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临床试验/NCT00738686
NCT00738686已完成4 期

Austrian Multivessel Taxus-Stent Registry

Medical University of Vienna7 个研究点 分布在 1 个国家目标入组 441 人开始时间: 2004年6月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
441
试验地点
7
主要终点
Incidence of MACCE, defined as all-cause death, nonfatal acute myocardial infarction (AMI) target vessel revascularization (TVR) and cerebrovascular event during the two-year clinical follow-up (FUP)

研究概览

简要总结

The aim of AUTAX study is to investigate the frequency of MACCE in patients with multivessel disease and multiple Taxus stent implantations in the "real world" stenting at 30 days, 6 and 12 months at 2 year follow-up. Because multivessel stenting using DES has been limited due to economic considerations, the secondary aim is to enhance experience in multivessel stenting with drug-eluting stents in order to improve short- and long-term outcomes of the patients with severe multiple coronary artery stenoses.

The objectives of the study are:

  1. To determine the frequency of MACCE at 30-day, 6 and 12-month and at 2 year clinical follow-up after multivessel intervention with drug-eluting stents in a prospective patient cohort..
  2. To determine the rate of in-stent restenosis, target lesion and target vessel revascularization (angiographic measures) 6 months in patients with multiple DESs in multiple lesions.
  3. To investigate the clinical and angiographic outcomes after implantation of multiple DESs in the subgroup of patients with accompanying diseases (diabetes mellitus, renal insufficiency) with known high restenosis and late complication rate.
  4. To evaluate potential cost burden in attempting a strategy of complete revascularization by multiple DES in patients with multivessel disease.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • symptomatic coronary multivessel disease
  • possible percutaneous complete coronary revascularization
  • age >18 year
  • significant coronary lesion at least in 2 vessels

排除标准

  • acute myocardial infarction within 48 hours
  • contraindications to clopidogrel, aspirin, heparin and taxol
  • pregnancy or lack of protection against pregnancy or breast-feeding during the study
  • hemorrhagic diathesis
  • platelet count <100.000/ml3

结局指标

主要结局

Incidence of MACCE, defined as all-cause death, nonfatal acute myocardial infarction (AMI) target vessel revascularization (TVR) and cerebrovascular event during the two-year clinical follow-up (FUP)

时间窗: 2 year

次要结局

  • Break-down primary endpoints at the 2-year FUP, as the rate of TVR, non-fatal AMI, all-cause death, stroke and the composite of death and AMI(2 year)
  • Incidence of 30-days, 6-mo and 1-year MACCE(1 year)
  • Acute, subacute and late thrombosis rates(2 year)
  • Angiographic end-points as the binary restenosis rate per lesion (defined as diameters stenosis ≥ 50%), in-stent and proximal and distal in-lesion late lumen loss(6-month)

研究者

申办方类型
Other

研究点 (7)

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