Vessel Injury in Relation With Strut Thickness Assessed by OCT (VISTA): A Comparison of Vascular Injury Induced by a Polymer Free Sirolimus and Probucol Eluting Stent and a Biodegradable-polymer Biolimus-eluting Stent
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- OCT-based intimal injury score
研究概览
简要总结
The objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness.
详细描述
Thinner struts produce less arterial injury after stent implantation.The objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness. Vessel injury after stent implantation will be evaluated with optical coherence tomography (OCT). Two stents platforms with different strut thickness (Coroflex ISAR 50 microns and Biomatrix 120 microns) will be compared.
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
- Single (Outcomes Assessor)
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 older than 18 years
- •Ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of >50% de novo stenosis located in native coronary vessels
排除标准
- •Target lesion located in the left main stem
- •Restenosis
- •Cardiogenic shock
- •Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol noncompliance
- •Known allergy to the study medications (probucol, sirolimus, zotarolimus)
- •Pregnancy (present, suspected, or planned)
研究组 & 干预措施
Coroflex ISAR stent
PCI with a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR stent) with very thin struts (50 µm). During the PCI, an OCT assessment (baseline and post-implantation) will be performed.
干预措施: Polymer-free stent (Device)
Biomatrix stent
PCI with a biodegradable-polymer biolimus-eluting stent (Biomatrix stent) with 120 µm struts. During the PCI, an OCT assessment (baseline and post-implantation) will be performed.
干预措施: Biodegradable-polymer stent (Device)
结局指标
主要结局
OCT-based intimal injury score
时间窗: Up to 1 day (evaluated after stent implantation)
OCT-based intimal injury score estimated after implantation of the Coroflex-ISAR and Biomatrix DES
次要结局
- Incidence of stent malapposition(Up to 1 day (evaluated after stent implantation))
- Incidence of stent underexpansion(Up to 1 day (evaluated after stent implantation))
- Tissue prolapse area(Up to 1 day (evaluated after stent implantation))
- Stent symmetry after implantation(Up to 1 day (evaluated after stent implantation))
- Baseline plaque type(Up to 1 day (evaluated after stent implantation))
研究者
Nieves Gonzalo
MD, PhD
Hospital San Carlos, Madrid