跳至主要内容
临床试验/NL-OMON34545
NL-OMON34545招募中不适用

Drug-Eluting Balloon vs Conventional Balloon Pre-dilatation: An Open Randomized Trial in Acute Myocardial Infarction safety and efficacy of the Genous Bio-engineered R Stent* pre-dilated with paclitaxel-eluting balloon (Pantera®) versus the Genous Bio-engineered R Stent* pre-dilated with non drug eluting balloon in Patients undergoing PCI for ST-segment Elevation Myocardial Infarction - DEBORA2

Diagram B.V.0 个研究点目标入组 128 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
128

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • Males or females >= 18 years of age and <= 80 years with symptoms of AMI of more than 30 minutes but less than 24 hours
  • ST segment elevation of > 1 mV in 2 adjacent ECG leads, with cumulative ST segment deviation of 6 mm or more

排除标准

  • Women of child-bearing potential
  • Severe hepatic or renal disease
  • Previous participation in the study
  • Life expectancy of < 1 year
  • Factors making follow-up difficult
  • AMI pre-treated with thrombolysis
  • Patients who have previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies (HAMA)
  • Known sensitivity to aspirin, clopidogrel, or coumadin
  • Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
  • Unable to provide informed consent

研究者

发起方
Diagram B.V.

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