Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Tissue Coverage
研究概览
简要总结
Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.
详细描述
The first 20 patients enrolled will be evaluated by angiography and Optical Coherence Tomography 3 months after stent implantation. The following 20 patients will be evaluated by the same methods 2 months after the implantation and the last 20 patients after 30 days.
All patients will be clinically followed at 30 days, 6 months, 1 and 2 years after index procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤ 80years;
- •Symptomatic CAD or documented myocardial ischemic disease;
- •Up to 2 de novo lesions on native coronary arteries;
- •Lesion length ≤ 29mm;
- •Reference vessel diameter between ≥2.5 and ≤ 3.5 mm;
- •Stenose at target lesion ≥ 70% and ≤ 99%.
排除标准
- •STEMI within the last 72 hours pre-procedure;
- •renal insufficiency;
- •Left Main stenosis > 50%;
- •Ostial lesions;
- •Bifurcation lesions with side branch ≥2mm;
- •More than one lesion > 50% at the target vessel;
- •Left Ejection Fraction less than 30%;
- •Previous (less than 6 months) PCI at the target vessel.
研究组 & 干预措施
30 days evaluation
Angiography and Optical Coherence Tomography evaluations
干预措施: Angiography and Optical Coherence Tomography evaluations (Device)
2 months evaluation
Angiography and Optical Coherence Tomography evaluations
干预措施: Angiography and Optical Coherence Tomography evaluations (Device)
3 months evaluation
Angiography and Optical Coherence Tomography evaluations
干预措施: Angiography and Optical Coherence Tomography evaluations (Device)
结局指标
主要结局
Tissue Coverage
时间窗: 3 months
Change in the tissue coverage percentage measured by OCT
次要结局
- in-stent late lumen loss(3 months)
- Target Vessel Failure(2 years)
- Stent Thrombosis(2 years)