ISRCTN82823121已完成不适用
An international, multicentre prospective single arm study to investigate procedural, clinical and angiographic outcomes using the Taxus Liberte stent, with improved side branch access, following the provisional side branch T-stenting approach, in patients with complex lesions
ew Nantes Private Clinics (Nouvelles Cliniques Nantaises) (France)0 个研究点目标入组 400 人开始时间: 2007年2月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
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
入选标准
- •1. Patients with stable angina pectoris (CCSC1234) or unstable angina and documented ischaemia or silent ischaemia
- •2. Patient eligible for coronary revascularisation
- •3. The target lesion has a major native coronary artery (more than 2.5 mm) with a stenosis more than 50% (on visual assessment) located at a side branch (more than 2 mm)
- •4. A de novo lesion
- •5. All angle severities (between branches) accepted
- •6. The main vessel lesion can be covered by one stent (up to 32 mm)
- •7. Other lesions in different vessels are successfully treated before the treatment of the target lesion (residual stenosis less than 30%, stent well deployed, no residual dissection, normal Thrombolysis in Myocardial Infarction [TIMI] flow, no chest pain, ElectroCardioGram [ECG] unchanged compared to pre-procedural ECG)
- •8. Only one target lesion can be included in the study
- •9. Signed patients informed consent
排除标准
- •1. Patients with in stent restenosis of target lesion
- •2. Severe calcifications with an undilatable lesion during balloon predilatation (Percutaneous Transluminal Renal Angioplasty [PTRA] could be considered)
- •3. History of bleeding diathesis
- •4. Untreated significant lesion greater than 50% diameter stenosis remaining proximal or distal to the target intervention
- •5. Patient has suffered a stroke or Transient Ischaemic Attack (TIA) within the past six months
- •6. Known untreatable malignancy
- •7. Any major surgery planned or required during the next nine months
- •8. Acute myocardial infarction
- •9. Allergy to contrast and/or required antiplatelet medication
- •10. Left main coronary artery
研究者
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