NCT02528474终止不适用
Comparison of Optical Coherence Tomographic Findings After Balloon Angioplasty With Two Different Paclitaxel-Coated Balloons for the Treatment of In-Stent Restenosis in Drug-Eluting Stents
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Neointimal thickness & area
研究概览
简要总结
Drug-coated balloon technology (DCB) has recently attracted considerable interest as a promising alternative treatment option, particularly in the setting of in-stent restenosis (ISR). Optical coherence tomographic finding of restenosis lesions in drug-eluting stents (DESs) after Balloon Angioplasty with Two Different Paclitaxel-Coated Balloons will be compared between two paclitaxel-coated balloon devices; Pantera Lux™ and SeQuent® Please.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 19 years old
- •Patients eligible for percutaneous coronary intervention
- •Single or more lesion(s) of restenosis requiring angioplasty in drug-eluting stent
- •Reference vessel diameter of target lesion ≥2.5 mm
排除标准
- •Cardiogenic shock
- •Bifurcation lesion or totally occluded lesion
- •Unprotected left main trunk lesion
- •Allergies or hypersensitivities to antiplatelet, anticoagulation therapy, contrast media, or paclitaxel
- •Heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesions
- •Pregnant women or women with potential childbearing
- •Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
- •Inability to understand or read the informed content
结局指标
主要结局
Neointimal thickness & area
时间窗: 9 months
measured by OCT analysis
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
不适用
D-OCT for Detection and Subtyping of BCC: a Diagnostic Cohort StudyOptical Coherence TomographyBasal Cell CarcinomaNCT06273722Maastricht University Medical Center424
已完成
不适用
CEI Van Outreach Screening StudyGlaucomaMacular DiseaseKeratoconusNCT01510392Oregon Health and Science University118
Unknown
不适用
Optical Tomographic Scanner for Skin LesionsSkin Cancer, Benign Skin Tumor, Inflammatory Skin DiseaseNCT02891291National Taiwan University Hospital300
已完成
不适用
Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior EyeFuch's DystrophyCorneal DisordersPrior SurgeryNCT00343473NYU Langone Health22
已完成
不适用
Early Feasibility Study: Application of OCT Imaging in DermatologySkin DiseasesNCT04066582Mackay Memorial Hospital123