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临床试验/NCT00275990
NCT00275990已完成4 期

AngioJET Rheolytic Thrombectomy Before Direct Infarct Artery STENTing in Patients Undergoing Primary PCI for Acute Myocardial Infarction: [JETSTENT] Study

Boston Scientific Corporation1 个研究点 分布在 1 个国家目标入组 501 人开始时间: 2005年12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
501
试验地点
1
主要终点
ST-segment resolution at 30 minutes post-PCI, assessed by 12-lead ECG

研究概览

简要总结

The purpose of this study is to determine whether prompt removal of thrombus (blood clot) from a blocked coronary artery using the AngioJet rheolytic thrombectomy device will result in improved blood flow within the heart and a smaller final infarct size (reduced injury to the heart muscle).

详细描述

Occlusive thrombosis triggered by a disrupted or eroded atherosclerotic plaque is the anatomic substrate of most acute myocardial infarctions (AMI). Macro- and microembolization of thrombus during percutaneous coronary intervention (PCI) in AMI is frequent and may result in obstruction of the microvessel network, and decreased efficacy of reperfusion and myocardial salvage. Direct stenting without predilation or postdilation is the most simplistic approach to the problem of embolization, and may decrease embolization and the incidence of the no-reflow phenomenon. Other approaches to the problem of microvessel embolization include percutaneous rheolytic thrombectomy (RT) with the AngioJet catheter before stent implantation. The objectives of the study are: to assess whether RT before direct infarct artery stenting results in improved reperfusion success in patients with acute ST-segment elevation myocardial infarction (STEMI) and angiographically evident thrombus; and to validate a technique for use of the AngioJet RT catheter in the treatment of STEMI.

Comparisons: Treatment with AngioJet RT immediately before direct infarct artery stenting versus direct stenting alone, in patients with STEMI and angiographically visible thrombus presenting within 6 hours of symptom onset for primary PCI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
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

入选标准

  • Patient age > 18 years
  • ST-segment elevation myocardial infarction
  • Angiographically visible thrombus
  • Presentation within 6 hours of symptom onset for primary percutaneous coronary intervention
  • Patient, or relative or legal guardian,provides written informed consent
  • Patient has no childbearing potential or is not pregnant

排除标准

  • Prior administration of thrombolysis for current MI
  • Participation in another Study
  • Major surgery within past 6 weeks
  • History of stroke within 30 days, or any history of hemorrhagic stroke
  • Severe hypertension (systolic BP > 200 mm Hg or diastolic BP > 110 mm Hg) not controlled on antihypertensive therapy
  • Known neutropenia ( <1000 neutrophils per mm3) or known severe thrombocytopenia (< 50,000 platelets per mm3)
  • Known prior history of renal insufficiency
  • Co-morbidities with expected survival < 1 year
  • Patient unwilling to receive blood products

结局指标

主要结局

ST-segment resolution at 30 minutes post-PCI, assessed by 12-lead ECG

时间窗: 30 minutes post procedure

Infarction size measured by technetium Tc 99m sestamibi imaging at 30 days

时间窗: 30 days post-procedure

次要结局

  • 12 months- MACE(12 months post-procedure)
  • Post-procedure- TIMI flow, TIMI myocardial blush, and corrected TIMI frame count(post-procedure)
  • 6 months- MACE(6 months post-procedure)
  • 30 days- Technetium Tc 99m sestamibi infarct size, MACE(30 days post-procedure)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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