Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial (COSTAR II)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Coronary Disease

Intervention / Treatment
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* Device: CoStar Paclitaxel Drug Eluting Coronary Stent System
* Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent


Participation Criteria
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Eligibility Criteria
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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 Known allergy to stainless steel or cobalt chromium Any prior true anaphylactic reaction to contrast agents Patient is currently taking colchicine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CoStar™ Paclitaxel-Eluting Coronary Stent, a reservoir based DES | Device: CoStar Paclitaxel Drug Eluting Coronary Stent System<br>* Drug eluting stent<br>|
| Active Comparator: 2<br>TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent | Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent<br>* Drug eluting stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death |  | 8 months | 
| In-segment late lumen loss |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous coronary intervention (PCI), Drug eluting stent (DES)