NCT01637012已完成4 期
Prospective, Single-arm, Multicenter Study for Evaluation the Safety and Effectiveness of the ALEX Stent in a Real-world Setting of Percutaneous Coronary Interventions in Patients With Coronary Heart Disease. Study With Angiography and OCT Follow-up.
Balton Sp.zo.o.10 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Assessment of stent strut coverage and parameters of restenosis
研究概览
简要总结
To evaluate the safety and effectiveness of the ALEX stent in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease.
详细描述
Prospective, multicenter, non-randomized study designed to enroll up to 60 subjects to evaluate the safety and effectiveness of the cobalt-chromium sirolimus eluting coronary stent ALEX in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Clinical Inclusion Criteria:
- •> 18 years of age
- •Patient must provide written informed consent prior to procedure using a form that is approved by the local Ethics Committee
- •clinical diagnosis of Stable Angina, Unstable Angina or Myocardial Infarction without ST elevation (NSTEMI) or Myocardial Infarction with ST elevation provided the expiry of 72 hours of the onset of symptoms and stable clinical and hemodynamical condition the Patient with patent postinfarcion artery (TIMI 3) and indications for PCI and next stage of revascularization in the other vessels
- •earlier effective supply of others lesions in others vessels in case of multivessels disease
- •female of childbearing potential must have a negative pregnancy test within 7 days prior to enrolment and utilize reliable birth control for 12 months after enrolment
- •Angiographic Inclusion Criteria
- •target lesion stentosis must be > 70% (visual estimate)
- •Patient eligible for PCI treatment with the ALEX stent system (vessel diameter in range of 2.5 to 4.0 mm and length of lesion that allows to cover a single stent with maximum length of 30 mm in visual evaluation)
排除标准
- •Clinical Exclusion Criteria
- •anticipated inablility of the patient to comply with 12 months of antiplatelet treatment (e. g. elective non-cardiac surgery following stenting, drug intolerance etc.)
- •acute or chronic renal failure (serum creatinine > 2 mg%, GFR < 60 ml/min/1.73m2)
- •left ventricular ejection fraction (LVEF) < 40%
- •cardiogenic shock
- •short life expectancy (< 1 year)
- •any significant medical condition which in the investigator's opinion may interference with the Patient's optimal participation in the study
- •current participation in another drug or device clinical trail in which there no be reached the primary endpoint or which clinically interferences with trail's enpoints
- •Angiographic Exclusion Criteria
- •chronic total occlusion
- •calcified lesion which cannot be successfully dilated
- •location of lesions in the winding vessels where there is no possibility of OCT imaging
- •target stenosis located in venous or arterial bridge
- •unprotected left main coronary disease with > 50% stenosis
研究组 & 干预措施
ALEX stent arm
Experimental
implantation of ALEX stent during index procedure
干预措施: Implantation (Procedure)
结局指标
主要结局
Assessment of stent strut coverage and parameters of restenosis
时间窗: at 3 months follow-up
Assessment of stent strut coverage and parameters of restenosis in coronary angiography (QCA - Late Lumen Loss) and in OCT (percent of neointimal volume) at 3 months follow-up after the baseline procedure in group of third 20 patients
次要结局
- Occurrence of stent thrombosis(at 12 months follow-up)
- Incidence of Major Adverse Cardiac Events(at 12 months follow-up)
- Procedural success(during index hospitalization)
研究者
研究点 (10)
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