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

Phase 3

Completed

• Conditions: Coronary Disease
• Interventions: Device: CoStar Paclitaxel Drug Eluting Coronary Stent System; Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent

• Registration Number: NCT00165035
• Lead Sponsor: Cordis Corporation

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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Primary Completion: 2007-01
• Study Completion: 2011-07
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-03
• Last Update Posted: 2011-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1701

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CoStar Paclitaxel Drug Eluting Coronary Stent System	CoStar™ Paclitaxel-Eluting Coronary Stent, a reservoir based DES
2	TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent	TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Christ Linder; 🇺🇸 Cincinatti, Ohio, United States