Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions

Launched by BOSTON SCIENTIFIC CORPORATION · Sep 1, 2006

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Eligibility criteria

• General Inclusion Criteria:
• • 1. Patient is ≥18 years old.
• • 2. Eligible for percutaneous coronary intervention (PCI)
• • 3. Documented stable angina pectoris or unstable angina pectoris with documented ischemia, or documented silent ischemia
• • 4. Left ventricular ejection fraction (LVEF) of ≥25%
• • 5. Acceptable candidate for coronary artery bypass grafting (CABG)
• • 6. Patient or legal guardian understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
• • 7. Willing to comply with all specified follow-up evaluations
• Angiographic Inclusion Criteria:
• • 1. Only one lesion appropriate for direct stenting (typically covered by one 24 mm stent or shorter), may be treated with the study stent. However, one additional lesion in a non-target vessel may be treated during the index procedure with a commercially available bare metal stent, heparin-coated stent or TAXUS Express stent.
• • 2. Target lesion located within a single native coronary vessel
• • 3. Target lesion enrolled for treatment may be composed of multiple lesions(not more than 10mm between diseased segments) but must be completely covered by one study stent.
• • 4. Cumulative target lesion length is ≥10 mm and ≤28 mm (visual estimate) and is typically considered appropriate for direct stenting
• • 5. RVD of ≥2.5 mm to ≤4.0 mm (visual estimate)
• • 6. Target lesion diameter stenosis ≥50% (visual estimate)
• • 7. Target lesion is de novo (i.e., a coronary lesion not previously treated)
• General Exclusion Criteria:
• • 1. Known hypersensitivity to paclitaxel
• • 2. Any previous, concurrent or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.
• • 3. Previous or planned use of both the study stent and a non-study stent (i.e., commercial stent) in the treatment of the target vessel
• • 4. Previous or planned treatment with intravascular brachytherapy in the target vessel
• • 5. Planned CABG ≤9-months post-index procedure
• • 6. MI within 72 hours prior to the index procedure and/or creatine kinase(CK) \>2x the local laboratory's ULN unless CK-MB is \<2x ULN.
• • 7. Cerebrovascular Accident (CVA) within the past 6 months
• • 8. Cardiogenic Shock
• • 9. Acute or chronic renal dysfunction
• • 10. Contraindication to ASA, or to both clopidogrel and ticlopidine
• • 11. Patient is currently on warfarin or it is anticipated that treatment with warfarin will be required during any period within 6 months after the index procedure.
• • 12. Leukopenia
• • 13. Thrombocytopenia
• • 14. Active peptic ulcer or active gastrointestinal (GI) bleeding
• • 15. Known allergy to stainless steel
• • 16. Any prior true anaphylactic reaction to contrast agents
• • 17. Patient is currently, or has been treated with paclitaxel or other chemotherapeutic agents within 12-months of the index procedure
• • 18. Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
• • 19. Male or female with known intention to procreate within 3 months after the index procedure
• • 20. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating
• • 21. Life expectancy of less than 24-months due to other medical condition
• • 22. Co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
• • 23. Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
• Angiographic Exclusion Criteria:
• • 1. Unprotected left main coronary artery disease (patient with protected left main disease can be enrolled only if the target lesion is in the RCA)
• • 2. Target lesion is ostial in location (within 3.0 mm of vessel origin)
• • 3. Target lesion and/or target vessel proximal to the target lesion is moderately or severely calcified by visual estimate
• • 4. Target lesion and/or target vessel proximal to the target lesion is tortuous
• • 5. Target lesion is located within or distal to a \>60 degree bend in the vessel
• • 6. Target lesion involves a bifurcation with a diseased (\>50% stenotic)branch vessel \>2.0 mm in diameter
• • 7. Target lesion is totally occluded (TIMI flow\<1) at baseline
• • 8. Angiographic presence of probable or definite thrombus
• • 9. Pre-treatment of the target vessel at the index procedure is not allowed with any device
• 10. A previously treated lesion within the target vessel:
• • \<15 mm from the target lesion (visual estimate)
• • Performed \</= 6 months from index procedure
• • \>30% residual stenosis after previous treatment
• • 11. Predilation with a balloon catheter of the target lesion and/or target vessel is not allowed.