Coronary Artery Disease
Conditions
Brief summary
TAXUS ATLAS Direct Stent is a global, multi-center, single-arm, noninferiority trial comparing results from patients in whom the TAXUS Liberté stent was directly implanted (direct stenting) versus results from patients in whom implantation with the TAXUS Liberté stent was preceded by balloon angioplasty (pre-dilatation). The Control group consists of patients in the main TAXUS ATLAS trial, in which pre-dilatation was mandatory. The primary objective is to compare outcomes of direct stenting with balloon catheter pre-dilatation. The primary hypothesis is that late outcomes with direct stenting of the TAXUS™ Liberté Paclitaxel-Eluting Coronary Stent System will be non-inferior to conventional implantation with balloon catheter pre-dilatation
Interventions
DEVICETAXUS Liberté™-SR
Paclitaxel-Eluting Coronary Stent System
Sponsors
Boston Scientific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis segment percent diameter stenosis at 9-months | 9 Months |
Secondary
| Measure | Time frame |
|---|---|
| Utilization parameters (equipment utilization, procedure time, fluoroscopic time and amount of contrast used) | 9 Months |
| MACE rates at discharge, 1, 4 and 9-months and 1, 2, 3, 4, and 5 years post-index procedure | 5 Years |
| Stent thrombosis rate | 5 Years |
| Secondary Endpoints: Clinical procedural and technical success | 5 years |
| Target Vessel Revascularization (TVR) | 5 Years |
| QCA parameters (binary restenosis rate, in-stent %DS, MLD and late loss) | 9 Months |
| IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume) | 9 Months |
| Target Vessel Failure (TVF) | 5 Years |
Countries
New Zealand, Singapore, Taiwan, United States
Outcome results
None listed