NCT03610347终止不适用
Study to Evaluate the Efficacy and Safety of Paclitaxel Eluting Balloon After Bare Metal Stent Implantation Versus Drug-eluting Stent in St Elevation Myocardial Infarction
Fundacion Investigacion Interhospitalaria Cardiovascular32 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2016年6月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 199
- 试验地点
- 32
- 主要终点
- Target Vessel Failure (TVF)
研究概览
简要总结
Study objective is the evaluation of safety and efficacy at 12 months of the combination treatment of bare metal Stent plus Paclitaxel Eluting Balloon vs drug eluting stent in patients with ST-elevation myocardial infarction with less than 12 hours of evolution.
详细描述
This is a multicenter, prospective, randomized, open study
After the permeabilization of the clinical event responsible artery patients will be randomized in a 1:1 ratio to one of the following treatment groups:
Group 1: insertion of a bare metal stent with post-dilatation with a paclitaxel eluting balloon (Pantera Lux ®)
Group 2: insertion of a drug elution stent
Patients (or their legal representative) must sign the consent before randomization.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged equal or older than 18 years.
- •Acute myocardial infarction (AMI) within 12 hours of evolution (from the onset of symptoms) systolic time elevation of at least 1 mm (recorded in two or more contiguous leads), new left bundle branch block, or true posterior infarction.
- •Patients candidates for primary angioplasty as medical criteria
- •Written informed consent according to International Conference on Harmonization / Guide Clinical Practice and local legislation, obtained before any study procedure.
- •Diameter vascular coronary artery to treat between 2 mm and 4 mm.
- •Patients with 85-100% stenosis and TIMI Score (Thrombolysis In Myocardial Infarction) of 0-I.
排除标准
- •Patients who refuse to participate in the study
- •Cardiogenic shock (defined as systolic blood pressure less than 80 mm Hg for more than 30 minutes or need for vasopressors or intra-aortic balloon counterpulsation)
- •Concomitant diseases associated with a life expectancy of less than one year
- •Angiographic variables:
- •Trunk unprotected
- •Branching (side branch greater than 2.5 mm)
- •Sinus tachycardia segment elevation myocardial infarction thrombosis secondary to stent
- •If more than one stent to treat a single segment (overlapping stents)
- •Patient candidate for surgical revascularization within 30 days
- •Stenosis of greater than 30 mm in length (corresponding with the ball longer available)
- •More severe stenosis in the same artery in which is expected to be addressed in the next 9 months
- •Women at childbearing age, where there is the possibility of pregnancy during the first year of follow-up, or nursing.
- •Any clinical condition, which in the opinion of the investigator, is considered clinically significant as to participate in the study.
- •Subjects who are participating in any study drug or medical.
- •Individuals who show inability to follow instructions or help during the course of the study.
- •Bleeding diathesis or other disorders such as gastrointestinal ulceration or cerebral circulatory disorders, restricting the use of treatments platelet aggregation inhibitors and anticoagulants.
- •Patients with an ejection fraction <30% (if known).
- •Allergy or hypersensitivity to paclitaxel intolerance, or compounds structurally related to the Butyryl tri-n-hexyl citrate (BTHC) matrix of administration.
- •Severe allergy to contrast media.
- •Coronary artery spasm in the absence of significant stenosis.
结局指标
主要结局
Target Vessel Failure (TVF)
时间窗: 1 year
Efficacy: TVF define as a the composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization
次要结局
- Target Lesion Revascularization (TLR)(1 year)
- Major Adverse Cardiac Events (MACE)(1 year)
研究者
Arturo García-Touchard
Principal Investigator
Fundacion Investigacion Interhospitalaria Cardiovascular
研究点 (32)
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