to place an OFDI catheter
- •Target lesion reference vessel diameter (RVD) < 2.25 and > 4 mm
- •Other: Patient is judged inappropriate by the attending physician
结局指标
主要结局
Percentage of malapposed struts
时间窗: at time of bifurcation PCI surgery
Percentage of malapposed struts assessed by OFDI in bifurcation segment of main vessel
次要结局
- Maximum protrusion area (mm²)(at time of bifurcation PCI surgery)
- Incomplete stent apposition (ISA) area (mm²)(at time of bifurcation PCI surgery)
- Minimum lumen area (mm²)(at time of bifurcation PCI surgery)
- Incidence of fulfilling optimal recrossing criteria on 3D-OFDI(at time of bifurcation PCI surgery)
- Mean stent area (mm²)(at time of bifurcation PCI surgery)
- Mean lumen area (mm²)(at time of bifurcation PCI surgery)
- Minimum stent area (mm²)(at time of bifurcation PCI surgery)
- Mean protrusion area (mm²)(at time of bifurcation PCI surgery)
- Minimum flow area (mm²)(at time of bifurcation PCI surgery)
- Mean flow area (mm²)(at time of bifurcation PCI surgery)