Coronary Artery Disease
Conditions
Brief summary
TAXUS ATLAS Small Vessel is a global, multi-center, single-arm, trial of patients with coronary arteries less than 2.5 mm in diameter who are treated with the TAXUS Liberté stent versus an historical TAXUS Express control derived from a subset of lesion-matched TAXUS V patients treated with a 2.25 mm stent. The objective of the study is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions. The hypothesis is that the TAXUS Liberté-SR stent has non-inferior safety and efficacy to the TAXUS Express-SR stent in the treatment of de novo lesions in small coronary vessels.
Detailed description
TAXUS ATLAS Small Vessel is a global, multi-center, single-arm, trial of patients receiving the TAXUS Liberté-SR 2.25 mm paclitaxel-eluting stent. The results will be compared with two different historical control groups. The first control group consists of a subset of lesion-matched TAXUS V patients treated with a 2.25 mm TAXUS Express-SR paclitaxel-eluting stent. The objective of this analysis is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions versus the TAXUS Express-SR stent. The hypothesis is that the TAXUS Liberté-SR stent has non-inferior safety and efficacy to the TAXUS Express-SR stent in the treatment of de novo lesions in small coronary vessels. The second control group consists of a subset of lesion-matched TAXUS V patients treated with either a 2.5 mm or a 2.25 mm bare metal Express stent. The objective of this analysis is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions versus the Express bare metal stent. The hypothesis is that the TAXUS Liberté-SR stent has superior safety and efficacy to the Express bare metal stent in the treatment of de novo lesions in small coronary vessels.
Interventions
DEVICETAXUS Liberté-SR
Paclitaxel-Eluting Coronary Stent, 2.25 mm
DEVICETAXUS™ Express2
Paclitaxel-Eluting Coronary Stent System
DEVICEExpress2
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 at least 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 at least 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 (target lesion) 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 avaiable bare metal stent, heparin-coated stent or TAXUS Express stent. 2. Successful predilation is mandatory for entry into study 3. Target lesion located within a single native coronary artery 4. 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. 5. Cumulative target lesion length is greater than or equal to 10 mm and less than or equal to 28 mm (visual estimate) 6. Target lesion RVD of 2.25 mm \[2.2 - 2.5 mm (visual estimate)\] 7. Target lesion diameter stenosis at least 50% (visual estimate) 8. 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. 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 within 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. Leukopenia 12. Thrombocytopenia or thrombocytosis 13. Active peptic ulcer or active gastrointestinal (GI) bleeding 14. Known allergy to stainless steel 15. Any prior true anaphylactic reaction to contrast agents 16. Patient is currently, or has been treated with paclitaxel or other chemotherapeutic agents within 12-months of the index procedure 17. Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure 18. Male or female with known intention to procreate within 3 months after the index procedure 19. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating 20. Life expectancy of less than 24 months due to other medical condition 21. 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 22. 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 |
|---|---|
| Percent diameter stenosis - analysis segment at 9 months | 9 Months |
Secondary
| Measure | Time frame |
|---|---|
| Utilization parameters (equipment utilization; catheters, guidewires and balloons, 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 |
| 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 |
| Target Vessel Failure (TVF) | 5 Years |
Countries
New Zealand, Singapore, United States
Outcome results
None listed