NCT02932995Unknown不适用
Evaluation of DUAL Drug-eluting Stent ( DXR Stent) for Vascular Healing and Thrombus Formation : an Optical Coherence Tomography Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Stent strut coverage (Incidence of uncovered strut)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a novel dual drug-eluting stent (DXR stent), which slowly releases both cilostazol and paclitaxel, for strut coverage, malapposition, and thrombus formation, assessed by an optical coherence tomography.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=19 years
- •Clinically indicated to invasive coronary angiography
- •Patient capable and willing of giving written informed consent
- •Angiographic
- •coronary artery disease confined to native coronary artery
- •>50% diameter stenosis by invasive coronary angiography
- •reference diameter 2.5-4.0mm, lesion length ≤30 mm
排除标准
- •Inability to provide written informed consent
- •Serious comorbidity which may affect the trial by decision of investigators
- •Prior CABG to target vessel
- •Congestive heart failure with NYHA Class III or IV or left ventricular ejection fraction less than 30%
- •Prior ST elevation myocardial infarction within 72 hours from the procedure
- •Hemodynamic or electrical instability including shock
- •Serious coronary artery spasm, unrelated to catheter
- •Pregnancy or possible pregnant status
- •Allergy to iodinated contrast agent
- •Serum creatinine >=1.7 mg/dL or creatinine clearance <= 30 ml/min
- •ST elevation myocardial infarction
- •Angiographic (OCT)
- •Left main disease
- •Severely calcified lesion
- •Severely tortuous, or TIMI flow grade 0 or 1 by angiography, or inappropriate for OCT procedure by investigators' decision
结局指标
主要结局
Stent strut coverage (Incidence of uncovered strut)
时间窗: 6 month
Coronary angiography with OCT follow up
次要结局
- Stent malapposition(6 month)
- Stent thrombosis(6 month)
研究者
Sang-Wook Kim
Professor
Chung-Ang University
研究点 (6)
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