Prospective, Single-center, Randomized Trial, Intended to Compare of Intravascular Ultrasound and Optical Coherence Tomography Guided Implantation of Different Drug-eluting Stents and Implantation Without Using of Intravascular Visualization
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- MACCE
研究概览
简要总结
The objective of this research is to assess the clinical results of implantation of different drug eluting stents under "aggressive" intravascular ultrasound (IVUS) guided all the way up to 24 months after operation and to establish the significance of the data of an optical coherent tomography (OCT) for the assessment of direct results of stenting and the degrees of endothelization of stent after 6 months.
The following hypothesis formed the base for this study:
- IVUS guided intervention allows to improve the results and increase the safety of implantation drug eluting stents.
- Suboptimal results according to IVUS data can influence the follow up results of treatment.
- Suboptimal results according to OCT data, which are not revealed by IVUS, can influence the follow up results of treatment.
- The use of strategy of stenting with the achievement of optimal results under the intravascular methods of visualization allows to reduce the time of application of antiplatelet therapy.
- The modern limus-eluting stents do not differ in the follow up results in investigated criteria.
详细描述
1000 consecutive patients are planned to be included who will underwent endovascular treatment answering for the inclusion criteria and having given informed consent to the inclusion in the study.
Criteria for choosing the size of the stent according to the IVUS:
- Support on the healthy parts of the vessel.
- The diameter of the stent should match the diameter of "media-media" in the distal reference segment or be the average between the diameter of the lumen of the proximal and distal reference segments.
- Postdilatation is sure to be in the stent: in the affected area by a large balloon over the initial diameter of the "media-media", at the entrance of the stent - over the initial of the reference diameter of the lumen.
After postdilatation a control is being performed with "Virtual Histology" (VH) IVUS and i-MAP, an optimal stent implantation is estimated.
Criteria for optimal implantation:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •de novo lesion,
- •the diameter of a vessel is not less than 2,75 mm,
- •the length of lesion not more than 60 mm,
- •stenosis is more than 60 %,
- •possibility of a covering by no more than 2 stents,
- •there is no need in stenting of side branch (including left main coronary artery).
排除标准
- •in-stent restenosis,
- •saphenous vein grafts,
- •the diameter of a vessel is less than 2,75 mm,
- •the length of lesion more than 60 mm,
- •there is a need in stenting of side branch (including left main coronary artery),
- •impossibility of long antiplatelet therapy,
- •impossibility of an appearance for control research
结局指标
主要结局
MACCE
时间窗: Two years
Major adverse cardiac and cerebral events (MACCE), including death, a composite of major cardiac and cerebrovascular events, i.e. the first occurence of any of the following events: Death from any cause - From cardiovascular causes, From noncardiovascular causes; Stroke or transitory ischemic attack (TIA), Myocardial infarction (MI), Hospitalization for repeat revascularization procedure, target vessel revascularization by means of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
次要结局
- Neo-Intimal Plaque Volume and Area(6 months, 2 years)
- Uncovered struts of stents(6 months, 2 years)
- Restenosis(6 months, two years)
- In stent lumen late loss(6 months, 2 years)
- Stent Malapposition(6 months, 2 year)