Multi-Center, Single-Blind, Two-Arm, Randomized, Controlled, Non Inferiority Trial of the Conor CoStar Paclitaxel-Eluting Coronary Stent System vs the TAXUS DES in Patients With De Novo Lesions of the Native Coronary Arteries
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Coronary Disease
- Sponsor
- Cordis Corporation
- Enrollment
- 1701
- Locations
- 2
- Primary Endpoint
- MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the investigational stent CoStar™ Paclitaxel-Eluting Coronary Stent- a reservoir based DES system in comparison to a surface coated DES stent (TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent) in the treatment of single-vessel (one blood vessel) and multi-vessel (two or three blood vessels) coronary artery disease.
Detailed Description
Non -inferiority in 8-month Major Adverse Cardiac Events (MACE) and in-segment late lumen loss at 9 months between the CoStar™ Paclitaxel-Eluting Coronary Stent System and the TAXUS™ Express2™ Drug Eluting Coronary Stent System for the treatment of a single de novo lesion per vessel in patients with single and multi-vessel coronary disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •General Inclusion Criteria:
- •Eligible for percutaneous coronary intervention (PCI)
- •Documented stable or unstable angina pectoris (Class I, II, III or IV), documented ischemia, or documented silent ischemia
- •Documented LVEF ≥25% within the last 6 weeks.
- •Eligible for coronary artery bypass graft surgery (CABG)
Exclusion Criteria
- •General Exclusion Criteria:
- •Known sensitivity to paclitaxel or polymeric matrices: Translute or PLGA.
- •Planned treatment with any other PCI device in the target vessel(s).
- •MI within 72 hours prior to the index procedure
- •Patient is in cardiogenic shock
- •Cerebrovascular Accident (CVA) within the past 6 months
- •Acute or chronic renal dysfunction (creatinine \>2.0 mg/dl or \>150 µmol/L)
- •Contraindication to ASA or to clopidogrel
- •Thrombocytopenia
- •Active GI bleeding within past three months
Outcomes
Primary Outcomes
MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death
Time Frame: 8 months
In-segment late lumen loss
Time Frame: 9 months
Secondary Outcomes
- Device, lesion and procedure success(At procedure or hospital discharge)
- Incidence of MACE(30 days, 9 months and 12 months)
- Coronary angiography in the angiographic cohort(9 months)
- Target lesion revascularization(8 months)