Late Incomplete Stent Apposition Evaluation II: Vascular Effects Evaluation After Polimer and No-polimer Based Coronary Artery Drug Eluting Stent Ilmplantation. An IVUS Based Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Intra coronary ultrasound analysis to verify stent malapposition at follow-up
研究概览
简要总结
Vascular effects evaluation after non-polimeric and polimeric paclitaxel stent implantation.In particular the investigators will use Taxus )as a polimeric stent)and Axxion (as a non-polimeirc)stent system. The investigators will look at late stent malapposition by means of intracoronary ultrasound imaging technique (IVUS) at baseline and 9 months follow-up. The investigators sought to compare the two stent types with the same drug to verify the polimer role. The polimer itself seems to provoke inflammation and hypersensibility if the arterial wall and it seems to be the base of a process of positive remodeling found at drug eluting stent implantation site.
This positive remodeling is the mechanism producing late stent malapposition which on its turn can determine stent thrombosis, as demonstrated by pathological studies. At the same time the investigators will study the incidence of clinical events like myocardial infarction, stent thrombosis, TLR and death along with the incidence of angiographic restenosis at 2 years follow up.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with coronary artery stenosis in one, two or three vessels, and with objective evidence of isquemia.
- •The stenosis must allow IVUS analisis, must be treatable with angioplasty with stent
- •Target Vessel diameter must be between 2.25- 4 mm with QCA.
- •Patients must sign informed consent
- •Patients and their physician must accept the angiographic follow-up
排除标准
- •18 years old patients
- •SCA within the last 72 hours, or patients with CK twice over the upper normal limit
- •Pregnancy
- •Target vessel diameter < 2.25 or > 4 mm by QCA
- •Previous brakitherapy or DES in the target lesion
- •Restenotic lesion
- •-Allergy to aspirin, clopidogrel or ticlopidin
- •Patients enrolled in other studies or trials
- •By-pass graft lesions
- •Real bifurcationa lesions
- •Severe Renal insufficiency (creatinin clearance < 30 ml/min).
- •Severe Liver failure(GOT y GPT > 3 times the upper normal limit)
- •Life expectancy < 1 year because of other pathologies
结局指标
主要结局
Intra coronary ultrasound analysis to verify stent malapposition at follow-up
时间窗: 9 months
次要结局
- Clinical events (myocardial infarction, TLR,at 1, 9, 12, 24 months follow-up:; Incidence of restenosis with QCA at 9 months follow-up Intimal hiperplasia measured by IVUS at 9 months follow-up; Stent Thrombosis.(9 months and 2 years)