ORBID Trial: Three-Dimensional (3D) Optical Coherence Tomography Guided Assessment of Side Branch Vessel After Provisional Main Vessel Stenting in Coronary Artery Stenting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- MLD SB Diameter
研究概览
简要总结
This is a prospective study to analyze the outcome of provisional main vessel stenting on side branch by utilizing Two-Dimensional (2D) and Three-Dimensional (3D) frequency domain optical coherence tomography (FD-OCT). To analyze the fate of side-branch after provisional main vessel stenting based on morphology defined prior to PCI by OCT. Offline analysis of side branch impingement of the ostium of SB leading to acute loss in SB diameter area, carina shift and plaque shift will be also be performed.
详细描述
Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned will be recruited. All the participants of the registry will receive same stent. OCT will be performed to analyze plaque morphology, SB size, SB angle and side branch ostial involvement.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age presenting with stable coronary artery disease.
- •Angiographic lesion not involving side branch (SB) in whom provisional main vessel stenting strategy is planned after reviewing angiogram will be recruited
排除标准
- •Patient with lesion involving side branch ( >70 %) by angiogram and need pre-dilation.
- •Patients with ostial left main artery lesions or ostial right coronary artery lesions
- •Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding
- •Known allergy to acetylsalicylic acid or clopidogrel.
- •Planned surgery within 12 months.
- •History of bleeding diathesis
- •Major surgery within 15 days
- •Life expectancy < 12 months.
- •Patients with kidney dysfunction (CrCl<30)
结局指标
主要结局
MLD SB Diameter
时间窗: day 1
Optical coherence tomography (OCT) - a high resolution intravascular imaging technique to assess side branch size. Side branch diameter will be measured by QAngio OCT software from Medis. Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Main vessel minimal lumen diameter (MLD)
次要结局
- SB Angle(day 1)
- SB Ostial Involvement(day 1)
- Diameter Stenosis (DS)(day 1)
研究者
Annapoorna Kini
Professor, Medicine
Icahn School of Medicine at Mount Sinai