An international, multicenter 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.

Dr. Phillipe Brunel0 个研究点目标入组 400 人开始时间: 待定最近更新: 2024年2月28日

研究概览

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•1. Patients with stable angina pectoris (CCSC1234) or unstable angina and documented ischemia or silent ischemia;
•2. Patient eligible for coronary revascularisation;
•3. The target lesion has a major native coronary artery (>2.5mm) with a stenosis > 50% (on visual assessment) located at a side branch (>2mm);
•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 32mm);
•7. Other lesions in different vessels are successfully treated before the treatment of the target lesion (residual stenosis <30%, stent well deployed, no residual dissection, normal TIMI flow, no chest pain, ECG unchanged compared to pre-procedural ECG;
•8. Only one target lesion can be included in the study;
•9. Signed patients informed consent.

•1. Patients with in stent restenosis of target lesion;
•2. Severe calcifications with an undilatable lesion during balloon predilatation (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 TIA within the past 6 months;
•6. Known untreatable malignancy;
•7. Any major surgery planned or required during the next 9 months;
•8. Acute Myocardial Infarction;
•9. Allergy to contrast and/or required antiplatelet medication;
•10. Left Main coronary artery.

发起方

Dr. Phillipe Brunel