Randomized, Controlled, Open-label, Double-blind, Multicenter Investigation Plan to Evaluate Early Endothelialization of a Polymer Free Sirolimus-eluting Coronary Stent System (VIVO ISARTM) Compared With Everolimus-eluting Durable Polymer Stent (XIENCE SkypointTM) in Patients Undergoing Percutaneous Coronary Intervention.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Percentage of early Covered struts (≥ 20μm) at 1 month OCT after stent implantation
研究概览
简要总结
To evaluate the stent endothelialization (> 20 microns) of VIVO ISARTM versus XIENCE SkypointTM stents at 1-month (very early strut covered) at follow-up by Optical Coherence Tomography (OCT) implanted IN THE SAME PATIENT during routine clinical practice.
详细描述
To evaluate the stent endothelialization (> 20 microns) of VIVO ISARTM versus XIENCE SkypointTM stents at 1-month (very early strut covered) at follow-up by Optical Coherence Tomography (OCT) implanted IN THE SAME PATIENT during routine clinical practice.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age ≥ 18 years AND
- •Patients who have signed informed consent AND
- •Patients with coronary artery disease requiring percutaneous treatment with coronary stents due to de novo lesions in vessels with a diameter of reference from 2.25 mm to 4.0 mm AND
- •Patients with at least 2 angiographic lesions in 2 different major coronary arteries. Or in the main branch and in one of its subsidiaries branches , as long as those are not "downstream" of the lesion from the main branch
排除标准
- •Express refusal of the patient to participate in the study
- •Patients with ST elevation Myocardial Infarction or Cardiogenic Shock
- •Patients with high thrombotic content
- •Pregnant or breastfeeding patients
- •Patients with complex PCI (Percutaneous Coronary Intervention )(defined as):
- •Left main PC
- •Chronic total PC occlusion
- •Bifurcation lesion requiring 2-stent technique .
- •Severe calcified lesion (need to use prior complex techniques of calcium modification such as intravascular lithotripsy, rotational/orbital atherectomy, laser.
- •Patients with malignant neoplasms or other comorbid conditions with life expectancy <12 months
- •Patients with a target lesion in a bypass graft
- •Lesions due to restenosis
- •Patients with PCI in the target vessel in the previous 9 months
- •Patients with contraindication or difficulty to evaluate in the follow-up with OCT (renal failure, excessive tortuosity or lesions aorto-ostial)
研究组 & 干预措施
XIENCE Skypoint DES in the first lesion
干预措施: XIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion (Device)
VIVO ISAR DES in the first lesion
干预措施: VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion (Device)
结局指标
主要结局
Percentage of early Covered struts (≥ 20μm) at 1 month OCT after stent implantation
时间窗: 1 month
Percentage of early Covered struts (≥ 20μm) at 1 month OCT after stent implantation
Percentage of stents with uncovered struts at 1 month OCT after stent implantation
时间窗: 1 month
Percentage of stents with uncovered struts (0μm) at 1 month OCT after stent implantation
Mean thickness of struts tissue coverage at 1 month OCT after stent implantation
时间窗: 1 month
Mean thickness of struts tissue coverage at 1 month OCT after stent implantation
次要结局
- Neointimal Healing Score (NHC) by OCT at 1 month(1 months)
- Percentage of malapposed total struts at 1 month(1 month)
- Percentage of malapposed scaffold struts over side branch at 1 month(1 month)
- Percentage of malapposition of stent at 1 month OCT after stent implantation(1 month)
- All-Cause Death Rate at 6 months(6 months)
- Cardiac Death Rate at 6 months(6 months)
- Target vessel revascularization Rate at 6 months(6 months)
- Percentage of covered struts at 1 months OCT after stent implantation(1 month)
- Myocardial Infarction Rate at 6 months(6 months)