Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- OCT-measured in-scaffold minimal lumen area
研究概览
简要总结
The primary objective is to determine whether IVUS- (vs. OCT-) guided BVS implantation is non-inferior to achieve a large in-scaffold minimal lumen area (primary endpoint) measured by OCT at 1-year follow-up.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 years or older
- •Patients who have at least one epicardial coronary artery lesion with an evidence of inducible ischemia
- •Willing and able to provide informed written consent
- •Eligible for PCI
排除标准
- •Patients presenting with STEMI within 2 weeks
- •Bypass graft lesion
- •Lesion with left main disease
- •Expected length of scaffold > 40 mm
- •Bifurcation lesion requiring side branch stenting
- •Small vessels < 2.75 mm
- •Stented lesion
- •Suspected coronary spasm even after sufficient nitrate injected
- •Cases in which the IVUS or OCT imaging catheter failed to cross the lesion
- •Poor quality IVUS or OCT images
- •Contraindication to dual anti-platelet therapy
- •Chronic total occlusion
- •Angiographically large-sized vessel (>3.5mm of reference lumen diameter)
- •Life expectancy shorter than 2 years
- •Pregnancy
研究组 & 干预措施
Optical coherent tomography
Optical coherent tomography provides more detailed information about the morphology of scaffolds, microstructures and coronary vasculature based on tissue characteristics as compared to conventional IVUS. In spite of angiographic success in BVS placement, further scaffold optimization was required in over a quarter of cases based on OCT findings due to malapposition or scaffold under expansion.
干预措施: Optical coherent tomography (Other)
IntraVascular UltraSound
Intravascular ultrasound guidance has been associated with improved event-free survival compared with angiographic guidance after DES placement.
干预措施: IntraVascular UltraSound (Other)
结局指标
主要结局
OCT-measured in-scaffold minimal lumen area
时间窗: 1 year
次要结局
- OCT-measured minimal scaffold area (MSA)(1 year)
- OCT-measured mean scaffold expansion(1 year)
研究者
Young-Hak Kim, MD, PhD
Professor in medicine
Asan Medical Center