NCT02060175撤回4 期
Comparison of the 3-month Strut Coverage After Coronary Stenting by Optical Coherence Tomography; Cilotax and DESyne
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Stent coverage
研究概览
简要总结
We will compare the stent coverage at 3 months by optical coherence tomography (OCT) between the Cilotax and DESyne drug-eluting stents (DES). The extent of the strut uncoverage has not been evaluated yet for both the Cilotax and DESyne and we first sought to decide the reference intervals using 40 samples (total 44 patients for each group considering 10% drop-out rate) as the pilot study.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 20 years old
- •Patients in the treatment of subjects with all-comer who are to undergo PCI
排除标准
- •Pregnant women or women with potential childbearing
- •Life expectancy < 1 year
研究组 & 干预措施
1 CILOTAX arm
Experimental
Cilotax drug-eluting stents implantation
干预措施: Cilotax drug-eluting stents implantation (Device)
2 DESyne arm
Active Comparator
DESyne drug-eluting stents implantation
干预措施: DESyne drug-eluting stents implantation (Device)
结局指标
主要结局
Stent coverage
时间窗: up to 3 months after stent implantation
The percentage of stent uncoverage measured by OCT
次要结局
未报告次要终点
研究者
相似试验
已完成
4 期
Optical Coherence Tomography Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery DiseaseCoronary Artery DiseaseNCT00704145A.O. Ospedale Papa Giovanni XXIII30
Unknown
不适用
Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary ObstructionBiliary Tract NeoplasmsNCT02255669Samsung Medical Center106
已完成
4 期
A Study Comparing Two Stent on the Degree of Early Stent Healing and Late Lumen Loss.The OCT-ORION StudyCoronary Artery DiseaseNCT01742507The University of Hong Kong60
已完成
不适用
6-month Intracoronary Optical Coherence Tomography (OCT) Evaluation of Three New Generation Drug Eluting StentRecurrent Angina After Coronary Stent PlacementNCT02850497Azienda Ospedaliero-Universitaria Careggi60
已完成
不适用
Prospective Comparison of Cirrus Versus Stratus Ocular Coherence Tomography for Different Retinal Pathology.Retinal PathologyNCT00731458University of Chicago60