ISRCTN57874028已完成未知
Stent-protected Percutaneous Angioplasty of the Carotid artery versus Endarterectomy
Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF) (Germany)0 个研究点目标入组 1,900 人开始时间: 2005年8月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,900
研究概览
简要总结
- 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15178989 2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23237679 3. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30355202 4. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31378071 (added 06/08/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •a. Symptomatic (Amaurosis fugax, transient ischemic attack [TIA], prolonged reversible ischaemic neurologic deficit [PRIND], complete stroke), Stenosis of the carotid bifurcation or the internal carotid artery (ICA) within 180 days before randomisation
- •b. Clinical impairment not more than 3 of the modified Rankin scale
- •c. Age at least 50 years
- •d. Negative pregnancy test for women with childbearing potential
- •e. Possibility to participate on the follow-up visits
- •f. Written informed consent
- •g. Stenosis of the carotid bifurcation or the ICA on the clinically symptomatic side with at least 70% according the criteria of the European Carotid Surgery Trial (ECST) or at least 50% after the criteria of the NASCET
排除标准
- •a. Intracranial bleeding within the last 90 days before treatment
- •b. Uncontrolled hypertension
- •c. Proved intracranial vessel malformation (aneurysm or arteriovenous malformation [AVM])
- •d. Known cardiac cause of thromboembolism
- •e. Concomittant disease that will prevent the patient from attending follow up or known malignancy
- •f. Not correctable coagulation abnormality
- •g. Contraindication against Heparin, acetylsalicylic acid (ASA), Ticlopidine, or Clopidogrel
- •h. Contraindication against contrast medium
- •i. Occlusion of the common carotid artery (CCA) or ICA
- •j. Stenosis by an external compression (e.g. by tumour)
- •k. Stenosis caused by dissection
- •l. Restenosis after surgical or endovascular treatment
- •m. Radiation-induced stenosis
- •n. Fibromuscular dysplasia
- •o. Thrombusformation within the stenosis
- •p. Tandemstenosis if the distal stenosis is more severe than the proximal one
- •q. Planned simultaneous surgical procedures
研究者
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